PITTSBURGH, Aug. 29 - Mylan Inc. (NYSE: MYL)
today announced that its subsidiary Alphapharm Pty Limited won a favorable
decision in patent litigation against it and Barr Laboratories Inc.
relating to Galantamine Tablets, USP, the generic version of Ortho-McNeil’s
Razadyne(R) Tablets, 4 mg, 8 mg and 12 mg.
On August 27, the U.S. District Court for the District of Delaware
invalidated the sole “Orange Book” patent (U.S. Patent No. 4,663,318)
asserted against Alphapharm by Janssen Pharmaceutica NV, Janssen LP and
Synaptech Inc. Alphapharm was first to file an Abbreviated New Drug
Application (ANDA), along with other generics companies, for Galantamine
Tablets.
“We are very pleased with the court’s ruling on this first-to-file
patent challenge, which once again continues to underscore our ability to
effectively pursue and monetize Paragraph IV opportunities,” said Mylan
Vice Chairman and CEO Robert J. Coury. “This is yet another example of our
continued and successful commitment to provide affordable medications to
the patients who need them the most.”
The U.S. Food and Drug Administration (FDA) yesterday approved
Alphapharm’s ANDA. Mylan Pharmaceuticals, another Mylan subsidiary, intends
to immediately launch the product on behalf of Alphapharm. Alphapharm and
other applicable ANDA holders will be awarded 180 days of shared marketing
exclusivity.
Razadyne Tablets, indicated for the treatment of mild to moderate
dementia associated with Alzheimer’s disease, had annual U.S. sales of
approximately $102 million for the 12 months ending June 30, 2008, for the
same strengths. Currently, Mylan has 93 ANDAs pending FDA approval, 22 of
which are potential first-to-file opportunities.
Mylan Inc., with a presence in more than 90 countries, ranks among the
leading diversified generic and specialty pharmaceutical companies in the
world. The company maintains one of the industry’s broadest — and highest
quality — product portfolios, supported by a robust product pipeline; owns
a controlling interest in the world’s second largest active pharmaceutical
ingredient manufacturer; and operates a specialty business focused on
respiratory and allergy therapies.
SOURCE Mylan Inc.