In a statement, the company said it would partner with Prasco Laboratories to distribute Colchicine Tablets, USP, an authorized generic version of Colcrys
According to the contract, Colchicine Tablets, USP will be the only colchicine product on the market that is therapeutically equivalent and automatically substitutable for prescriptions written for Colcrys
The addition of URL Pharmaa[euro](tm)s Colcrys
to Takedaa[euro](tm)s products will allow the Japanese firm to provide multiple treatment options for the management of acute and chronic gout in the US, where the prevalence of this disease, affecting some eight million people, is growing, Douglas Cole, Takeda Pharmaceuticals USA Inca[euro](tm)s president, said.
Introducing an Authorized Generic of Colcrys
provides patients, pharmacists, and physicians with access to a therapeutically equivalent option to Colcrys
Tablets for the prevention and treatment of gout flares, stated Prasco chief executive officer, Chris Arington.
came out, and the old cheap colchicine went bye-bye, she tried going with allopurinol alone because of the shocking price of Colcrys
Once the older products are off the market, the only oral colchicine product that will be available is Colcrys
, marketed by Mutual Pharmaceuticals/URL Pharma, which was approved in 2009, after the company met the current drug approval requirements.
com/research/cc5711/gout_therapeutics) has announced the addition of the "Gout Therapeutics Market to 2017- Entry of Novel Therapies such as Krystexxa, Uloric, Adenuric and Colcrys
to Drive Market" report to their offering.
from the gout drugs that came over with last year's URL Pharma purchase, Uloric and Colcrys
But in October 2009, the Food and Drug Administration awarded a patent to URL Pharma (now owned by drug giant Takeda) for a branded formulation of colchicine, Colcrys
, to treat gout on the basis of safety studies that URL funded.
According to its product label, Colcrys
is "'colchicine, USR" The claim by Mutual/URL that its colchicine, USP is safer than other colchicine, USP is based on its product label, which includes a lower dosing regimen for acute gout and information on drug interaction studies.
In light of the FDA's removal of unapproved colchicine from the market, [these outlying companies] must follow the lead of other Part-D insurers around the country and reclassify COLCRYS
as a tier-1 or 2 drug to ensure seniors have access to their vital gout medications" Martin wrote to the CEOs of the companies.
Its lead product Colcrys
, used to treat and prevent gout flares, had sales of more than $430 million for that year.
50) urged that unapproved, illegally marketed colchicine products remain on the market alongside Colcrys
, the only colchicine approved by the Food and Drug Administration.
URL Pharma performed a clinical trial comparing two dosing regimens for acute gout, did some drug interaction studies in normal volunteers, and branded their previously generic/"unapproved" colchicine product as Colcrys
have entered into an agreement in which Colcrys
(colchicine tablets USP) are being marketed as an authorized generic under the Prasco label.