In the coming year, four drugs representing $10 billion in sales last year in the United States may lose patent protection and be replaced with generic versions.
The four products vulnerable to competition are:
- Astra Zeneca’s acid reliever Prilosec, "the original purple pill" ($3.5 billion).
- Schering Plough’s non-sedating antihistamine Claritin ($2.6 billion).
- Bristol-Myers Squibb diabetic agent Glucophage ($2 billion).
- Lisinopril (blood pressure medicine) sold by Merck as Prinivil and by Astra Zeneca as Zestril ($1.7 billion).
The launch of Glucophage and Lisinopril appear to be the only two drugs for certain that will have generic versions. Glucophage’s exclusivity actually ended late January 2002, but not without a stroke from the pen of President Bush.
Bristol Myers Squibb (BMS) had effectively blocked the generic version from coming to market since September 2000. BMS argued the generic version did not include pediatric information in which they had exclusivity (this drug would not commonly be prescribed for children).
On January 4, the Best Pharmaceuticals for Childrens Act was signed into law, granting the FDA the authority to approve generics without protected pediatric labeling.
At this time, it appears there will not be any legal maneuvering by Merck for Prinivil (Lisinopril) to delay the June 29 patent expiration.
Patent expirations for both Prilosec and Claritin are questionable at best. Astra Zeneca and Schering are suing competitors in an attempt to delay the entry of generics for the two drugs.
Every month of delay represents an additional $350 million in Prilosec sales for Astra Zeneca. It is also fair to note both companies are rolling out successor drugs in the mean time. They hope to shift patients to the newer agents before any generic products are available.
The way it is now, it’s very difficult to determine when a patent or exclusivity will end and when a generic version will be allowed to enter the market.
The tactics of delay by the large pharmaceutical manufacturers are not going unnoticed in Washington, D.C.
In addition to the Best Pharmaceutical for Childrens Act, there are efforts underway urging Congress to address drug patent loopholes created by the Waxman Hatch Act in 1984.
Supporters are eyeing the Prescription Drug User Fee Act as a vehicle to close loopholes in the Waxman Hatch Act.
What does all this mean? The push to correct the problems are most likely coming from the realization that generics could go a long way in making a Medicare drug benefit a possibility.
It is well-documented that generic drugs offer patients, employers, and payors less costly alternatives to brand name drugs. The recent patent expiration of Prozac is a good example.
Before the patent expiration last August, Prozac cost most patients or payors slightly more than $80 per month. This month, with generic competition, the generic version of Prozac (fluoxetine) should cost less than $10 per month.
Only time will tell if 2002 will be the blockbuster year for generic competition. Maybe pharmaceutical manufacturers should spend a little more on research and development and a little less on litigation.
One thing is for certain, unless there is legislative reform, generic drug availability will continue to be decided by the judicial system. IBI