Colchicine patent wars?
There is current litigation in District of New Jersey over US 7,601,758 , titled Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares , with first claim
A method of using colchicine to treat a gout flare in a human patient who is receiving concomitant administration of clarithromycin or erythromycin, said method comprising: determining a first colchicine dosage amount adapted for oral administration to the patient to treat a gout flare in the absence of concomitant administration of clarithromycin or erythromycin, determining a second colchicine dosage amount that is about a two thirds reduction of the first colchicine dosage amount, orally administering the second colchicine dosage amount to the patient who is experiencing a gout flare and is concomitantly receiving administration of clarithromycin or erythromycin, wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount, and not repeating colchicine administration for at least three days. .
Colchicine is used for gout despite dosing issues concerning its toxicity. Wikipedia notes:
On July 29, 2009 U.S. Food and Drug Administration (FDA) approved colchicine as a monotherapy for the treatment of familial Mediterranean fever and acute gout flares,[2] and gave 7-year marketing exclusivity[3] to URL Pharma, in exchange for URL Pharma doing 2 new studies. URL Pharma raised the price from $0.09 per pill to $4.85, and sued to remove other versions from market.
The written description of colchicum for gout goes back to 1500 B.C. Wikipedia also notes: Colchicum was brought to America by Benjamin Franklin; Franklin suffered from gout himself.
Cross-reference:
KV Pharma's Makena ( 17P ) :
The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and the pharmaceutical company has backpedaled on its pricing.
A method of using colchicine to treat a gout flare in a human patient who is receiving concomitant administration of clarithromycin or erythromycin, said method comprising: determining a first colchicine dosage amount adapted for oral administration to the patient to treat a gout flare in the absence of concomitant administration of clarithromycin or erythromycin, determining a second colchicine dosage amount that is about a two thirds reduction of the first colchicine dosage amount, orally administering the second colchicine dosage amount to the patient who is experiencing a gout flare and is concomitantly receiving administration of clarithromycin or erythromycin, wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount, and not repeating colchicine administration for at least three days. .
Colchicine is used for gout despite dosing issues concerning its toxicity. Wikipedia notes:
On July 29, 2009 U.S. Food and Drug Administration (FDA) approved colchicine as a monotherapy for the treatment of familial Mediterranean fever and acute gout flares,[2] and gave 7-year marketing exclusivity[3] to URL Pharma, in exchange for URL Pharma doing 2 new studies. URL Pharma raised the price from $0.09 per pill to $4.85, and sued to remove other versions from market.
The written description of colchicum for gout goes back to 1500 B.C. Wikipedia also notes: Colchicum was brought to America by Benjamin Franklin; Franklin suffered from gout himself.
Cross-reference:
KV Pharma's Makena ( 17P ) :
The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and the pharmaceutical company has backpedaled on its pricing.
posted by Lawrence B. Ebert at 7:25 AM
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