EAST BRUNSWICK, N.J., March 15, 2012 /PRNewswire/ -- Amerigen Pharmaceuticals Limited today confirmed that its subsidiary Amerigen Pharmaceuticals Inc. has filed an Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of BYSTOLIC® with the US Food & Drug Administration ("FDA") and is seeking approval to market its nebivolol hydrochloride tablets prior to expiration of U.S. Patent 6,545,040.
On March 13th 2012, Forest Laboratories and Janssen Pharmaceutica filed suit for patent infringement against Amerigen in the District of Delaware.
Based upon available information, Amerigen believes that it may be a first applicant to file an ANDA for a generic version of BYSTOLIC® containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA for nebivolol hydrochloride tablets be approved by the FDA, Amerigen believes that its product may be entitled to 180 days of generic marketing exclusivity.
For the twelve months ending December 31st, 2011, Forest reported US net sales of BYSTOLIC® of approximately $324MM.
BYSTOLIC® is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in East Brunswick, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Limited, is located in Suzhou, Jiangsu Province. The group has an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese SFDA. Amerigen's focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.
SOURCE Amerigen Pharmaceuticals