Natco Pharma files ANDA with FDA for generic version of Tamiflu

Feb 9 2011

Alvogen, the US-based pharmaceutical company, today announced that its India-based partner, Natco Pharma Limited, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for the generic version of Tamiflu^® (oseltamivir phosphate). Both Natco and Alvogen believe it is the first substantially completed ANDA filing containing a Paragraph IV certification and expect to qualify for 180 days of marketing exclusivity upon final FDA approval. Oseltamivir phosphate capsules are used in the treatment of bird and swine flu infections and sold by Hoffman - La Roche under the brand name Tamiflu^®. According to IMS Health in 2009, Tamiflu^® had U.S. sales in excess of US$1 billion.

"The ANDA filing of oseltamivir represents a significant milestone for Alvogen in the U.S. market," said Robert Wessman, Executive Chairman of Alvogen. "We are confident that the filing will qualify for 180-day exclusivity upon FDA approval and we expect the product to offer significant value to our customers and patients. While we are steadily growing our product pipeline through partnerships, our internal capabilities still form an important cornerstone of our development strategy. We will continue our journey of growth and expansion as we move towards our goal of positioning Alvogen among leading global generics companies."

A fast growing product portfolio - Alvogen has built a dynamic product pipeline of more than 200 products, of which 70 are for the U.S. market. Currently, Alvogen has over 200 marketing authorizations pending regulatory approval, representing US$21 billion in annual global sales, according to IMS Health. The company aims to submit over 100 marketing authorizations in the U.S. and Europe in 2011 and launch over 100 products in its markets.

Offices around the world - Alvogen continues to grow its marketing network and has identified over 20 emerging markets in Europe, Asia and Latin America as its priorities for entry. Through a highly refined selection process, Alvogen targets complex generic products that have the potential for reduced market competition. The company has built an industry-leading internal development capability and a strong and effective network of industry partners that continue to support Alvogen's ambitious growth plans.

Source: Alvogen