Monday, August 2, 2010

Generic Aricept and Namenda Update

I am getting a lot of search hits from Google on the articles I wrote about generic Aricept and Namenda.

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I decided to put up an update that includes the currrent state of affairs on the patent expiration for both Aricept and Namenda and when the generic formulation will be available to consumers in the United States.

In addition, both Pfizer (PFE) and Forest Laboratories (FRX) recently released important information about the new formulations of Aricept and Namenda that will be coming on the market soon.

I am currently trying to obtain information on the dates when we can expect generic Aricept to hit the market. I know many of you are anxious to receive this information.

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The current patent on Aricept expires November, 2010 (it has expired). At the time of this writing there is no currently available information on which manufacturers will be making a generic version of Aricept. However, Teva Pharmaceuticals recently ended its long running patent litigation with Eisai over Aricept. I would expect Teva Pharmaceuticals to bring generic Aricept to the U.S. market as soon as it can.

I would expect this to become a very competitive market in 2011. The greater the competition the lower the expected price.

I am remembering when we paid more than $120 for a 30 day supply of Zocor. We now pay less than $10. I would expect the price of Aricept to drop by 90 percent a year after expiration.

On a separate note.

Eisai Inc. and Pfizer Inc [NYSE: PFE] announced that the U.S. Food and Drug Administration (FDA) approved a new once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease (AD).

Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD, for whom few treatments are available.

Aricept will now be available in Aricept in 5 mg, 10 mg and 23 mg doses.

Full text.


Forest Laboratories, Inc. (FRX) recently settled it patent litigation for Namenda (memantine).

Under the settlement agreements, the first generic versions of memantine would be able to enter the market on January 11, 2015.

Specifically, under the terms of the settlement agreements reached, and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest and Merz will provide licenses to each of Amneal, Watson, Dr. Reddy's, Lupin, Mylan, Orchid, Sun, Teva, Upsher-Smith, and Wockhardt that will permit these companies to launch their generic versions of NAMENDA.

On a separate note.

On June 21. 2010, Forest Laboratories, Inc. (NYSE: FRX) and Merz Pharmaceuticals GmbH announced that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type.

NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA. The safety and efficacy of NAMENDA XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor. The results indicate that patients treated with NAMENDA XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.

Full text.

Also read

The Combination of Aricept and Namenda Helps Slow the Rate of Decline in Alzheimer's Patient


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Bob DeMarco is the Founder and Editor of the Alzheimer's Reading Room (ARR). Bob is a recognized influencer, speaker, and expert in the Alzheimer's and Dementia Community Worldwide. The ARR Knowledge Base contains more than 4,000 articles. Bob lives in Delray Beach, FL.
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