Ranbaxy in bid to make generic version of Nexium

Share this article:
AstraZeneca said Tuesday that India's biggest drug maker, Ranbaxy Laboratories, has filed an Abbreviated New Drug Application (ANDA) with the FDA to make its own version of the ulcer treatment Nexium (esomeprazole magnesium delayed-release capsules).
Nexium is AstraZeneca's top seller, bringing in $3.8 billion in revenue in 2004.
AstraZeneca is already fighting a challenge to Nexium from Indian generic drug maker Dr. Reddy's Laboratories.
AstraZeneca has 45 days within which to commence a patent infringement lawsuit against Ranbaxy that would automatically stay, or bar, the FDA from approving Ranbaxy's ANDA for 30 months or until a court decision, whichever comes first.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.