Dr Reddy’s faces patent lawsuit from Albany Molecular on Sanofi’s allergy drug Allegra

India’s second largest generic player Dr Reddy’s Ltd is now facing a lawsuit from Albany Molecular Research (AMRI), Inc on alleged infringement of patents pertaining to Sanofi-Aventis’ allergy drug Allegra in which AMRI gets royalties.

Allegra contains fexofenadine as active ingredient. Fexofenadine (Allegra) is used to treat hayfever and similar allergy symptoms. Fexofenadine is considered a drowsiness-free anti allergic drug.

Currently AMRI receives royalties on Allegra products from Isaeli generic maker Teva Inc and Barr Lab Inc following an out of court settlement of a lawsuit against these companies in November 2008.

The settlement allowed Sanofi-Aventis U.S. LLC to sublicense patents related to Allegra and Allegra D-12 to Teva and Barr Laboratories in the United States for which AMRI receives royalties on the sale of products containing fexofenadine hydrochloride and products containing fexofenadine hydrochloride and pseudoephedrine hydrochloride (generic Allegra D-12) by Teva and Barr through 2015, along with additional considerations.

Now AMRI has filed two new patent infringement lawsuits in US District Court in New Jersey against Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc. and Sandoz, Inc.  for infringement of AMRI’s US Patent Number 7,390,906. The recently issued patent relates to the manufacturing process for the active ingredient in Sanofi-Aventis’s Allegra and Allegra D drug products.

AMRI alleges that the generic versions of Sanofi-Aventis’s Allegra and Allegra D drug products for which Dr Reddy and Sandoz are seeking to obtain marketing approval from the USFDA are committing an infringement on its valid patents.

“We believe that this patent infringement filing strengthens our litigation strategy on Allegra, Allegra D-12, and Allegra D-24 against these generic drug companies in the United States and other jurisdictions,” said AMRI chairman, president and CEO Thomas E D’Ambra.

In March 2004, AMRI joined Aventis Pharmaceuticals, Inc. in filing lawsuits pertaining to AMRI’s fexofenadine-related patents. Aventis Pharmaceuticals, Inc. originally filed patent infringement actions in the United States District Court for the District of New Jersey against several generic pharmaceutical manufacturers in 2001 based on patents relating to Sanofi-Aventis U.S. LLC’s Allegra and Allegra’s D-12 products.

Following the 2008 out of court settlement, AMRI entered into an amendment to its licensing agreement with Sanofi-Aventis U.S. LLC to allow it to sublicense Allegra patents. AMRI received an upfront sublicense fee from Sanofi-Aventis US LLC of $10 million.

Sanofi-Aventis also provided royalties to AMRI on the sale of products containing fexofenadine hydrochloride and fexofenadine hydrochloride and pseudoephedrine hydrochloride.

AMRI will continue to receive royalties from Sanofi-Aventis  for the sale of products containing Allegra, Allegra D-12 and authorized generics for the remaining term of the patents. Royalties for the sale of products containing Allegra outside of the United States were not part of this litigation and will continue to be unaffected.

Albany Molecular Research, Inc. (AMRI) is contract research services provider. AMRI fouses on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world’s leading healthcare companies.

In June Albany revamped its Indian operations effecting some changes to its leadership team, supporting the establishment of an integrated offering of chemical development and manufacturing services.