This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies

1. BITS Pilani
Pilani Campus
UNDERSTANDING
GENERIC VS
INNOVATOR BUSINESS

2. BITS Pilani, Pilani Campus
• Generic medicines are those where the
original patent has expired and which may
now be produced by manufacturers other
than the original innovator company,where
as innovator drugs are original R&D drugs
whose patent is not expired
• Generics are defined by the World Health
Organisation (WHO), to mean a
pharmaceutical product which:
Generic Medicines
07/08/2012 2MBA C413

3. BITS Pilani, Pilani Campus
is usually intended to be interchangeable
with an innovator product
 is manufactured without a licence from
the innovator company, and
is marketed after the expiry date of the
patent or other exclusive rights

4. BITS Pilani, Pilani Campus
• The main principles under pinning the safe and effective use of
generic medicines is the concept of bioequivalence.
• The FDA’s formal definition of bioequivalence is:
• The absence of a significant difference in the rate and extent to
which the active ingredient or active moiety in pharmaceutical
equivalents or pharmaceutical alternatives becomes available at the
site of drug action when administered at the same molar dose under
similar conditions in an appropriately designed study
• Innovator companies make high investments in R&D to discover
new drugs.
• Development of a major drug costs up to US$ 500 million
• Requires as long as 10-15 years to be introduced into the market

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• Innovators, hungry for profits and
struggling against poor pipelines are
fighting fire with fire and plunging into
generics
• Generics, fighting a hypercompetitive, low
margin business and too few patent
expiries

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7. BITS Pilani, Pilani Campus

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GENERIC(ANDA) VS
INNOVATOR ( NDA)

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• It is also known as patent term restoration act
• It strives balance between generic and branded
drugs
• New drug application and clinical submission
process will fall in one of two categories either
NDA or ANDA
• ANDA is delineated with response to BE
requirement and is submitted to 505(j)
application and clinical submission
HATCHWAXMANN ACT

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• 505 b(1) – Application is used for approval
of ND whose AI has not been previously
approved
• Requires extensive data to establish
Safety and effectiveness of drug, Identity,
strength,quality,purity of drug
• Labelling should be appropriate and
contains all information
TYPES OF NDA

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• Approval of NDA under section 505b(1)
is granted by FDA only after phase 1,2,3
• 505b(2) – Application for approval of new
drug that relies atleast in part of data not
developed by applicant
• 505(j) - Application is used for approval
of generic version of drug that has
already been approved

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• Relies on FDA finding that previously
approved RLD is safe and effective
• Must provide information to establish that
provided generic is same as RLD in AI,
strength, Dosage form ,Route of
administration
• Must demonstrate that proposed generic
is BE to RLD

13. BITS Pilani, Pilani Campus
• An applicant files an Abbreviated New Drug
Application (or “ANDA”) with the Food and Drug
Administration (FDA) and seeks to demonstrate
therapeutic equivalence to a specified, previously
approved “reference listed drug”.
• When an ANDA is approved, the FDA publishes
patent information and add the drug to its Approved
Drug Products list, known as “Orange Book”, and
annotates the list to show equivalence between the
reference listed drug and the approved generic
APPROVAL OF
GENERICS

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• NDA applicant must submit following
information for each patent
• Patent no and patent date on which it will
expire
• Type of patent
• Name of patent owner
• Name of agent of patent owner or
applicant

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• When an applicant submits an ANDA to FDA
applicant must certify one of 4 things under
section 505(j) 2(A) (vii)
• Para 1- Patent information relating to such
patents has not been filed
• Para 2 – Patent has expired
• Para 3 – Patent will expire on particular date
• Para 4 – Patent is invalid
TYPES OF PATENT CERTIFICATES

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The certificate has to make one of the following
statements:
I. No patent information on the drug product
that is the subject of the ANDA has been
submitted to FDA
II. That such patent has expired
III. The date on which such patent expires
IV. That such patent is invalid or will not be
infringed by the manufacture, use, or sale
of the drug product which the ANDA is
submitted

17. BITS Pilani, Pilani Campus
• The first three paragraphs (I, II, III)
results in no generic drug being sold
during the term of the innovator’s patent
protection.
• In case paragraph IV certification
generic drugs can be sold during the
term of the innovator’s patent protection.
with rule of 45days suit and 30 months
ban.

18. BITS Pilani, Pilani Campus
• Para 4 filling is done for generics
• Generics provide notice to brand within 20
days of acceptance
• Brand must bring lawsuit within 45 days
• Generic- If sued, automatic 30 month stay
granted to brand
PARA 4 FILLING

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• NCE – 5 Years
• Non- NCE – 3 Years
• Orphan Drug – 7 Years
• Pedriatics – 6 months
• Generic products – 180 days
• Patent Term Extension or Patent Term
Restoration
• Up to five (5) years to compensate for the delay
before approval of the drug
MARKET EXCLUSIVITIES

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• Limitations:
• The extension requires a valid and unexpired patent
• Only one patent may be extended per approved drug
• Extension period calculated on a day-by-day basis
and is based on time spent in trials and time spent by
FDA review
• Maximum of 14 years of patent term from the date of
approval of the drug

21. BITS Pilani, Pilani Campus
• The SWOT analysis is an extremely useful
tool for understanding and decision-
making for all sorts of situations in
business and organizations.
• SWOT is an acronym for Strengths,
Weaknesses, Opportunities, Threats
SWOT ANALYSIS

22. BITS Pilani, Pilani Campus
Strength and
weakness
Internal
environment
Eg Factors relating
to product, pricing,
cost,profitability,
Performance,
quality,
people,reputation
Factors tend to be in
present
Opportunities and
threats
External
environment
Eg Factors relating
to Market,sector,
audience,fashion,
economics ,politics,
Competition,law
Factors tend to be in
future

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Strengths Weakness
Capability Gaps in capability
Resources, assets Financials
Experience,Knowledge Continuity ,supply chain
robustness
Price,quality,data Cash flow
Managment Reliability of data
Marketing Lack of competitive
strength
USP Deadlines

24. BITS Pilani, Pilani Campus
Opportunities Threats
Market development Political effects
Global influence Legislative effects
Seasonal,weather,fashion
influence
Environmental effects
Technology development
and innovation
Obstacles faced
Major contracts and
tenders
Employment market
Information and research Competitors intention

25. BITS Pilani, Pilani Campus
Pfizer vs DRL
• In February 1986, Pfizer was granted a patent on a class
of compounds that treats heart disease and
hypertension.
• The patent covered the molecule amlodipine, including
two of its salts—amlodipine besylate and amlodipine
maleate.
• In 1987, Pfizer filed another application for amlodipine
besylate salt specifically, as studies conducted showed it
was superior in treating hypertension, and marketed it as
Norvasc.
CASE STUDY

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• As the patent’s expiry date approached (Feb 25, 2006),
Pfizer went ahead and filed a Patent Term Extension
(PTE) under the Hatch-Waxman extension rules
• Meanwhile, in 2002, DRL tried to get approval for
manufacture of AmVaz under the generics category in
view of the significant returns estimated at $200 million
over a three-year period.
• DRL filed an ANDA for same under US FDA’s 505(b)2,
seeking marketing pproval after it was found the PTE by
Pfizer was only for amlodipine besylate

27. BITS Pilani, Pilani Campus
• On October 31, 2002 US FDA granted approval
to DRL to go ahead. However, Pfizer sued DRL
for patent infringement, insisting that PTE
covered the entire scope of amlodipine.
• Pfizer lost the case in a New Jersey district court
in Dec 2002 but won the same in a higher court
in February 2004, thus putting an end to DRL
attempts to tap a lucrative market in the generics
segment.
VERDICT

28. BITS Pilani, Pilani Campus
Thank You!