In this quarterly report, we look at a few of the companies beginning to make their marks on the US generics market either with their fi nished dose products or active ingredients, and analyze trends and statistics relating to the market as a whole.

1. Image CopyrIght: iStOCKpHOtO
MOVERS AND SHAKERS
A PHARMA MATTERS REPORT
July-September 2010
The Thomson Reuters quarterly report on the U.S. generics
industry uses strategic intelligence and competitive analysis
information from Newport Premium™, the critical product
targeting and global business development system from the
industry authority on the global generics market.

2. In this quarter’s report, we look at the companies beginning to
make their mark on the U.S. generics market with their finished
dose products or active ingredients, and analyze trends and
statistics relating to the market as a whole.
For more information on Thomson Reuters
API Intelligence solutions, including Newport Premium,
visit go.thomsonreuters.com/newport
PHARMA MATTERS | MOVERS AND SHAKERS

3. SeCtiOn i: intrODuCtiOn WHat iS
an anDa?
Industry pressures are continuing to mount for innovators as a
number of blockbusters are losing exclusivity with few new launches An Abbreviated New
Drug Application
to fill the gap. In light of that, it is not surprising that in the third
(ANDA) is the first
quarter, Big Pharma continued its foray into the generics sector step for a generic
and into emerging markets. In September, Abbott completed the drug in the U.S. It
acquisition of Piramal Healthcare’s formulation business in India, is submitted to the
making Abbott the number one pharmaceutical company in India FDA to prove that
the generic version
and giving it access to Piramal’s large portfolio of branded generic
is bioequivalent to
drugs. AstraZeneca’s deal with Aurobindo also gave AstraZeneca the innovator drug
access to both the generics and emerging markets. (See Section IV). in question. On
approval, the generic
Meanwhile, the generic industry, faced with its own challenges, version is added
continued to consolidate. In August, Teva, the world’s leading to the Approved
generic pharmaceutical company, announced that it had completed Drug Products List
the acquisition of Ratiopharm for $4.78B. This made Teva the (“Orange Book”) and
number one generics company in Europe. Ratiopharm commanded the company may
manufacture and
a top position in the German market, where Teva was not a leading market it. An ANDA
player prior to the acquisition. The acquisition also boosted Teva’s may be submitted
sales in Canada. In March, Teva won the bidding for Ratiopharm, before the patent on
beating Pfizer. the innovator drug
expires. However,
Generic companies also continued their pursuit of patent in that case, the
challenges, geographic and portfolio diversification, and positioning ANDA must include a
for biosimilars. certification indicating
that the filer does
Now, let’s take a closer look at Abbreviated New Drug Applications not seek to market
(ANDA) approvals and Paragraph IV patent challenges, as well as the product before
notable deals that took place in the third quarter. the expiry of the
Orange Book-listed
patents (“paragraph
III certification”) or
SeCtiOn ii: anDa apprOvalS that the filer believes
that its product
tOtal a-rateD anDaS by COuntry Of Origin Of does not infringe the
appliCant fOr July tO September 2010 Orange Book-listed
patents or that the
41 Orange Book-listed
patents are invalid
(“paragraph IV
certification”).
29
WHat are “a”
rateD DrugS?
“A” rated drugs
are considered
7 therapeutically
5 4 equivalent and can
3 3 3 2 1 be substituted for
each other. “A” rated
drugs are designated
as AA, AB, AN, AO,
AP, and AT in the
A
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PHARMA MATTERS | MOVERS AND SHAKERS

4. During the third quarter of 2010, U.S.-based companies again
WHat iS a
u.S. Dmf? received the most ANDA approvals, with 41 approvals going
to 24 different corporate groups. During the previous quarter,
A DMF (Drug Master
File) is a confidential
U.S.-based companies had received 62 approvals.
document Indian groups were again in second place, with 29 final approvals
covering a specific
going to nine groups. The quarter before, 19 Indian groups had
manufacturing
facility, process, or
received a total of 44 approvals.
article used in the During the third quarter, companies from Switzerland, Iceland,
manufacturing,
Germany, Japan, Canada, Israel, France, and Jordan also
processing,
packaging, or storing received final approvals.
of a bulk drug. A DMF
is reviewed by the
FDA only if an ANDA grOupS WitH tHe mOSt a-rateD anDa apprOvalS fOr
or NDA referencing July tO September 2010
that particular DMF
is filed. An ANDA 9
or NDA will not be 8
7 7
approved until any
5
issues with the DMF 4
3 3 3 3 3
are resolved. 2
DA
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During the third quarter of 2010, Mylan (U.S.) was again on top
of the list with nine ANDA approvals, down from 18 approvals
the previous quarter, followed by Glenmark of India, with eight
approvals. Aurobindo (India) and Novartis (Switzerland) each
received seven final approvals. Teva, which had been in the top
three during quarters one and two, was only in 7th place this
time with three approvals.
PHARMA MATTERS | MOVERS AND SHAKERS

5. SeCtiOn iii: paragrapH iv CHallengeS WHat iS a
biOSimilar
In the third quarter of 2010, we learned of the first Paragraph IV aCCOrDing
patent challenges on eight active ingredients or combinations, tO u.S.
up from six during the previous quarter. regulatiOnS?
A biosimilar
product is defined
grOupS WitH tHe mOSt patent CHallengeS On reCOrD in the Act to mean
aS Of September 2010 a biological product
that is both “highly
similar to the
reference product
157
notwithstanding
minor differences
in clinically inactive
components” and
for which “there
are no clinically
86 meaningful
84
differences between
65 the biological
61 product and the
49 reference product in
43 terms of the safety,
37
34 33 purity, and potency
29 28
of the product.”
Interchangeability
is defined as a
biological product
Im
Pa td
Lu San
Da Gro p
Ac
Dr
Su Inc
Ap
W
No ab
M
Te
that “may be
yla
at
va
pi
ta
pa
rP
n
ot
iic
va
Re
so
n
Ph
vis
ex
n
hi
Ph
x L eut
rti
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substituted for the
dd
L
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ar
rm
ab
Ph
y's tica
m
m
G
or
or
reference product
ac
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ac
ky
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at
m
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eu
Hf
or omp
ac
Co
without the
ica
tic
ie
eu
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nc
intervention of the
In
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sI
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healthcare provider
nc
an
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rie
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who prescribed the
Lt
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reference product.”
Teva continued to be by far the most prolific filer of ANDAs with
patent challenges. At the time of writing this report, we were
linking the company to challenges on 157 products, up from 152
products the quarter before.
Mylan claimed the second spot with challenges on 86 products,
up from 81 the quarter before, while Novartis (Sandoz) dropped
to third place with links to 84 challenges, up from 83 the
quarter before.
PHARMA MATTERS | MOVERS AND SHAKERS

6. prODuCtS firSt expOSeD tO paragrapH iv CHallengeS, aS repOrteD by
WHat iS a
paragrapH iv tHe fDa betWeen July anD September 2010
CHallenge?
aCtive ingreDient: • SigmaPharm Laboratories has submitted an ANDA with
Bioequivalent adefovir dipivoxil Paragraph IV certification for a generic version of Hepsera
generic versions of
pOSteD by u.S. (adefovir dipivoxil) tablets.
drugs that are not
fOOD anD Drug
protected by patents • The Orange Book lists two patents covering Hepsera tablets.
aDminiStratiOn
can be produced - U.S. Patent 5,663,159 will expire on September 2, 2014.
(fDa):
and marketed in the
august 23, 2010 - U.S. Patent 6,451,340 will expire on July 23, 2018.
U.S. by any company,
subject to FDA branD name: In its notice letter to Gilead, Sigmapharm asserted the
approval. However, a Hepsera®
generic company may invalidity of certain claims of U.S. Patent 5,663,159 and
nDa HOlDer:
obtain FDA approval
gilead noninfringement of other claims. Sigmapharm also claimed
before patent expiry if
it certifies its product
that its proposed product would not infringe U.S. Patent
does not infringe 6,451,340, but did not allege that the patent is invalid or
the listed patents
unenforceable.
or the patents are
invalid (paragraph IV • Cipla has held an active drug master file (DMF) for adefovir
certification). Patent dipivoxil since March 2007. In June 2010, Sigmapharm
holders may then sue submitted a DMF for amorphous adefovir dipivoxil (11.6%
the ANDA filer for
copovidone dispersion).
patent infringement. If
the patent holder sues
aCtive ingreDient: • Tolmar has filed an ANDA with Paragraph IV certification for
the ANDA filer within
calcipotriene, a generic version of Taclonex (calcipotriene/betamethasone
45 days of notification,
betamethasone
the FDA may not
dipropionate
dipropionate) ointment, 0.005%/0.064%
approve the ANDA for • The Orange Book lists three patents covering Taclonex
30 months from the pOSteD by fDa:
date of notification. If July 7, 2010 ointment.
no suit is filed within branD name: - U.S. Patent 5,763,426 and U.S. Patent RE39,706 concern
45 days, the FDA may taclonex® a new crystalline form of calcipotriene. The reissued patent
approve the ANDA at
any time. nDa HOlDer: claims, among other things, calcipotriene monohydrate.
leo pharma
Both patents will expire on June 9, 2015.
- U.S. Patent 6,753,013 includes drug product claims as well
as claims directed to the treatment of psoriasis. That patent
will expire on January 27, 2020.
Leo Pharma has alleged infringement of U.S. Patent
RE39,706 in suits against Tolmar concerning proposed
generic versions of both Taclonex ointment and Dovonex
(calcipotriene) topical cream.
• At the time of the first ANDA submission for a generic version
of Taclonex ointment, there were multiple active DMFs for
each component of the combination on file with the FDA.
PHARMA MATTERS | MOVERS AND SHAKERS

7. aCtive ingreDient: • Teva has submitted an ANDA with Paragraph IV certification
entecavir for a generic version of Baraclude (entecavir) tablets
pOSteD by fDa: • The Orange Book lists only one patent covering Baraclude
august 9,2010
tablets.
branD name:
- U.S. Patent 5,206,244 claims entecavir specifically and will
baraclude®
expire on February 21, 2015.
nDa HOlDer:
bristol-myers Squibb In its notice letter to BMS, Teva asserted the invalidity of
certain claims of the patent and that its proposed product
would not infringe the patent’s other claims.
• Cipla submitted a DMF for entecavir monohydrate on May 21,
2010.
aCtive ingreDient: • Glenmark Generics has submitted an ANDA with Paragraph
hydrocortisone IV certification for a generic version of Locoid Lipocream
butyrate
(hydrocortisone butyrate) cream, 0.1%.
pOSteD by fDa:
• The Orange Book lists only one patent covering Locoid
September 20, 2010
Lipocream.
branD name:
locoid lipocream ® - U.S. Patent 5,635,497 concerns topical application
nDa HOlDer: compositions and will expire on June 3, 2014. Astellas
triax Pharma Europe is the owner of U.S. Patent 5,635,497.
pharmaceuticals
• At the time the first ANDA with Paragraph IV certification was
submitted for a generic version of Locoid Lipocream, Crystal
Pharma, Pfizer, Sicor de Mexico, and Taro held active DMFs
for hydrocortisone butyrate.
aCtive ingreDient: • Natco has submitted an ANDA with Paragraph IV certification for a
lenalidomide generic version of Revlimid (lenalidomide) capsules.
pOSteD by fDa: • The Orange Book lists 12 patents covering Revlimid capsules,
august 23, 2010
expiring between July 24, 2016 and April 22, 2026. The listed
branD name: patents cover the composition of matter, method of use,
revlimid®
polymorphs, and Celgene’s restricted distribution program as
nDa HOlDer: approved by the FDA.
Celgene
Celgene has filed a suit against Natco alleging infringement of 10
of those patents.
• At the time of the first ANDA submission for a generic version of
Revlimid capsules, Mylan held the only DMF for lenalidomide
reported by the FDA. Celgene’s infringement complaint included
the allegation that Natco had entered into an agreement with
an unknown partner under which that partner would market
and distribute Natco’s proposed lenalidomide product upon
FDA approval. Mylan and Natco have cooperated in the past. For
example, in June 2008, Mylan announced a license and supply
agreement for Natco’s glatiramer acetate pre-filled syringes.
PHARMA MATTERS | MOVERS AND SHAKERS

8. aCtive ingreDient: • The companies that have submitted ANDAs with Paragraph
rasagiline mesylate IV certification for generic versions of Azilect (rasagiline
pOSteD by fDa: mesylate) tablets include Mylan, Orchid, and Watson.
august 23, 2010
• The Orange Book lists seven patents covering Azilect tablets,
branD name: expiring between February 7, 2012 and December 5, 2026.
azilect®
In suits against Mylan, Orchid, and Watson, Teva has alleged
nDa HOlDer: infringement of U.S. Patent 5,453,446. That patent is directed
teva
to the use of the R-enantiomers of N-propargyl 1-aminoindan
compounds for the treatment of Parkinson’s disease. It has
been granted an extension of five years under 35 USC § 155
and will now expire on February 7, 2017.
• At the time of the first ANDA submission for a generic version
of Azilect tablets, Actavis, Alkem, Amino, Apotex, Dr. Reddy’s
Laboratories, Mylan, Orchid, Sun, and Teva held active DMFs
for rasagiline mesylate.
aCtive ingreDient: • Nycomed has submitted an ANDA with Paragraph IV
tacrolimus certification for a generic version of Protopic (tacrolimus)
pOSteD by fDa: ointment, 0.1%.
September 20, 2010
• The Orange Book lists two patents covering Protopic
branD name: ointment, 0.1%.
protopic®
- U.S. Patent 5,385,907 includes formulation claims and will
nDa HOlDer:
astellas expire on January 31, 2012.
- U.S. Patent 5,665,727 concerns the treatment of dermatitis
and will expire on September 9, 2014.
• At the time the first ANDA with Paragraph IV certification was
submitted for a generic version of Protopic ointment, 0.1%,
several companies held DMFs for tacrolimus.
aCtive ingreDient: • Mylan has submitted an ANDA with Paragraph IV certification
varenicline tartrate for a generic version of Chantix (varenicline tartrate) tablets.
pOSteD by fDa: • The Orange Book lists three patents covering Chantix tablets.
July 23, 2010
- U.S. Patent 6,410,550 will expire on May 10, 2020.
branD name:
Chantix® - U.S. Patent 6,890,927 will expire on May 6, 2022.
nDa HOlDer: - U.S. Patent 7,265,119 will expire on August 3, 2022.
pfizer According to the Orange Book, all three patents include
claims directed to the drug substance, drug product, and their
use as an aid to smoking cessation. In a suit against Mylan,
Pfizer has alleged infringement of U.S. Patent 6,890,927 and
U.S. Patent 7,265,119.
• At the time the first ANDA for a generic version of Chantix
tablets was submitted, Mylan’s Matrix subsidiary held an
active DMF for varenicline tartrate, as did Actavis, ALP Pharm
Beijing Company, Apotex, and Teva.
PHARMA MATTERS | MOVERS AND SHAKERS

9. SeCtiOn iv: nOtable DealS
Portfolio Diversification
A number of the deals in the third quarter in the generics sector focused on
diversifying companies’ portfolios and positioning them to become players in the
biosimilars arena.
mylan
In September, Mylan announced the acquisition of privately held Bioniche Pharma
Holdings for $550 million. Previously, a private equity group, RoundTable Healthcare
Partners, held a majority stake in the company. Bioniche, based in Galway, Ireland,
generates most of its turnover in the U.S.
In February of this year, Bioniche acquired seven injectable products from
GeneraMedix. In the past, it has also acquired ANDAs and NDAs from Baxter
Healthcare, Nabi Biopharmaceuticals, Xanodyne, Merck, and PharmaForce. The
company claims to have 15 ANDAs pending approval, with more than 25 currently in
pre-filing state.
The acquisition gives Mylan immediate entry into the U.S. injectables market and
helps it build a commercial platform for biogenerics. Mylan plans to combine
Bioniche’s injectable business with its existing UDL Laboratories unit-dose operation.
WatSOn
In July, Watson Pharmaceuticals announced that it had entered into an exclusive,
global licensing deal with Itero Biopharmaceuticals for a recombinant follicle-
stimulating hormone (rFSH) that Itero has in pre-clinical development. The deal is
part of Watson’s plan to build a pipeline of biosimilar products and capitalizes on
the biologics capabilities of the Eden Biodesign business that Watson gained after
acquiring Arrow.
enDO
In August, Endo Pharmaceuticals, based in Pennsylvania, announced that it will pay
$168M for Penwest Pharmaceuticals, a drug delivery technology and formulations
company. The deal allows Endo to retain a larger part of the revenue from Opana
ER (oxymorphone HCl), an opioid painkiller that uses Penwest’s Timerx extended-
release technology. The contract between Endo and Penwest for Opana ER was
originally signed in 1997. The acquisition will allow Endo to apply Penwest’s delivery
technologies across its portfolio of drug products, both branded and generic.
In September, Endo entered into an agreement to acquire Qualitest Pharmaceuticals,
a privately held generics company, for approximately $1.2B in cash. The acquisition
gives Endo a broad range of products and formulation capabilities, including
controlled substances, which make up approximately 40 percent of Qualitest’s
product portfolio, and liquids, which contribute about 17 percent.
Sun pHarmaCeutiCalS
In September, Sun Pharmaceuticals of India announced that it had completed the
acquisition of a controlling stake in Taro Pharmaceutical of Israel. Sun holds 48.7
percent of economic equity interest and 65.8 percent of the voting rights. Taro has
PHARMA MATTERS | MOVERS AND SHAKERS

10. manufacturing facilities in Canada and Israel focused on
topical dose forms, such as creams and ointments, but also for
manufacturing liquids and oral solids. Sun is hoping to build on
Taro’s Canadian and American market presence and expertise
in dermatology.
aCtaviS
Actavis is pursuing an entry into the biosimilars sector through
a proposed acquisition of 51 percent of Bioton’s shares in
Biopartners. Bioton, a Polish biotechnology company, acquired
the Swiss company Biopartners in 2007 for $78M. Biopartners
has long-term strategic partnerships with companies such as
LG Life Sciences and Rentschler Biotechnologie. Actavis has
been reportedly seeking additional deals and partnerships to
gain access to monoclonal antibodies.
Big Pharma’s Interest in Generics
In the third quarter, Big Pharma continued its entry into the
generic sector. In September, Aurobindo of India announced
that it had entered into an agreement with AstraZeneca. The
agreement covers licensing and supply of generic drugs, both
in solid dose form and injectables, to AstraZeneca for sale
in emerging markets. The Aurobindo deal is the second for
AstraZeneca with an Indian generic. In March, AstraZeneca
entered into an agreement with Torrent. Torrent agreed to
supply to AstraZeneca a portfolio of generic medicines that will
be manufactured by Torrent and marketed by AstraZeneca in a
number of emerging markets.
In September, Abbott completed the acquisition of Piramal
Healthcare’s Indian formulations business. In May, Abbott
agreed to pay $3.72B for the business. According to Abbott,
the deal will give them the number one position in the Indian
pharmaceutical market.
SeCtiOn v: Opening mOveS
Based on our research of ANDA filings and Paragraph IV
challenges, we highlight some of the companies making
significant game play in the U.S. generics industry.
SigmapHarm labOratOrieS llC
SigmaPharm, a privately held specialty pharmaceutical
company based in Langhorne, Pennsylvania, is involved in
the development, manufacturing, and marketing of generic
and branded products. The company also provides contract
development and manufacturing services and holds a number of
patents.
PHARMA MATTERS | MOVERS AND SHAKERS

11. SigmaPharm filed its first ANDA in June 2007. It received its
first approval, for amiloride HCl tablets, in January 2009. The
product was launched for commercial marketing, in partnership
with Rising Pharmaceuticals, in April 2009. SigmaPharm also
markets two other products, ergocalciferol and protriptyline HCl,
through Rising.
In August 2010, Gilead Science received a Paragraph IV
notification letter informing them that SigmaPharm had
submitted an ANDA for adefovir dipivoxil, a generic version
of Hepsera, used to treat hepatitis-B. For additional details
regarding the challenge, please see the ‘Paragraph IV patent
challenges’ section of this quarter’s Movers and Shakers.
epiC pHarma, llC
Epic Pharma, based in Laurelton, New York, is a privately held
generic company that came to life only two years ago. The
company has an FDA-approved manufacturing facility, which it
bought from Sandoz (Novartis); Sandoz had planned to close
the facility and outsource the operations.
Epic has continued as a contract manufacturer to Sandoz. The
facility is used for making a number of oral drugs, including
controlled drugs, in immediate, sustained, and delayed release
forms.
Epic currently holds 10 ANDAs, which it has acquired this year
from various companies such as Mylan, Glenmark, Actavis,
Amneal, and others. In March 2009, Epic signed a strategic
alliance agreement with Elite Pharmaceuticals. Under the
agreement, at least eight generic drugs will be developed by
Epic at Elite’s facility. At that time, Epic also invested in Elite
through the purchase of shares of Elite’s stock.
muStafa nevzat ilaC Sanayii aS
Mustafa Nevzat, established in 1923, is one of the oldest
pharmaceutical companies in Turkey and among the first to
manufacture injectable drugs in the country. The company
has four dedicated finished dosage form production plants in
Yenibosna, Istanbul, where it manufactures a wide range of
injectables and oral solids. The company primarily uses active
pharmaceutical ingredients (APIs) produced by Unifar, its sister
company, which manufactures a number of products from its
facilities in Izmit. Both its API and finished dose facilities have
been inspected by the U.S. FDA.
In 2005, Mustafa Nevzat filed its first ANDA. The company
started exporting finished dose products to the U.S. in 2007.
Mustafa Nevzat has strategic partnerships with several U.S.
generic companies, including Par Pharmaceutical Companies
PHARMA MATTERS | MOVERS AND SHAKERS

12. Inc. The two companies entered into an agreement to develop
and market as many as 10 generic injectable pharmaceuticals.
Under the agreement, Mustafa Nevzat would be responsible
for the development and manufacture of the product, while Par
would submit each ANDA to the U.S. FDA on behalf of Mustafa
Nevzat. The agreement stipulated that Par would be responsible
for any litigation expenses arising from the ANDA submissions
and would have exclusive rights to market, sell, and distribute
the products in the U.S.
On May 24, 2007, Mustafa Nevzat and Par sent notice to
Sanofi-Aventis of their ANDA with Paragraph IV certification for
oxaliplatin. On July 6, 2007, Sanofi-Aventis and Debiopharm
sued Mustafa Nevzat and Par in New Jersey District Court
in response to their ANDA for oxaliplatin injection 5mg/mL
in 10mL and 20mL vials. Currently, Mustafa Nevzat holds a
tentative approval for oxaliplatin.
The company holds ANDAs with final approval for pamidronate
disodium and vecuronium bromide. The company acquired
both ANDAs from Generamedix. Mustafa Nevzat had been
manufacturing pamidronate for Generamedix prior to the ANDA
transfer. Mustafa Nevzat has also had contract manufacturing
arrangements with other companies, such as Bioniche Pharma.
PHARMA MATTERS | MOVERS AND SHAKERS

13. Image CopyrIght: reuterS/David gray
NeWport U.S. marKet Share moDULe
Deeper INSIght INto the WorLD’S LargeSt
pharmaCeUtICaL marKet
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