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WASHINGTON, Mar 29, 2001 (United Press International via COMTEX) -- Mylan Laboratories and Watson Pharmaceuticals received U.S. regulatory approval to produce a generic version of the anxiety drug BuSpar, which had been closely held by Bristol-Myers Squibb as the sole patent holder.
Mylan and Watson both companies announced Wednesday that they had received federal approval to manufacture individual versions of BuSpar -- the brand name for buspirone -- ending what had been 4-month patent battle with Bristol-Myers.
Under the terms of the approval, Mylan is entitled to 180 days of exclusivity as the seller of a generic 15 mg dosage version of BuSpar while Watson will produce a generic 5 mg and 10 mg dose of BuSpar under the same terms.
In a drug market where the battle of less-expensive generic drugs vs. patent drugs has been heated, the BuSpar case is being viewed by the industry as a potential benchmark.
Bristol-Myers had argued this case based on a new patent for BuSpar, which would have effectively extended its patent on the drug. A federal judge, however, ruled this month that Mylan should be allowed to produce its own generic version of the drug after the firm filed a complaint against Bristol-Myers.
The decision was temporarily stayed by an appeals court which lifted the stay Tuesday, saying Bristol-Myers had "not established a likelihood of success on the merits."
Mylan and Watson received subsequent permission from the Food and Drug administration to begin producing their own versions of the anxiety drug. As part of this process, Bristol-Myers requested the BuSpar be taken off the FDA "Orange Book" of patented drugs.
"Mylan has overcome significant legal and regulatory obstacles to bring buspirone (BuSpar) to the marketplace" said Mike Puskar, Mylan CEO. "Mylan won a significant victory for our industry as well as the consumer. We are proud of this important approval and the financial benefits it will bring to American consumers."
During the exclusivity period, a drug company will usually offer its generic product at a significant discount ranging from 30 percent to 50 percent. After the exclusivity period, other companies can then enter into selling generic versions of the drug, which will then usually be available at up to an 80 percent discount.
An additional class of 18 brand-name drugs, totaling $37 billion in sales, are set to lose their patent protections in the next five years when their original patents run out.
Both Mylan and Watson said they would immediately begin producing and shipping
their generic versions of BuSpar, but added that they did not expect sales to
significantly impact their respective current financial quarters because of the
limited shipping days remaining.
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