SlideShare une entreprise Scribd logo
1  sur  56
Télécharger pour lire hors ligne
Patent cliff
PATENT CLIFF(2012-2015)
Presentation by
Peruka Venkata Ramana Prasad
1st Semester, MBA(Pharm)
Department Of Pharmaceutical Management
NIPER
 What is patent cliff
Global blockbusters by revenue& patent expiration
Global drug sales at risk from patent expiration
Fall down of companys annual revenue
Key drugs in pipeline
Frequency of NME approvals may come down
Big pharma job cuts announced since 2009
FLOW OF PRESENTATION
Increasing merges &acquisitions
Hatch-waxman act-1984
Patent exclusivity & generic entry regulations
Generics will dominate the market
ENTERING “pharmering markets”
Patent wars
Contd..
It is most often described as an industry-wide
expiration of the patents of a number of
blockbuster drugs with a combined of $250 billion
in annual sales will go off-patent by 2015, creating
a life-threatening situation for many of the top
companies in pharma sector
WHAT IS PATENT CLIFF
Source : Evaluate Pharma,2012
Other sectors, such as software and consumer
goods, have patents. But they rely on rapid
innovation to maintain sales.
In pharmaceuticals, stringent regulations on
authorization and marketing impose tighter
controls, higher costs and longer lead times,
making drug developers more reliant on patent
monopolies to recoup their costs
Why only pharma field is more worried?
KEY GLOBAL PLAYERS
Source : Individual company financials online 2012
GLOBAL BLOCKBUSTERS BY REVENUE&
PATENT EXPIRATION
Source : Bioassociate Consulting & Management Ltd
Source : Evaluate Pharma,2012
Patent Expiration Of Drugs By Year
Source : IMS Global Insight, 2011
Source : IMS Global Insight, 2011
Source : IMS Global Insight, 2011
Source : IMS Global Insight, 2011
Global drug sales at risk from Patent Expiration
Source : Evaluate Pharma Vantage 2010
Forecasted revenues of few blockbuster Post-generification
Source : The Economist,2011
PFIZER – US$30 Lipitor , viagra
Eli lilly- US$13(50%rvnu) Evista , zyprexa
&Cymbalta
Takeda- 52%revenue loss Actos
Forest labs- 52%revenue loss Lexapro
Gsk,Novartis,bms,A&Z- 14-40%revenue loss
Fall Down Of Companies Annual Revenue
Source : Price watercoopers,2011
2009-2013 annual patent losses by company
Source : Bio associate Consulting & Management Ltd
Over $280 billion spent on R&D over last decade
Source : Bioassociate Consulting & Management Ltd
Key drugs in Pipeline
Source : Analyst and company reports,2012
Frequency of NME approvals may come down
Source : US FDA , 2012
2012 : 28NME’s
Big Pharma job cuts announced since 2010
Source : FiercePharma.com,2012, Price watercoopers 2010
Increasing Merges &Acquisitions
2011 –Sanofi-Aventis- Genzyme- -US$20Bn. -Biotech
2011 – Novartis - Aires pharm – US$250Mn -Cystic fibrosis
pnemonia
2011 – Amgen - Biovex -- US$1Bn -Cancer vaccine
Oncovex
2009 –Pfizer - Wyeth - US$68 -Fill pipeline,
Biologics
2009 –Merck -Schering-plough-US$41.1 -18NME’s in
pipeline
2009, 563 deals worth US$161.2Bn took place
Patent cliff
Source : Pfizer,2012
Contd..
Merges in 2012
Source: business-beacon.com, 2012
Acquisitions in 2012
Source: business-beacon.com, 2012
Contd..
29
For Innovator companies
 Patent term extension
 Provides New drug product exclusivity
 30 months stay for ANDA approval
For Generic manufacturers
 Created “Abbreviated New drug Application” approval
process for generic versions of innovator drugs
File ANDAs with bioequivalence data using innovator
product
180 day exclusivity for first-to-file
Certification regarding each patent listed in the Orange
Book for the product: four certification options
Hatch-Waxman Act-1984
30
Paragraph I
Paragraph II
Paragraph IV
Paragraph III
Patent information
has not been filed
Patent has Expired
Patent is invalid or
non-infringed by
Generic applicant
Patent has NOT expired
but will expire on a
particular date
FDA may approve ANDA
immediately
FDA may approve ANDA on
the date that the patent expires
Generic applicant provides notice
to patent holder & NDA filer;
entry of the first filer
may or may not occur
ANDA Patent certification Options
Source : Orange book
Patent exclusivity & Generic entry regulations
Contd..
Source : DataMonitor,2011:US FDA,2012;
According to IMS Health, generics drugs accounted
for 57.7% of prescriptions dispensed five years ago, and
close to 75% today
Price of the drugs will be reduced
However, while the generic drug industry will
certainly benefit in the short term from the patent cliff
Generics will dominate the market
GENERICS ; US$ 100 Bn/pa
ETHICAL MANUFACTURES ; US$ 720 Bn/pa
It is estimated that by 2014 generic market will reach
US$124Bn.
Source : IMS Health, 2012
LEADING GLOBAL GENERIC PLAYERS
Source : Individual company financials 2012
Generics offer Drugs at low cost
Contd..
Source : Blue cross blue shield of michigan
ENTERING “Pharmering Markets”
Source : IMS Health,2011
Contd..
Source : IMS Health,2011
INDIA has large domestic market.
Highest number of US FDAApproved manufacturing
Units (74) outside the US.
Clinical trial hub
Less manufacturing cost
High CAGR
Contd..
PATENT WARS
Law suits & legal loopholes are the last resort before
a patent cliff for innovators
30 Month marketing stay for brand name drugs as part
of patent Infringement litigation, which provides
immunity against generics.
Patent ever greening
In the end, the financial future of many
pharmaceutical companies will depend on how they
manage the transition of many of their brand drugs
to the generic market,
as well as on their own efforts to develop novel
therapeutics and diagnostics with significant profit
potential, and to adapt to the changing global
business climate.
However, while the generic drug industry will
certainly benefit in the short term(upto 2015) from
the patent cliff.
CONCLUSION
T H A N K Y
O U
Let’s get going ….
43
BACK UP SLIDES
During 180 day exclusivity
AG competition typically reduces a first-filer
generic’s revenues during the 180 days of marketing
exclusivity by approximately 50 percent.
To prevent this loss of revenue, a generic may be
willing to delay its entry in return for a brand’s
agreement not to launch an authorized generic –
that is, a brand’s agreement not to compete with the
generic through an AG – during the generic’s 180
days of marketing exclusivity.
7. STRATERGIES TO MINIMIZE THE IMPACT OF PATENT CLIFF
Most obviously, there has been continued investment in
new drug discovery and development of a “pipeline” of
promising agents that address unmet medical needs and
are profitable.
Enhanced advertising over the past decade in an attempt
to optimize earnings prior to patent expiration
A number of drug companies have suggested that they will
outsource at least some of their manufacturing to places
such as Eastern Europe, India, and China, where drug
products can be made at significantly less. But Quality
issues will become severe.
Some pharmaceutical companies already are entering
into agreements with generic manufacturers, licensing
them the right to sell “authorized generics” identical to
branded drugs that have gone or will go off patent.
In an Economist article, it is revealed that
Pfizer worked with an American firm in order
to help break apart a 180 day generic exclusivity
period, helping the company compete with often
times cheaper generics. These practices have
helped to boost sales by over half a billion in the
first half of 2012, taking at least some of the pain
of the patent expiration out of the equation
Patent cliff
Patent cliff
Patent cliff
Patent cliff
Patent cliff
Companies with the biggest
cash reserves
Novartis $15 billion
Roche $13.5 billion
Johnson & Johnson $13 billion
Merck & Co. $10 billion
GlaxoSmithKline $9.5 billion
HYDERABAD: Dr Reddy's Laboratories has agreed to buy
the entire equity holding of the Dutch injectable specialty
generics manufacturer OctoPlus NV for 27.39 million euro (
192 crore) in an all-cash deal.
The Hyderabad-based company said on Monday that
OctoPlus' expertise in making improved injectable
pharmaceuticals based on proprietary drug delivery
technologies and focus on medicine ingredients that are
difficult to formulate complement it capabilities.
Source: business-beacon.com, 2012

Contenu connexe

Tendances

Regulations of Import, Sale and Manufacture of Neutraceuticals in India
Regulations of Import, Sale and Manufacture of Neutraceuticals in IndiaRegulations of Import, Sale and Manufacture of Neutraceuticals in India
Regulations of Import, Sale and Manufacture of Neutraceuticals in IndiaSanthiNori1
 
Drug approval in US, EU & India
Drug approval in US, EU & IndiaDrug approval in US, EU & India
Drug approval in US, EU & IndiaSweta Yadav
 
Intellectual Property Rights
Intellectual Property RightsIntellectual Property Rights
Intellectual Property RightsKishan Pawde
 
Auditing of manufacturing facilities by international regulatory agencies ppt
Auditing of manufacturing facilities by international regulatory agencies pptAuditing of manufacturing facilities by international regulatory agencies ppt
Auditing of manufacturing facilities by international regulatory agencies pptTek kaushik
 
Patent Overview in Novartis Case ppt
Patent Overview in Novartis Case pptPatent Overview in Novartis Case ppt
Patent Overview in Novartis Case pptBizand Legis
 
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)RaghaviPillai
 
Compulsory licensing in the light of novartis ag case and Bayer Corp case
Compulsory licensing in the light of novartis ag case and Bayer Corp caseCompulsory licensing in the light of novartis ag case and Bayer Corp case
Compulsory licensing in the light of novartis ag case and Bayer Corp caseSandeep K Bohra
 
Cadila Pharmaceuticals R&D Presentation
Cadila Pharmaceuticals R&D PresentationCadila Pharmaceuticals R&D Presentation
Cadila Pharmaceuticals R&D PresentationRishab Agrawal
 
ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.
ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.
ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.Raj Aryan
 
FDA Regulation of Advertising and Promotion -- the Basics
FDA Regulation of Advertising and Promotion -- the BasicsFDA Regulation of Advertising and Promotion -- the Basics
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
 
Introduction to Patent Law
Introduction to Patent LawIntroduction to Patent Law
Introduction to Patent LawMichael E. Dukes
 
Disclosures in Clinical Trials
Disclosures in Clinical TrialsDisclosures in Clinical Trials
Disclosures in Clinical TrialsRajendra Dhande
 
Informed Consent Form ppt
Informed Consent Form pptInformed Consent Form ppt
Informed Consent Form pptShitalDesale1
 
Imdrf tech-131209-samd-key-definitions-140901
Imdrf tech-131209-samd-key-definitions-140901Imdrf tech-131209-samd-key-definitions-140901
Imdrf tech-131209-samd-key-definitions-140901Pankaj Srivastava
 
Pharmaceutical legislation
Pharmaceutical legislationPharmaceutical legislation
Pharmaceutical legislationTiyaPatel2
 

Tendances (20)

Regulations of Import, Sale and Manufacture of Neutraceuticals in India
Regulations of Import, Sale and Manufacture of Neutraceuticals in IndiaRegulations of Import, Sale and Manufacture of Neutraceuticals in India
Regulations of Import, Sale and Manufacture of Neutraceuticals in India
 
Regulatory Control of Clinical Trials
Regulatory Control of Clinical TrialsRegulatory Control of Clinical Trials
Regulatory Control of Clinical Trials
 
Drug approval in US, EU & India
Drug approval in US, EU & IndiaDrug approval in US, EU & India
Drug approval in US, EU & India
 
Intellectual Property Rights
Intellectual Property RightsIntellectual Property Rights
Intellectual Property Rights
 
Auditing of manufacturing facilities by international regulatory agencies ppt
Auditing of manufacturing facilities by international regulatory agencies pptAuditing of manufacturing facilities by international regulatory agencies ppt
Auditing of manufacturing facilities by international regulatory agencies ppt
 
Patent Overview in Novartis Case ppt
Patent Overview in Novartis Case pptPatent Overview in Novartis Case ppt
Patent Overview in Novartis Case ppt
 
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
 
Compulsory licensing in the light of novartis ag case and Bayer Corp case
Compulsory licensing in the light of novartis ag case and Bayer Corp caseCompulsory licensing in the light of novartis ag case and Bayer Corp case
Compulsory licensing in the light of novartis ag case and Bayer Corp case
 
Ctd
CtdCtd
Ctd
 
Cadila Pharmaceuticals R&D Presentation
Cadila Pharmaceuticals R&D PresentationCadila Pharmaceuticals R&D Presentation
Cadila Pharmaceuticals R&D Presentation
 
Inside the FDA
Inside the FDAInside the FDA
Inside the FDA
 
ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.
ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.
ICMR Guidelines: Presenter :Raj Kishor [CRC], Tech Observer The global CRO.
 
FDA Regulation of Advertising and Promotion -- the Basics
FDA Regulation of Advertising and Promotion -- the BasicsFDA Regulation of Advertising and Promotion -- the Basics
FDA Regulation of Advertising and Promotion -- the Basics
 
What is Al Jazeera Plus?
What is Al Jazeera Plus? What is Al Jazeera Plus?
What is Al Jazeera Plus?
 
Introduction to Patent Law
Introduction to Patent LawIntroduction to Patent Law
Introduction to Patent Law
 
Disclosures in Clinical Trials
Disclosures in Clinical TrialsDisclosures in Clinical Trials
Disclosures in Clinical Trials
 
Informed Consent Form ppt
Informed Consent Form pptInformed Consent Form ppt
Informed Consent Form ppt
 
Imdrf tech-131209-samd-key-definitions-140901
Imdrf tech-131209-samd-key-definitions-140901Imdrf tech-131209-samd-key-definitions-140901
Imdrf tech-131209-samd-key-definitions-140901
 
Pharmaceutical legislation
Pharmaceutical legislationPharmaceutical legislation
Pharmaceutical legislation
 
Rights of a patentee
Rights of a patenteeRights of a patentee
Rights of a patentee
 

Similaire à Patent cliff

Contract Manufacturing In India
Contract Manufacturing  In IndiaContract Manufacturing  In India
Contract Manufacturing In Indiakaushik2541984
 
Implications for indian_pharmaceuticals
Implications for indian_pharmaceuticalsImplications for indian_pharmaceuticals
Implications for indian_pharmaceuticalsAkshay Bawa
 
Global Pharmaceutical Contract Manufacturing Resource Pack 2011
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Global Pharmaceutical Contract Manufacturing Resource Pack 2011
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Veronica Araujo
 
Ip iamyearbook report
Ip iamyearbook reportIp iamyearbook report
Ip iamyearbook reportAranca
 
Ip iamyearbook-report1
Ip iamyearbook-report1Ip iamyearbook-report1
Ip iamyearbook-report1Aranca
 
Corporate Financial Analysis - Momenta Pharma
Corporate Financial Analysis - Momenta PharmaCorporate Financial Analysis - Momenta Pharma
Corporate Financial Analysis - Momenta PharmaAmrutha Rajendra
 
Impact Of Lipitor Patent Expiry On Pfizer.
Impact Of Lipitor Patent Expiry On Pfizer.Impact Of Lipitor Patent Expiry On Pfizer.
Impact Of Lipitor Patent Expiry On Pfizer.Angela Ruiz
 
The future of the pharma industry 11.07
The future of the pharma industry 11.07The future of the pharma industry 11.07
The future of the pharma industry 11.07Maria Zaritskaya
 
Actavis Pharmaceutical Company Essay
Actavis Pharmaceutical Company EssayActavis Pharmaceutical Company Essay
Actavis Pharmaceutical Company EssaySheri Elliott
 
Are there reasons for believing that the profitability of the industry might ...
Are there reasons for believing that the profitability of the industry might ...Are there reasons for believing that the profitability of the industry might ...
Are there reasons for believing that the profitability of the industry might ...Global Study Solutions - 9901366442
 
The Security Of Pharmaceutical Use Essay
The Security Of Pharmaceutical Use EssayThe Security Of Pharmaceutical Use Essay
The Security Of Pharmaceutical Use EssayNavy Savchenko
 
Dendreon Presentation
Dendreon PresentationDendreon Presentation
Dendreon Presentationafa4
 
Merck Paper Securities and Protfolio Analysis
Merck Paper Securities and Protfolio AnalysisMerck Paper Securities and Protfolio Analysis
Merck Paper Securities and Protfolio AnalysisJason Sandoy
 
The Market For Generic Drugs
The Market For Generic DrugsThe Market For Generic Drugs
The Market For Generic DrugsTiffany Surratt
 
C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)
C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)
C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)Ambika Shevade
 
Dendreon Strategic Analysis
Dendreon Strategic AnalysisDendreon Strategic Analysis
Dendreon Strategic Analysisafa4
 
Micro Chips Consolidated Statement Of Operations For The...
Micro Chips Consolidated Statement Of Operations For The...Micro Chips Consolidated Statement Of Operations For The...
Micro Chips Consolidated Statement Of Operations For The...Lauren Barker
 
A review of marketing
A review of marketingA review of marketing
A review of marketingNilesh Shah
 

Similaire à Patent cliff (20)

biotech
biotechbiotech
biotech
 
Contract Manufacturing In India
Contract Manufacturing  In IndiaContract Manufacturing  In India
Contract Manufacturing In India
 
Implications for indian_pharmaceuticals
Implications for indian_pharmaceuticalsImplications for indian_pharmaceuticals
Implications for indian_pharmaceuticals
 
Global Pharmaceutical Contract Manufacturing Resource Pack 2011
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Global Pharmaceutical Contract Manufacturing Resource Pack 2011
Global Pharmaceutical Contract Manufacturing Resource Pack 2011
 
Ip iamyearbook report
Ip iamyearbook reportIp iamyearbook report
Ip iamyearbook report
 
Ip iamyearbook-report1
Ip iamyearbook-report1Ip iamyearbook-report1
Ip iamyearbook-report1
 
Corporate Financial Analysis - Momenta Pharma
Corporate Financial Analysis - Momenta PharmaCorporate Financial Analysis - Momenta Pharma
Corporate Financial Analysis - Momenta Pharma
 
Impact Of Lipitor Patent Expiry On Pfizer.
Impact Of Lipitor Patent Expiry On Pfizer.Impact Of Lipitor Patent Expiry On Pfizer.
Impact Of Lipitor Patent Expiry On Pfizer.
 
The future of the pharma industry 11.07
The future of the pharma industry 11.07The future of the pharma industry 11.07
The future of the pharma industry 11.07
 
Actavis Pharmaceutical Company Essay
Actavis Pharmaceutical Company EssayActavis Pharmaceutical Company Essay
Actavis Pharmaceutical Company Essay
 
Are there reasons for believing that the profitability of the industry might ...
Are there reasons for believing that the profitability of the industry might ...Are there reasons for believing that the profitability of the industry might ...
Are there reasons for believing that the profitability of the industry might ...
 
The Security Of Pharmaceutical Use Essay
The Security Of Pharmaceutical Use EssayThe Security Of Pharmaceutical Use Essay
The Security Of Pharmaceutical Use Essay
 
Dendreon Presentation
Dendreon PresentationDendreon Presentation
Dendreon Presentation
 
Merck Paper Securities and Protfolio Analysis
Merck Paper Securities and Protfolio AnalysisMerck Paper Securities and Protfolio Analysis
Merck Paper Securities and Protfolio Analysis
 
The Market For Generic Drugs
The Market For Generic DrugsThe Market For Generic Drugs
The Market For Generic Drugs
 
C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)
C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)
C_R_COURSEWORK_AMBIKA_SHEVADE.docx (1)
 
Dendreon Strategic Analysis
Dendreon Strategic AnalysisDendreon Strategic Analysis
Dendreon Strategic Analysis
 
Presentation
PresentationPresentation
Presentation
 
Micro Chips Consolidated Statement Of Operations For The...
Micro Chips Consolidated Statement Of Operations For The...Micro Chips Consolidated Statement Of Operations For The...
Micro Chips Consolidated Statement Of Operations For The...
 
A review of marketing
A review of marketingA review of marketing
A review of marketing
 

Dernier

SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfHongBiThi1
 
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdfSGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdfHongBiThi1
 
High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)kishan singh tomar
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsMedicoseAcademics
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfMedicoseAcademics
 
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxDNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxMAsifAhmad
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024EwoutSteyerberg1
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfDolisha Warbi
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfDolisha Warbi
 
Different drug regularity bodies in different countries.
Different drug regularity bodies in different countries.Different drug regularity bodies in different countries.
Different drug regularity bodies in different countries.kishan singh tomar
 
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio..."Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio...Sujoy Dasgupta
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyMedicoseAcademics
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communicationskatiequigley33
 
How to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyHow to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyZurück zum Ursprung
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Peter Embi
 
historyofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusanguhistoryofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusangu Medical University
 
Basic structure of hair and hair growth cycle.pptx
Basic structure of hair and hair growth cycle.pptxBasic structure of hair and hair growth cycle.pptx
Basic structure of hair and hair growth cycle.pptxkomalt2001
 

Dernier (20)

SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
 
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdfSGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
SGK RỐI LOẠN KALI MÁU CỰC KỲ QUAN TRỌNG.pdf
 
High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functions
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdf
 
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxDNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
 
GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...
GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...
GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
 
Different drug regularity bodies in different countries.
Different drug regularity bodies in different countries.Different drug regularity bodies in different countries.
Different drug regularity bodies in different countries.
 
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio..."Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before Pregnancy
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communications
 
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
 
How to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyHow to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturally
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024
 
historyofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusanguhistoryofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusangu
 
Basic structure of hair and hair growth cycle.pptx
Basic structure of hair and hair growth cycle.pptxBasic structure of hair and hair growth cycle.pptx
Basic structure of hair and hair growth cycle.pptx
 

Patent cliff

  • 2. PATENT CLIFF(2012-2015) Presentation by Peruka Venkata Ramana Prasad 1st Semester, MBA(Pharm) Department Of Pharmaceutical Management NIPER
  • 3.  What is patent cliff Global blockbusters by revenue& patent expiration Global drug sales at risk from patent expiration Fall down of companys annual revenue Key drugs in pipeline Frequency of NME approvals may come down Big pharma job cuts announced since 2009 FLOW OF PRESENTATION
  • 4. Increasing merges &acquisitions Hatch-waxman act-1984 Patent exclusivity & generic entry regulations Generics will dominate the market ENTERING “pharmering markets” Patent wars Contd..
  • 5. It is most often described as an industry-wide expiration of the patents of a number of blockbuster drugs with a combined of $250 billion in annual sales will go off-patent by 2015, creating a life-threatening situation for many of the top companies in pharma sector WHAT IS PATENT CLIFF Source : Evaluate Pharma,2012
  • 6. Other sectors, such as software and consumer goods, have patents. But they rely on rapid innovation to maintain sales. In pharmaceuticals, stringent regulations on authorization and marketing impose tighter controls, higher costs and longer lead times, making drug developers more reliant on patent monopolies to recoup their costs Why only pharma field is more worried?
  • 7. KEY GLOBAL PLAYERS Source : Individual company financials online 2012
  • 8. GLOBAL BLOCKBUSTERS BY REVENUE& PATENT EXPIRATION Source : Bioassociate Consulting & Management Ltd
  • 9. Source : Evaluate Pharma,2012
  • 10. Patent Expiration Of Drugs By Year
  • 11. Source : IMS Global Insight, 2011
  • 12. Source : IMS Global Insight, 2011
  • 13. Source : IMS Global Insight, 2011
  • 14. Source : IMS Global Insight, 2011
  • 15. Global drug sales at risk from Patent Expiration Source : Evaluate Pharma Vantage 2010
  • 16. Forecasted revenues of few blockbuster Post-generification Source : The Economist,2011
  • 17. PFIZER – US$30 Lipitor , viagra Eli lilly- US$13(50%rvnu) Evista , zyprexa &Cymbalta Takeda- 52%revenue loss Actos Forest labs- 52%revenue loss Lexapro Gsk,Novartis,bms,A&Z- 14-40%revenue loss Fall Down Of Companies Annual Revenue Source : Price watercoopers,2011
  • 18. 2009-2013 annual patent losses by company Source : Bio associate Consulting & Management Ltd
  • 19. Over $280 billion spent on R&D over last decade Source : Bioassociate Consulting & Management Ltd
  • 20. Key drugs in Pipeline Source : Analyst and company reports,2012
  • 21. Frequency of NME approvals may come down Source : US FDA , 2012 2012 : 28NME’s
  • 22. Big Pharma job cuts announced since 2010 Source : FiercePharma.com,2012, Price watercoopers 2010
  • 23. Increasing Merges &Acquisitions 2011 –Sanofi-Aventis- Genzyme- -US$20Bn. -Biotech 2011 – Novartis - Aires pharm – US$250Mn -Cystic fibrosis pnemonia 2011 – Amgen - Biovex -- US$1Bn -Cancer vaccine Oncovex 2009 –Pfizer - Wyeth - US$68 -Fill pipeline, Biologics 2009 –Merck -Schering-plough-US$41.1 -18NME’s in pipeline 2009, 563 deals worth US$161.2Bn took place
  • 26. Merges in 2012 Source: business-beacon.com, 2012
  • 27. Acquisitions in 2012 Source: business-beacon.com, 2012
  • 29. 29 For Innovator companies  Patent term extension  Provides New drug product exclusivity  30 months stay for ANDA approval For Generic manufacturers  Created “Abbreviated New drug Application” approval process for generic versions of innovator drugs File ANDAs with bioequivalence data using innovator product 180 day exclusivity for first-to-file Certification regarding each patent listed in the Orange Book for the product: four certification options Hatch-Waxman Act-1984
  • 30. 30 Paragraph I Paragraph II Paragraph IV Paragraph III Patent information has not been filed Patent has Expired Patent is invalid or non-infringed by Generic applicant Patent has NOT expired but will expire on a particular date FDA may approve ANDA immediately FDA may approve ANDA on the date that the patent expires Generic applicant provides notice to patent holder & NDA filer; entry of the first filer may or may not occur ANDA Patent certification Options
  • 32. Patent exclusivity & Generic entry regulations
  • 34. According to IMS Health, generics drugs accounted for 57.7% of prescriptions dispensed five years ago, and close to 75% today Price of the drugs will be reduced However, while the generic drug industry will certainly benefit in the short term from the patent cliff Generics will dominate the market GENERICS ; US$ 100 Bn/pa ETHICAL MANUFACTURES ; US$ 720 Bn/pa It is estimated that by 2014 generic market will reach US$124Bn. Source : IMS Health, 2012
  • 35. LEADING GLOBAL GENERIC PLAYERS Source : Individual company financials 2012
  • 36. Generics offer Drugs at low cost
  • 37. Contd.. Source : Blue cross blue shield of michigan
  • 39. Contd.. Source : IMS Health,2011
  • 40. INDIA has large domestic market. Highest number of US FDAApproved manufacturing Units (74) outside the US. Clinical trial hub Less manufacturing cost High CAGR Contd..
  • 41. PATENT WARS Law suits & legal loopholes are the last resort before a patent cliff for innovators 30 Month marketing stay for brand name drugs as part of patent Infringement litigation, which provides immunity against generics. Patent ever greening
  • 42. In the end, the financial future of many pharmaceutical companies will depend on how they manage the transition of many of their brand drugs to the generic market, as well as on their own efforts to develop novel therapeutics and diagnostics with significant profit potential, and to adapt to the changing global business climate. However, while the generic drug industry will certainly benefit in the short term(upto 2015) from the patent cliff. CONCLUSION
  • 43. T H A N K Y O U Let’s get going …. 43
  • 45. During 180 day exclusivity
  • 46. AG competition typically reduces a first-filer generic’s revenues during the 180 days of marketing exclusivity by approximately 50 percent. To prevent this loss of revenue, a generic may be willing to delay its entry in return for a brand’s agreement not to launch an authorized generic – that is, a brand’s agreement not to compete with the generic through an AG – during the generic’s 180 days of marketing exclusivity.
  • 47. 7. STRATERGIES TO MINIMIZE THE IMPACT OF PATENT CLIFF Most obviously, there has been continued investment in new drug discovery and development of a “pipeline” of promising agents that address unmet medical needs and are profitable. Enhanced advertising over the past decade in an attempt to optimize earnings prior to patent expiration
  • 48. A number of drug companies have suggested that they will outsource at least some of their manufacturing to places such as Eastern Europe, India, and China, where drug products can be made at significantly less. But Quality issues will become severe. Some pharmaceutical companies already are entering into agreements with generic manufacturers, licensing them the right to sell “authorized generics” identical to branded drugs that have gone or will go off patent.
  • 49. In an Economist article, it is revealed that Pfizer worked with an American firm in order to help break apart a 180 day generic exclusivity period, helping the company compete with often times cheaper generics. These practices have helped to boost sales by over half a billion in the first half of 2012, taking at least some of the pain of the patent expiration out of the equation
  • 55. Companies with the biggest cash reserves Novartis $15 billion Roche $13.5 billion Johnson & Johnson $13 billion Merck & Co. $10 billion GlaxoSmithKline $9.5 billion
  • 56. HYDERABAD: Dr Reddy's Laboratories has agreed to buy the entire equity holding of the Dutch injectable specialty generics manufacturer OctoPlus NV for 27.39 million euro ( 192 crore) in an all-cash deal. The Hyderabad-based company said on Monday that OctoPlus' expertise in making improved injectable pharmaceuticals based on proprietary drug delivery technologies and focus on medicine ingredients that are difficult to formulate complement it capabilities. Source: business-beacon.com, 2012

Notes de l'éditeur

  1. And with that as the introduction and background, I’d like to proceed to the panel to ask them each to take as much time as they want (as long as its under 5 minutes) to address these 2 questions:1. What do you think are the leading changes occurring in the CPU/early phase research environment? 2. What are the most pressing pressures that will impact the future of this environment?