This document discusses patents, generics, and details of specific drugs: - A patent is a government-issued license granting exclusive rights to an invention for a set period of time, usually preventing others from making, using, or selling the invention. - When a drug's patent expires, generic companies can file abbreviated new drug applications (ANDAs) to produce generic versions, increasing competition and lowering drug costs. - The document provides examples of drug patents that have expired and the generic approvals that followed, including details on litigation in some cases.

1. Submitted to,
Dr. T M Pramod kumar
HOD, dept. of
pharmaceutics
JSSCP
Mysuru
Submitted by,
Meghana G S
Dept.of
pharmaceutics
JSSCP
Mysuru

2. What is a patent??
A government authority or licence confering
a right or title for set periods , especially the
sole right to exclude others from
making,using or selling an invention.

3. What if drug gets off patented??
Gives an opportunity for generic players to
come into the market through an ANDA
application.
Development of super generics by applying
an NDA application.

5. NCE:new chemical entities are the innovative drug
molecules of the innovators for which they have
to submit a new drug application(NDA) with
both clinical and non-clinical data and get the
exclusivity/patent for 20 years.
GENERICS:these are off patent version of
branded drugs that are identical and
bioequivalent to the innovator drugs in
terms of dosage form,strength,RoA and
therapeutic effects .for this the companies
have to file an abreviated new drug
application(ANDA) and just have to submit
data related to bioequivalence studies.

6. Super generics:these are recent generic
product categories that are differentiated by
improved pharmacokinetics , delivery,
patient convinience or an improved
manufacturing process and better
therapeutic effects from me too generic
products. For approval an NDA has to be
filed.

14. Drug:Androgel
Innovator company:AbbVie Inc.
Patent expiration date:august 30,2020
Generic approval:perrigo israel pharmaceutics
Mode of application:paragraph 4 certification
ANDA approval.post marketing requirements
for this ANDA.
Market value:1million US $

15. Drug:viagra
innovator company:pfizer
patent expiration date:October 22, 2019
Generic approval:
• April 24,2007: Teva Pharmaceuticals (ANDA #077342)
 April 25, 2011: Apotex (ANDA #091378)
 March 7, 2012: Mylan Pharmaceuticals (ANDA #201171)
 September 26, 2012: Dr. Reddy’s (ANDA #202597)
 November 5, 2012: Watson Labs (ANDA #202506)
 February 25, 2013: Actavis Pharma (ANDA #200165)
 February 28, 2013: Amneal Pharma (ANDA #202023)
 November 6, 2013: Hetero Labs Ltd V (ANDA #202659)
 December 17, 2013: Macleods Pharma (ANDA #202255)
 July 15, 2015: Aurobindo Pharma Ltd (ANDA #203962)
 January 21,2016:Ajantha pharma UK limited(ANDA #206401)

16. Litigations fought:
In October 2010, Pfizer had filed a patent infringement
suit in U.S. District Court for the Southern District of
New York against Mylan, Apotex and Actavis and in
May and June 2011 against Watson Labs and Hetero
Labs. Subsequently, Pfizer announced that it had
entered into settlement and license agreements with
the following ANDA holders under which the
respective companies can launch as early as December
11, 2017, or sooner under certain conditions, subject to
USFDA approval.
Market value:4.3billion US$

17. Drug:Benicar
Innovator company:daiichi sankyo
Patent expiration:october 25,2016
Generic approval:apotex
Litigations fought: in the beginning mylan got a
ANDA approval for paragraph 4 certifications later
the innovator company proved it cannot be a
paragraph 4 certification and thus mylan’s
paragraph 4 certification were thus converted to
paragraph 3 certification although it remained as
paragraph 4 certifications in the orange
book.therefore mylan’s ANDA continued to
receive 180 day exclusivity period.

18. Cont…
apotex put forward a dispute questioning the
orange book patent and gained the ANDA
approval with 180 days exclusivity period.

19. Questions????