lipitor patent litigation between Pfizer and Ranbaxy

1. LIPITOR LITIGATION
Presented By:
YOGESH GARG
M. PHARMA (2nd Sem., Pharmaceutics)
170740009

2. CONTENT
 Introduction
 Lipitor Pfizer Legal Battles
 Ranbaxy Met Big Downfall In 2011
 Ranbaxy Recalls Two Lots Of Generic Lipitor In
U.S.
 Big Blow For Singh Brothers
 References

3. INTRODUCTION
What is Lipitor?
• LIPITOR (atorvastatin calcium)
• Lowers the LDL-C ("bad” cholesterol) and triglycerides
• Raise your HDL-C ("good" cholesterol)

4. Lipitor Litigation
• Pfizer had sued Ranbaxy Laboratories, accusing the
company of infringing a US patent for the best-selling
cholesterol medicine Lipitor.
• Pfizer says Ranbaxy’s US unit has applied to the US
Food and Drug Administration to market a generic
version of Lipitor.
• The federal lawsuit was filed on Friday in Delaware,
asked a judge to prohibit Ranbaxy from making and
marketing the drug before Pfizer's 1987 US patent
expires in 2010.

5. LIPITOR PFIZER LEGAL BATTLES
• 17 Dec 2006 Friday, Pfizer Inc. won a major court victory, when a Federal
judge in Delaware, ruled in its favor in a patent fight over its blockbuster
drug Lipitor, an $11 billion best-seller used by more than 18 million
Americans.
• U.S. District Judge Joseph J. Farnan ruled that two patents covering
atorvastatin, the active ingredient in Lipitor, were being infringed upon by a
generic version of the drug made by Ranbaxy Laboratories Ltd.
• Ranbaxy officials said Friday that they will appeal the federal court
decision.
• With Friday's U.S. ruling, Lipitor's exclusivity is protected until June 2011.
• In Oct 2007, Ranbaxy lost a court battle over Lipitor's patents in England.

6. RANBAXY MET BIG DOWNFALL IN 2011
• Ranbaxy Met Big Downfall in 2011 Second Quarter On Friday, it
has been reported by Ranbaxy Laboratories that its shares have been
down by 2.51% in the second quarter. They have met a 25% fall in
their net profit during the period.
• Recently, it has come into knowledge that this Gurgaon- based
company, in order to look out for a solution for its regulatory issues,
is working with the US authorities of Food and Drug Administration
and the Department of Justice.
• As told by Arun Sawhney, who is the managing director of Ranbaxy,
"We remain optimistic going ahead to protect our business and
resolve the issue".

7. RANBAXY RECALLS TWO LOTS OF
GENERIC LIPITOR IN U.S.
• India-based generic drug maker Ranbaxy Laboratories has issued a
recall of generic versions of the cholesterol drug Lipitor in the U.S.
because of potential dosage issues.
• The company recalled more than 64,000 bottles of 10-milligram
tablets of atorvastatin calcium—the active ingredient in Lipitor—
saying some bottles could possibly contain a higher dose, the U.S.
Food and Drug Administration said in a note.
• Ranbaxy confirmed the recall on Friday, noting that the recall started
in mid-January. Notice of the recall was posted on the FDA's
website this week.

8. BIG BLOW FOR SINGH BROTHERS
•2006: US FDA issues warning letter to Ranbaxy’s Paonta Sahib facility
•2007: A whistle-blower’s lawsuit alleges Ranbaxy defrauded Federal programs
•Jun 2008: Daiichi Sankyo acquires majority stake in Ranbaxy
•Sep 2008: FDA imposes import alert on Ranbaxy’s Paonta Sahib and Dewas factories; bans 30
drugs
•May 2013: Criminal charges filed; Ranbaxy agrees to pay a fine of $500 million
•Sep 2013: US bans imports from Ranbaxy’s new formulations factory in Mohali
•Nov 2013: Daiichi Sankyo accuses Singh brothers of hiding information regarding
investigations, files a case in Singapore court
•Jan 2014: US FDA bans imports from Ranbaxy’s main API factory in Toansa
•Apr 2014: Sun Pharmaceutical acquires Ranbaxy in a $4-bn deal
•Sep 2015: Shivinder Mohan Singh steps down, joins Radha Soami Satsang Beas, an Amritsar-
based spiritual organization

9. REFERENCES
• https://www.lipitor.com/what-lipitor-does visited on 27/01/2018
• https://www.cnbc.com/2014/03/07/indias-ranbaxy-issues-massive-
recall-of-generic-lipitor.html visited on 28/01/2018
• http://www.thehindu.com/todays-paper/tp-business/Pfizer-wins-
Lipitor-patent-case/article15292186.ece visited on 28/01/2018
• http://www.topnews.in/ranbaxy-met-big-downfall-2011-second-
quarter-2337406 visited on 29/01/2018
• https://www.reuters.com/article/us-lipitor-lawsuit/pfizer-ranbaxy-
win-dismissal-of-lawsuit-over-generic-lipitor-
idUSKBN0H72FS20140912 visited on 29/01/2018