Kremers Urban Pharmaceuticals Inc. Settles Concerta® Patent Litigation

PRINCETON, N.J., Sept. 13, 2011 /PRNewswire/ -- Kremers Urban Pharmaceuticals Inc. is pleased to announce that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product, for which Concerta® is the reference listed drug product. The ANDA is currently under review with FDA.

The settlement includes a patent license and covenant, under existing ALZA Corporation patents under which Kremers Urban may commercially launch its methylphenidate ANDA product on July 1, 2012, or earlier under certain circumstances, pending FDA approval.

About Kremers Urban

Kremers Urban is the generic subsidiary of UCB. It is a specialty generic pharmaceutical company focused on difficult, "high barrier" to entry generic products. To learn more visit www.kremersurban.com.

For More Information Contact:
Antje Witte, Investor Relations
+49 2173 48 1866
[email protected]

SOURCE Kremers Urban Pharmaceuticals Inc.

Suggested Articles

While the failure might be a missed chance at revenue, it shouldn’t hurt Ibrance’s ability to rack up sales in the metastatic setting, one exec says.

Patients receiving Bavencio actually did worse than those who got placebo, increasing the risk of death by 31%.

Seattle Genetics and Astellas’ newcomer Padcev now has what every cancer drugmaker is looking for: Randomized trial data showing it can extend lives.