Tuesday, May 10, 2011

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.

0 Comments:

Post a Comment

<< Home