Bristol-Myers Squibb, Pfizer file ANDA lawsuits against makers of generic Eliquis

“Bunch of White Oval Medication Tablets and White Medication Capsules” from Pixabay. Public domain.

On Wednesday, April 5th, American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a treatment that helps reduce the risk of stroke in patients with atrial fibrillation. The lawsuits stem from abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) to market generic versions of apixaban, the anticoagulant agent used in Eliquis. The suits have all been filed in the U.S. District Court for the District of Delaware (D. Del.).

Bristol-Myers Squibb and Pfizer are asserting two patents in these cases:

• U.S. Patent No. 6967208, titled Lactam-Containing Compounds and Derivatives Thereof as Factor Xa Inhibitors. It protects a compound which is useful as an inhibitor of trypsin-like serine proteases to serve as an anticoagulant agent for the treatment of thromboembolic disorders.
• U.S. Patent No. 9326945, issued under the title Apixaban Formulations. It discloses a solid pharmaceutical composition comprising a therapeutically effective amount of crystalline apixaban particles which is formulated in such a way to give a more consistent therapeutic effect.

(Image: apixaban.jpg)

These lawsuits target a large number of pharmaceutical companies including Mylan Pharmaceuticals (NASDAQ:MYL) of Canonsburg, PA; the U.S. subsidiary of Indian pharma firm Aurobindo Pharma Ltd (NSE:AUROPHARMA); Breckenridge Pharmaceutical, Inc. of Boca Raton, FL; the U.S. subsidiary of Indian drugmaker Hetero Drugs Limited; InvaGen Pharmaceuticals, Inc. of Hauppauge, NY; Indian drugmaker Lupin Ltd. (NSE:LUPIN); Chinese pharmaceutical firm Sunshine Lake Pharma Co.; Indian pharma firm Torrent Pharmaceuticals Ltd. (NSE:TORNTPHARM); and Indian pharma firm Unichem Laboratories Limited (NSE:UNICHEMLAB).

The charges of patent infringement follow Paragraph IV certifications made by the defendant drugmakers in their ANDAs for generic formulations of apixaban filed with the FDA. A party filing an ANDA makes such a certification to enable their generic product to enter the market before the patent covering a branded pharmaceutical expires. Such a certification declares that those patents covering the branded drug are either invalid, unenforceable or will not be infringed by the manufacture and sale of the generic version. Under the terms of the Hatch-Waxman Act, Bristol-Myers Squibb and Pfizer had to bring action within 45 days of the filing of these ANDAs.

Eliquis has been a profitable drug for Bristol-Myers Squibb and Pfizer, joint developers of the drug. It has taken market share from warfarin treatments by providing similar blood thinning effects with less bleeding incidents in patients taking the drug, exhibiting improved safety. In the third quarter of 2016, Eliquis sales reached $884 million, an increase of about 90 percent over third quarter 2015 sales. Through all of 2016, Eliquis sales reached $3.3 billion, contributing to more than 17 percent of Bristol-Myers Squibb’s total revenues on the year.