FDA: Paragraph IV Patent Certifications

On July 21, 2015 FDA announced that it received Abbreviated New Drug Application’s (ANDA) with a “Paragraph IV” patent certification for the following drugs.

Drug Name Dosage Form Strength RLD Date of Submission
Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate Tablets 200 mg/25 mg/300 mg Complera 5/20/2015
Memantine HCl Extended-release and Donepezil HCl Capsules 14 mg/10 mg and 28 mg/10 mg Namzaric 5/18/2015

About Complera:

Complera is a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (Emtricitabine and Tenofovir Disoproxil Fumarate) and one non-nucleoside reverse transcriptase inhibitor (Rilpivirine), which was approved to Gilead Sciences INC on Aug 10, 2011. The product was approved to treat HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. The combination is protected by related patents which are listed in the OB, NCE is going to expire on May 20, 2016 and NPP is going to expire on Dec 13, 2016.

About Namzaric:

Namzaric is a combination of Memantine HCl extended-release, a NMDA receptor antagonist, and Donepezil HCl, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients. The combo was approved to Forest Labs LLC on Dec 23, 2014.


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