Evaluating innovative portfolios and preparing for branded, 505(b)(2), and generic competition

💊 DrugPatentWatch.com #MAKEBETTERDECISIONS ✉ Yali@DrugPatentWatch.com
Evaluating innovative portfolios
and preparing for branded,
505(b)(2), and generic
competition
YALI FRIEDMAN, PH.D.
YALI@DRUGPATENTWATCH.COM

Outcomes
 Anticipate generic entry
 Anticipate 505(b)(2) entry
 Leverage branding in preferred sales channels
to compete with generics
 Learn from litigation

Patent expirations bring change

More generics = lower prices
Source: FDA

How to anticipate generic entry
How do generic companies make market entry
decisions?
 What indicators can you track in advance of ANDA
approval?

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

For biologics, watch clinical trials

What is the earliest possible generic date

Track litigation

Check Drug Master File Holders
DMF listing may be simultaneous with ANDA filing

Do any generic entrants have NDCs?
Without an NDC there can be no generic!

Anticipating generic entry
 Combine independent sources
 NDC, DMF, API production
 Volume of litigation can anticipate number of
generic entrants
 Options:
 Partner with first generic entrant (Pfizer + Teva for sildenafil)
 License authorized generic

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 competition 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

Get intel from patent litigation

Find licensing agreements

$2.3mm to defend patent

25% Royalty

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

Other litigation use cases
 Study 505(b)(2) litigation for strong / weak
patent claims
 Search patent claims for terms used in recently
defeated patents
 Study success rates and tactics of adversaries

Thank You
Yali Friedman, Ph.D.
yali@DrugPatentWatch.com

Evaluating innovative portfolios and preparing for branded, 505(b)(2), and generic competition

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