[Pharm-policy] Bristol-Myers Block on Generic Buspirone
Brad Cameron
Larry <Larry@ngrc.com>
Mon Dec 4 10:49:03 2000
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Bristol Myers-Squibb (BSM) has initiated a novel legal theory to block generic sales of its
Bispurone product (BuSpar), an anxiety treatment often prescribed for alcohol and drug
dependent patients suffering with AIDS. The Coalition for Pharmaceutical Reform is asking for
assistance in registering objections to the company's abusinve tactics.
BSM obtained a patent last week for the metabolite formed in patient's bodies after they ingest
BuSpar. The company then filed the patent with the FDA on the very day that its original
patent for the drug expired. FDA had given tentative approval to two generic manufacturers
(Watson and Mylan) to begin shipping generic versions of the drug on Nov. 22. Under federal
law, the FDA must now rescind its approval of the generics for 2-1/2 years. Here's a time line
of the BSM strategy to delay generic competition:
* Original patent issued Feb 20, 1973 was to expire on Feb. 20, 1990
* Second patent issued Jan 8, 1980 was set to expire Jan. 8, 1997
* Patent was extended under provisions of the GATT treaty to May 22, 1998
* Patent was extended again uinder provisosions of the Hatch-Waxman Act to May 22, 2000
* The BSM market exclusivity was then extended under provisions of the Pediatric Studies law
to Nov. 22, 2000
* The new Metabolite patent obtained on Nov. 21 will expire on June 6, 2020
Meanwhile, the company is reported to have earned $2.6 billion from the drug since 1986.
Consumers pay over $700 million for the drug, which is likely to drop in cost by up to 75% when
generic forms are allowed on the market. It is anticipated that Congress will be asked to
review this matter.
Please respond to this email if you would like more information, or would like to help us
spread the word.
Brad
>
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Bristol Myers-Squibb (BSM) has initiated a novel legal theory to block
generic sales of its Bispurone product (BuSpar), an anxiety treatment often
prescribed for alcohol and drug dependent patients suffering with AIDS.
The Coalition for Pharmaceutical Reform is asking for assistance in registering
objections to the company's abusinve tactics.
<p>BSM obtained a patent last week for the metabolite formed in patient's
bodies after they ingest BuSpar. The company then filed the patent
with the FDA on the very day that its original patent for the drug expired.
FDA had given tentative approval to two generic manufacturers (Watson and
Mylan) to begin shipping generic versions of the drug on Nov. 22.
Under federal law, the FDA must now rescind its approval of the generics
for 2-1/2 years. Here's a time line of the BSM strategy to delay
generic competition:
<ul>
<li>
Original patent issued Feb 20, 1973 was to expire on Feb. 20, 1990</li>
<li>
Second patent issued Jan 8, 1980 was set to expire Jan. 8, 1997</li>
<li>
Patent was extended under provisions of the GATT treaty to May 22, 1998</li>
<li>
Patent was extended again uinder provisosions of the Hatch-Waxman Act to
May 22, 2000</li>
<li>
The BSM market exclusivity was then extended under provisions of the Pediatric
Studies law to Nov. 22, 2000</li>
<li>
The new Metabolite patent obtained on Nov. 21 will expire on June 6, 2020</li>
</ul>
Meanwhile, the company is reported to have earned $2.6 billion from the
drug since 1986. Consumers pay over $700 million for the drug, which
is likely to drop in cost by up to 75% when generic forms are allowed on
the market. It is anticipated that Congress will be asked to review this
matter.
<p>Please respond to this email if you would like more information, or
would like to help us spread the word.
<p>Brad
<br>
<br>
<br>
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