Finding and evaluating branded and generic market entry opportunities

💊 DrugPatentWatch.com #MAKEBETTERDECISIONS ✉ admin@DrugPatentWatch.com
Finding and Evaluating
Branded and Generic
Market Entry Opportunities
YALI FRIEDMAN, PH.D.
ADMIN@DRUGPATENTWATCH.COM

Outcomes
 Be a value-added partner for your branded and
generic clients
 Anticipate generic entry so you can prepare for
changes in demand
 Find and evaluate generic entry opportunities

More generics = lower prices
Source: FDA

API volume increases after patent expiration

Factors influencing generic entry decisions
Ingredient Recipe and Testing Capital Distribution
Effect
Size
Large Medium Large Medium
Reason Trusted
suppliers
Compound
properties
known
Experience with
form, family, and
ingredient reduces
research
expenditure
Experience with
form reduces
development
cost
Reduces effort
to find
customers
Source: M. Scott Morton, Fiona. (1999). Entry Decisions in the Generic
Pharmaceutical Industry. RAND Journal of Economics. 30. 421-440.

Strong generic first-mover advantage
 1st generic can enjoy 80% market share advantage over 2nd entrant
 Advantage can last for years
Why?
 Supplier decisions based on price, reputation, and recall history
 Switching can introduce inventorying costs
Costs of switching suppliers may favor first entrant
Source: Yu, Y., Gupta S. Pioneering Advantage in Generic Drug Competition International Journal of Pharmaceutical and Healthcare Marketing

Use sales to track demand for drug / category

Branded vs. generic price may indicate competition

Brand and generic may use different channels

Find 505(b)(2) opportunities
New Drug
NDA / 505(b)(1)
Generic Drug
ANDA / 505(j)
Hybrid
505(b)(2)
Contains full reports of
investigations of safety and
effectiveness that were
conducted by or for the
applicant or for which the
applicant has a right of
reference or use.
Relies on FDA’s finding that
a previously approved
reference listed drug is safe
and effective ... May not be
submitted if clinical
investigations are necessary
to establish the safety and
effectiveness of the
proposed drug product.
Contains full reports of
investigations of safety and
effectiveness, where at least
some of the information
required for approval
comes from studies not
conducted by or for the
applicant and for which the
applicant has not obtained a
right of reference or use.
Source: FDA

Most common 505(b)(2) types
New formulation or manufacturer 43%
New dosage form 29%
New combination 13%
Source: Freije, I., Lamouche, S., & Tanguay, M. (2019). Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering
Drug Development Trends and Regulatory Requirements. Therapeutic Innovation & Regulatory Science.

Increase client affinity with authorized generics

Generic drug types
Branded Generic Authorized Generic Traditional Generic
Approval Process ANDA or 505(b)(2) NDA ANDA
Relation to
patent expiration
Sold after patent
expiration
Can be sold before
patent expiration
Sold after drug
patent expiration
Cost Typically more
than unbranded
generic; less than
branded drug
Typically more
than unbranded
generic; less than
branded drug
Typically less
than branded or
authorized
generics

Branded generics

Patent claim types
• If a patent claims the active ingredient it may be impossible to work around
Compound claims
• If a generic entrant can work around a patented production process they may
be able to launch
Process claims
• Patents on specific formulations / dosage forms (e.g. transdermal patch or
autoinjector) do not protect they active ingredient
Formulation / Dosage claims
• If a drug has multiple uses, a generic may launch for unpatented indications
using a skinny label
Use claims

Patent priority cheat-sheet
Extended patents
Litigated patents
Compound-claiming patents
Unexpired patents

Finding low-competition opportunities

Fast-follower: Day-181 Launch

Get intel from patent litigation

$2.3mm to defend patent

25% Royalty

How much was earned?
$100mm royalty payments over 2y implies $200mm/yr in generic sales

Thank You
Yali Friedman, Ph.D.
admin@DrugPatentWatch.com
www.drugpatentwatch.com/make-better-decisions/

Finding and evaluating branded and generic market entry opportunities

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Finding and evaluating branded and generic market entry opportunities