Namenda in a Generic Form
Namenda is designed to slow the progression of Alzheimer’s, especially when paired with donezepil, the generic form of Aricept®. It has been a very profitable drug with annual sales in its last fiscal year of roughly $1.5 billion. It is currently selling at Costco for $382.50 for 30 tablets in either the 5 mg or 10 mg strengths.
On Wednesday, July 15, 2015, the patent on Namenda expired. The generic manufacturers were ready and immediately filed applications for approval to manufacture generic versions.
Under the terms of the Hatch Waxman Act, the FDA has approved 2 applications for the manufacture of a new generic form on a shared exclusive basis for the next 180 days. This temporary period of semi-exclusivity is granted if the generic manufacturer attests in its application that (a) its manufacturing will not infringe any patent or (b) the patent is no longer valid. Thus the generic manufacturer is assuming the risk of a potential issue with patent protection during this period.
Generic versions of Namenda should be arriving soon at pharmacies throughout the country under the name of memantine hydrochloride. If past patterns are accurate indications, the price of this generic form of Namenda will drop, but not precipitously, between now and January of 2016.
At that time, the FDA will approve applications of other generic manufacturers, and unfettered competition will begin. In the past, generic prices have dropped between 80 to 85% of the previous cost of the brand name drug. In this case, families can look forward to paying between $57 and $84 for 60 tablets of 5 or 10 mg generic Namenda at this time next year. The FDA takes stringent measures to make sure that the generic vesions of brand name drugs are “bio-equivalent”. For most people, the generic version will be as effective as the brand version.
If someone has been persuaded to switch the Namenda XR, the long release form of the drug, there will be no reduction in its cost. To switch back to the original version, which is taken twice a day, one will need a new prescription.