Court allows generic colchicine to enter market



“At Takeda, we remain committed to providing patients with therapies that are safe, efficacious and meet high quality standards,” Douglas Cole, Takeda Pharmaceuticals President, said in a statement. “This new partnership will help enhance patient access to an important gout medicine by supplying Prasco with Colchicine Tablets, USP, manufactured under the same rigorous standards and processes as Colcrys.”

Prices for the Mitigare authorized generic and the Colcrys authorized generic have not been publicly announced. In an interview, West-Ward said it could not comment on exact savings to patients as savings will vary between insurance plans and pharmacy distribution channels.

“Our goal is to provide the most aggressive discounts on generic colchicine in the market with the intent for those discounts to be passed on to adult patients in need of treatment for the prophylaxis of gout flares,” Mr. Gavaris said.

At this article’s deadline, Takeda and Prasco had not responded to a question about the price of the generic Colcrys.

While rheumatologists expressed relief that generic colchicine products have finally become available, they also voiced concerns about potential barriers to access.

“I am proud of what the ACR did here and would hope that it serves as a model for future efforts by professional medical organizations to get into the (often legal) trenches and truly help their patients get affordable care. … [They] put their mouth where the money is and stood up for patients,” said Dr. Christopher M. Burns, a rheumatologist at the Geisel School of Medicine at Dartmouth College, Lebanon, N.H.

“I hope that this will, in fact, reduce the pricing for colchicine, and that it will not allow payers to add an onerous out-of-pocket cost for the drug far in excess of the cost if paid without utilizing pharmacy benefits,” said Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Dr. St.Clair added that the future availability and cost of generic colchicine is not certain given common supply-and-demand problems that can arise with generic drugs.

“We have observed critical shortages of several generic medications during the past several years that have drastically affected medical therapy for many common conditions,” he said in an interview. “We will need to keep a close eye on the supply of generic colchicine to ensure it keeps up with the demand. The FDA and the pharmaceutical industry has an obligation to ensure that patients have access to these critical generic drugs.”

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