Healthcare Industry News:  biosimilar 

Biopharmaceuticals Generics FDA

 News Release - February 5, 2009

Dr. Reddy's Announces Five ANDA Approvals and Generic Product Launches in the US Market

HYDERABAD, India--(HSMN NewsFeed)--Dr. Reddy’s Laboratories (NYSE:RDY ) today announced that it has launched the following five products in the US market during the month of January:
  • Levetiracetam tablets (250mg, 500mg, 750mg & 1000mg), the generic version of UCB Keppra® Tablets – with IMS annual sales of $1.1 billion.
  • Omeprazole capsules (40mg), the generic version of AstraZeneca’s Prilosec® DR Capsules 40mg – with IMS annual sales of $168 mn.
  • Lamotragine CD chewable tablets (5mg & 25mg), the generic version of GlaxoSmithKline’s Lamictal® CD Tablets – with IMS annual sales of $87 mn.
  • Divalproex capsules & delayed release pellets (125mg), the generic version of Abbott’s Depakote® Delayed Release Capsules 125mg – with IMS annual sales of $126 mn.
  • Lamotrigine tablets (25mg, 100mg, 150mg & 200mg), the generic version of GlaxoSmithKline’s Lamictal® Tablets – with IMS annual sales of $2.3 billion.
Note: IMS sales data is based on 12 month sales ending September 2008.


Commenting on the product approvals, Satish Reddy, Managing Director and COO said, “We are excited to announce the launch of these five products as they add additional breadth and depth to our product portfolio and in turn to our customers. Our ability to successfully launch 5 generic products within such a short period of time is a result of the organizational capabilities we have built, and a reflection of our continued commitment to establish a leadership position in the US market.”

About Dr. Reddy’s

Established in 1984, Dr. Reddy’s Laboratories (NYSE:RDY ) is an emerging global pharmaceutical company whose purpose is providing affordable and innovative medicines for healthier lives. Dr. Reddy’s is vertically integrated with a presence across the pharmaceutical value chain through its core businesses of Global Generics, Pharmaceutical Services & Active Ingredients (PSAI), and Proprietary Products, which includes New Chemical Entities, biosimilars and Differentiated formulations. The company’s products are marketed globally, with a focus on India, US, Europe and Russia. Dr. Reddy’s conducts NCE drug discovery research in the areas of metabolic disorders, cardiovascular indications, anti-infectives and inflammation. For further information please see: www.drreddys.com

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.


Source: Dr. Reddy's Laboratories

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