Source: Prescription Access Litigation (PAL)

BuSpar® (buspirone hydrochloride) is a widely prescribed anti-anxiety medication manufactured by Bristol-Myers Squibb Co. (BMS). It is a drug frequently prescribed to the elderly and to people with AIDS.

The patent for BuSpar® was scheduled to expire at midnight on November 21, 2000. Just hours before the patent was set to expire, BMS improperly submitted to the Food and Drug Administration (FDA) a new patent for BuSpar®. BMS misrepresented to the FDA that the patent covers a method of using BuSpar®, when instead the patent only covers part of the chemical reaction the drug undergoes once it is ingested. The new patent is not the type of patent that extends a drug manufacturer's right to be the only seller of that drug.

BMS's submission, even though it was false, required the FDA to deny applications from other companies that had requested approval to market generic versions of BuSpar®. One company, Mylan Pharmaceuticals, Inc., had on November 22, 2000 its generic BuSpar® loaded in trucks and ready to ship. But BMS's filing with the FDA prevented Mylan from bringing its generic equivalent of BuSpar® to market.

Mylan sued the government and BMS alleging that BMS's listing of its new BuSpar® patent was improper. On March 14, 2001, United States District Judge Ricardo M. Urbina agreed with Mylan, and ordered BMS to request the FDA to de-list its patent extension. Judge Urbina also ordered the FDA to approve Mylan's application to market a generic version of BuSpar®. On March 28, 2001, the FDA gave Mylan approval to sell its generic version.

The Prescription Access Litigation Project will bring lawsuits against BMS in state courts alleging that by illegally extending its monopoly to sell BuSpar®, BMS has locked generic competitors out of the market since November 22, 2000. As a result of BMS's illegal conduct, indirect purchasers (consumers and health care providers) have paid a higher price for buspirone hydrochloride, than they would have paid had there been effective generic competition. This suit seeks fair and adequate compensation for persons who have been overcharged by BMS's illegal, monopolistic business practices.

The first generic version of a brand name drug to hit the market usually costs 30 to 40 percent less than the brand name drug. Then, as more generic versions become available, prices drop by as much as 70 to 80 percent of the brand name price. As a result of these lower prices, brand name manufacturers generally lose as much as two-thirds of their market share to lower priced generic versions within the two years.

According to Drugstore.com, prices for BuSpar® are as follows:

	90 tablets	270 tablets
5 MG	$72.32	$203.03
10 MG	$121.65	$353.03
	60 tablets	180 tablets
15 MG	$121.19	$351.65
30 MG	$211.40	$633.00

The FDA-approved usual and effective dose for BuSpar® is 30 MG per day, which translates to approximately $100/month for consumers who are paying out-of-pocket for their prescription drugs. Prices for BuSpar® in Canada are approximately one-third less than in the United States.