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Amerigen Pharmaceuticalsen Believes That It Is A First Applicant To File An Abbreviated New Drug Application ("ANDA") For Certain Strengths Of Namzaric Containing A "Paragraph IV" Patent Certification Under The Provisions Of The Hatch-Waxman Act



9/5/2017 8:28:40 AM

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LYNDHURST, N.J., Sept. 5, 2017 /PRNewswire/ -- Amerigen Pharmaceuticals Limited ("Amerigen") today announced that, based on the August 7th, 2017 update to the U.S. Food & Drug Administration's online databasea, the Company believes that it is a 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. Allergan currently markets 4 strengths of Namzaric® in the U.S. for the treatment of dementia associated with Alzheimer's Disease, which collectively generated approximately $52 million in sales in the 3 months to the end of June 2017 according 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.

Note (a) Specific reference is made to the FDA's list of drug products for which an ANDA has been received by the Office of Generic Drugs containing a "Paragraph IV" patent certification.
Note (b) 7/10 represents a capsule containing 7mg of Memantine Hydrochloride extended release and 10mg of Donepezil Hydrochloride.
Note (c) 21/10 represents a capsule containing 21mg of Memantine Hydrochloride extended release and 10mg of Donepezil Hydrochloride.

About Amerigen
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 Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group 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. 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.

View original content:http://www.prnewswire.com/news-releases/amerigen-believes-that-it-is-a-first-applicant-to-file-an-abbreviated-new-drug-application-anda-for-certain-strengths-of-namzaric-containing-a-paragraph-iv-patent-certification-under-the-provisions-of-the-hatch-waxman-act-300512609.html

SOURCE Amerigen Pharmaceuticals


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