On February 22nd the Food and Drug Administration (FDA) approved a generic version of GlaxoSmithKleine’s brand name drug Flonase - Fluticasone Propionate Nasal Spray. The drug patent of Flonase expired in May 2004 and the new dosing schedule exclusivity on November 23, 2005.

Par Pharmaceuticals is to distribute Spectrum’s three abbreviated new drug applications, already approved by the FDA and nine more pending approval. The deal includes other abbreviated new drug applications, currently under development. Par and Spectrum will share profits from the sale of the generic drugs. Par Pharmaceuticals will provide further financial and legal support for the ongoing lawsuits against Spectrum for sumatriptan injection, originally developed by GlaxoSmithKline.

Bristol-Myers Squibb today announced an agreement for technology transfer and voluntary license with generic manufacturers Aspen PharmaCare and Emcure Pharmaceuticals for Reyataz ( Atazanavir Sulfate ), the company’s once-daily protease inhibitor for HIV/AIDS that was initially approved in the U.S. in June 2003 for use in combination therapy with other anti-HIV medicines. Bristol-Myers Squibb will grant a royalty-free license to Aspen and Emcure to manufacture and sell atazanavir in sub-Saharan Africa. A separate agreement has been concluded with Emcure covering India.

Under the agreement, Bristol-Myers Squibb will provide a royalty-free license to operate under relevant patents and will transfer to Aspen and Emcure its technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient and the finished dosage form of atazanavir.

Another Indian company Ranbaxy announced it’s joint venture with Community Investment Holdings ( a South African firm). Ranbaxy holds 70% of the venture, named Sonke Pharmaceuticals. This will allow Ranbaxy to sell their anti-Hiv drugs in Africa at a lower cost. They plan to market their drugs not only in South Africa, but also in Namibia and Botswana. Sonke Pharmaceuticals hopes to provide HIV-positive people in these countries with a cheap and effective treatment through public and private facilities.

Merck & Co Inc. granted the Indian drug manufacturer Dr. Reddy’s Laboratories exclusive rights to market generic versions of two Merck drugs - Zocor ( Simvastatin ) and Proscar ( Finasteride ). This allows the Indian company to sell the drugs as authorized generics once they go off-patent. The upcoming expiration of Merck’s Zocor patent had severe consequences for the company - a forced reconstruction took place and 7000 people lost their jobs, Merck’s stocks declined 11 cents.

For Dr. Reddy’s this is a historical success, this is the first Indian drug company to launch authorized generics. This deal allows Dr. Reddy’s to have a 180-day market exclusivity for their generic version.

Our goal is to provide consumers with understandable and up to date information about the growing market of generic drugs. Send us feedback about the articles and what you would like to see in the future. There will be a lot of new content added over the next few months so stay tuned.