5. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
How to anticipate generic entry
ο§How do generic companies make market entry
decisions?
ο§ What indicators can you track in advance of ANDA
approval?
6. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
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.
7. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
Strong generic first-mover advantage
ο§ 1st generic can enjoy 80% market share advantage over 2nd entrant
ο§ Advantage can last for years
Why?
ο§ Supplier decisions based on price, reputation, and recall history
ο§ 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
14. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
Anticipating generic entry
ο§ Combine independent sources
ο§ NDC, DMF, API production
ο§ Volume of litigation can anticipate number of
generic entrants
ο§ Options:
ο§ Partner with first generic entrant (Pfizer + Teva for sildenafil)
ο§ License authorized generic
17. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
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 FDAβs 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
18. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
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.
20. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
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
27. π DrugPatentWatch.com #MAKEBETTERDECISIONS β Yali@DrugPatentWatch.com
Other litigation use cases
ο§ Study 505(b)(2) litigation for strong / weak
patent claims
ο§ Search patent claims for terms used in recently
defeated patents
ο§ Study success rates and tactics of adversaries