Generic memantine is a therapeutic equivalent of the brand Namenda.

Two manufacturers have received tentative approval to sell generic Namenda (memantine) from the U.S. FDA. This should mean a substantial drop in the cost of this important medication for dementias such as Alzheimer’s.

The two companies are India’s Wockhardt, as well as India’s Orchid Chemicals & Pharmaceuticals.

The tentative approval is to manufacture and market a generic version of Namenda as memantine hydrochloride tablets. The tentative approval was by the U.S. Food and Drug Administration (FDA). The specific conditional marketing approvals are for the 5mg and 10mg tablets of memantine HCl.

The generic memantine is a therapeutic equivalent of the brand Namenda, marketed in the United States by Forest Laboratories. Namenda (memantine) is prescribed for the treatment of moderate to severe Alzheimer’s disease and other types of dementia.

Namenda (memantine) is the first in a novel class of Alzheimer’s drugs that block NMDA glutamate receptors, according to IMS Health.

Forest’s patents covering Namenda (memantine) is under litigation in the US courts. The total market for memantine tablets in the US is about $1.1 billion. Forest has licensed the patent for Namenda (memantine) from the German pharmaceutical company Merz. The patent expires in April 2010, though Forest is trying to implement some form of an extension through 2015.

Currently, a typical prescription for Namenda can cost $170 per month. It is often prescribed alongside a second medication such as Aricept (generic name donepezil), Exelon (generic name rivastigmine) or Razadyne (generic name galantamine). Any of these can cost about the same, leaving one with an annual cost of $4080.

For those in the U.S. on Medicare Part D for prescriptions, the coverage cap is $2830. So taking these medications leaves a person paying all the rest of the cost beyond that amount, plus the full amount of any other medications, until one is out-of-pocket $4550. (After that, one receives “Catastrophic Coverage” and only pays a small co-pay for any covered medications.)

That makes for a big bill, sometimes even too big a bill, for the average person. With these generic formulations, we can hope to see this medication reach many more people at a lower cost.

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A new study indicates doctors should exercise even more discretion regarding dosage levels of memantine. (Brand names: Namenda, Axura, Ebixa.) Patients and caregivers should pay extra attention to side effects to ensure it is appropriate.

Several prescription drugs are currently approved by the U.S. Food and Drug Administration (FDA) to treat people who have been diagnosed with Alzheimer’s disease (AD).

Tables Comparing Medications to Treat Alzheimer's Disease and Related Dementias

More Information:

U.S. patents owned by Forest Labs and assigned to Germany-based Merz Pharma GmbH & Co. covers formulations of adamantane derivatives that were manufactured and marketed as Namenda. Forest licensed the patents from Merz.

Sources:

Orchid Chemicals & Pharmaceuticals Ltd
Wockhardt Ltd
The Alzheimer's Reading Room

Week of January 10 - January 17, 2009

By Peter Berger, Alzheimer's Weekly.
Reviewed by
Dr. Boaz Ancselovic, MD, Geriatrician, Alzheimer's Weekly.
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