Oct 18, 2010

Generic Aricept -- Patent Due To Expire on November 25, 2010

Generic Aricept (Donepezil) is now available. Prices have come down about $100 for a 30 day supply. We except to see a sharp price decline after the six month exclusivity period ends on May 25, 2011.
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The patent for Aricept expired on November 25, 2010. We should expect to see the generic version of Aricept on the market immediately after that date.

The news might effect the stock price of Pfizer (PFE), although it appears that the news is already built into the market price.

For Alzheimer's disease caregivers and their families that are struggling to afford the price of Aricept the availability of a generic form of the medication certainly come as welcome news.

As of this writing, no one has received the final approval from the FDA to market and sell a generic form of Aricept.

On September 22, 2010, drug maker Ranbaxy announced it had been granted an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug (Aricept) for Alzheimer's in the US.

The press release stated,
The US drug regulator, the Food and Drug Adminisration (FDA), upheld the exclusivity status after it dismissed Israeli drugmaker Teva's claim for a shared marketing exclusivity for the drug.
It is standard operating practice that one generic drug maker gets the exclusive right to market a new generic drug for the first six months.

Ranbaxy, an Indian drug maker, should receive approval at the expiration of the Aricept patent on November 25, 2010 if the information is correct. Ranbaxy is majority owned by Japanese drugmaker Daiichi Sankyo Co.

Not so fast.

Teva Pharmaceutical Industries Ltd., the largest generic-drug maker, is challenging patents on Eisai Co.’s Alzheimer’s treatment Aricept. A U.S. appeals court ruled on October 6, 2010 that Teva can continue its challenge in courts. Teva's goal is to beat Ranbaxy to market with generic Aricept.

The dispute would be moot if Ranbaxy gets approval in November.

So here we are patiently waiting for November 25 and for this situation to resolve.

Regardless of result, we should see more generic drug companies entering the generic Aricept market after the six month exclusivity period.

The more companies that enter the market the lower the potential price for generic Aricept in the year ahead. Competition breeds lower prices.

I should also mention that Pfizer, through its subsidiary Greenstone, is becoming increasingly agressive in the marketing of generic drugs. Pfizer (PFE) was Eisai's partner in the U.S. for Aricept. They might decided to enter the market also.

I'll keep you posted on the dates and let you know when the FDA issues it final approval letter.

It will be interesting to see at what price generic Aricept enters the market, and to see what effects increased competition has after the exclusive six month selling period ends.

More About the Alzheimer's Reading Room
Bob DeMarco is the Founder of the Alzheimer's Reading Room and an Alzheimer's caregiver.

Original content Bob DeMarco, the Alzheimer's Reading Room