Pfizer is suing Matrix (Mylan) for filing an ANDA to manufacture a version of the blockbuster cholesterol drug Lipitor in 10-, 20-, 40- and 80-mg strength tablets.
Pfizer Inc., the world’s biggest drugmaker, sued rival Mylan Inc. asking a judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017.
Pfizer’s patents on Atorvastatin which are in the light:
US5969156 (Expiry: Jan 8, 2017): Which covers crystalline Polymorphic Form I, II and IV
US6087511 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin.
US6274740 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof.
As per complaint, Matrix (Mylan) has filed ANDA with amorphous form of Atorvastatin and notified innovator about ANDA filing by Paragraph IV notice letter dated May 1, 2009.
In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire.
“Defendants have taken immediate and active steps” to sell Lipitor copies in the U.S. and “Pfizer will be irreparably harmed” if Canonsburg, Pennsylvania-based Mylan succeeds, according to the complaint.
Pfizer officials have said they’re looking for cooperative ventures with other pharmaceutical makers to increase generic sales as patents expire. Lipitor logged $12.4 billion in revenue last year, $7.7 billion of it in the U.S.
Ranbaxy Laboratories Ltd., India’s biggest drugmaker and majority owned by Japan’s Daiichi Sankyo Co., settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and Teva Pharmaceutical Industries Ltd. to prevent them from selling copies of the medicine before then.
Mike Laffin, a spokesman for Mylan, didn’t immediately return voice and e-mail messages seeking comment on the lawsuit.
Pfizer fell 63 cents to $14.13 in New York Stock Exchange composite trading at 4:15 p.m. Mylan fell 56 cents to $13.06 in Nasdaq Stock Market trading.
The case is Pfizer Inc. v. Mylan Inc., U.S. District Court, District of Delaware (Wilmington).
