Matthew Fay

Monday, January 12, marked the end of five years of high-priced gout medication, as 

Prasco Pharmaceuticals began shipping generic brands of colchicine

, in an agreement with Takeda Pharmaceuticals, manufacturers of the brand medication, Colcrys. 

within days a January 9 Federal Circuit Court decision 

 own generic brand of colchcine, Mitigare

This is expected to lower the price of the medication for gout flares, after a lengthy legal battle ended a six-year monopoly for the Colcrys brand. 

 of a traditionally good gout treatment gone bad:

. This gave URL Pharma, the company responsible for pre-approval testing, a 

 (as opposed to the usual 3), because the drug was 

approved not only for gout flares but also as an "orphan drug" for familial Mediterranean fever.

10 cents per (generic) pill to $5 per pill.

for $800 million, only to sell it to Sun Pharmaceutical a few months later, after acquiring ownership rights to Colcrys.
•   

2014:  FDA approved Hikma’s generic brand, Mitigare

 for breaking its exclusivity contract and obtained a Temporary Restraining Order against Hikma.
    

 lawyers for the American College of Rheumatology 

urging renewed approval for the release of Mitigare

. Its arguments included concern over the tendency of gout patients faced with exorbitant prices to discontinue treatment or to seek treatment from foreign countries.

nearly 30% of patients in the US take "risky and potentially dangerous steps" to save money on medications, such as skipping doses or skipping medication altogether.

 Patients with rheumatic diseases are especially at risk, said Mayo Clinic chair of rheumatology Eric Matteson MD, because they may become disabled as a result.

for persuading the court to annul the Takeda injunction and permit distribution of Mitigare, pending further litigation.

for why the voice of the medical community is a vital component to judicial proceedings that have the potential to affect the public’s access to care,” said ACR President William St. Clair in the press release.

prices for Mitigare and Takeda generic brand colchicine have not been announced publicly

. Although further appeals are possible, the Federal Circuit Court quickly denied Takeda's appeal for an immediate emergency injunction in response to the judgment.

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In court decision to approve generic colchicine for gout, American College of Rheumatology arguments about the risk to patients of exorbitant pricing may have played an important role. Is this a harbinger of something?

Author | Matthew Fay

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