Amerigen Abbreviated NDA for Certain Strengths of Namzaric Containing a "Paragraph IV" Patent Certification May Be First to be Filed
6 September 2017 - - Lyndhurst, New Jersey-based generics specialist Amerigen Pharmaceuticals Ltd. believes that, based on the August 7th, 2017 update to the US Food and Drug Administration's online database, it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Namzaric 7/10b and 21/10c containing a "Paragraph IV" patent certification under the provisions of the Hatch-Waxman Act, the company said.
Allergan currently markets 4 strengths of Namzaric in the US for the treatment of dementia associated with Alzheimer's Disease, which collectively generated approximately USD52 m in sales in the 3 months to the end of June 2017according to data provided by IMS Health.
Allergan and Amerigen reached a settlement agreement with respect to all litigation arising from Amerigen's ANDA for Namzaric in October 2016.
Amerigen Pharmaceuticals, a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China, has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA.
Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market.