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Court allows generic colchicine to enter market


 

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After a 5-year monopoly on the sale of colchicine put the gout medication out of reach for many patients, a federal judge in January denied an injunction request by Takeda Pharmaceuticals U.S.A. to halt the distribution of colchicine products by Hikma Pharmaceuticals PLC.

The availability of a generic colchicine will introduce competition into the marketplace and drive down costs, said Dr. E. William St.Clair, president of the American College of Rheumatology and chief of the division of rheumatology and immunology at Duke University, Durham, N.C. The ACR issued a friend-of-the-court brief to the federal district court in support of a generic colchicine product entering the market.

Dr. E. William St.Clair

Dr. E. William St.Clair

“With the steep price increase in colchicine, many patients with gout were now unable to afford chronic colchicine therapy,” Dr. St.Clair said in an interview. “Improving access to colchicine by making it more affordable will increase patient compliance and reduce the suffering and disability associated with repeated gout flares.”

The debate over colchicine and the right to market the medication has a lengthy history. The drug has been prescribed to treat gout for decades, predating the law that requires drugs to be approved by the Food and Drug Administration. In 2009, the FDA approved a brand name colchicine product (Colcrys) by Mutual Pharmaceutical Company/URL Pharmacy Inc. – now Takeda Pharmaceuticals U.S.A. – after the company conducted clinical trials on dosing regimens and performed drug interaction studies. The FDA’s approval of Colcrys came with exclusive marketing rights for gout for 3 years and for familial Mediterranean fever for 7 years.

Mutual Pharmaceutical Company then sued other manufacturers of colchicine, claiming the drug makers were falsely implying that their products were FDA approved. Shortly later, the FDA ordered companies marketing single-ingredient oral colchicine to remove their unapproved products from the market. Physicians and patients meanwhile saw the price of colchicine increase from about 10 cents per tablet to $5 per tablet.

In September 2014, the FDA granted approval for Hikma to market and sell Mitigare, a colchicine capsule for the prophylactic treatment of gout. Hikma had also planned to launch an authorized generic of Mitigare. Before Mitigare could fully launch, Takeda obtained a temporary restraining order against the sale of colchicine products by Hikma, citing Takeda’s patents for acute gout treatment. Takeda simultaneously sued the FDA in a separate proceeding. Takeda said the FDA’s approval of Hikma’s colchicine product was legally impermissible.

In its brief to the federal court, the ACR argued the public interest would be severely disserved by the barring of Hikma’s colchicine product.

“The unfortunate reality is that nearly 30% of patients in the United States take risky and potentially dangerous steps to save money on prescription medicines, with many choosing to skip doses, or not fill their prescriptions altogether,” the ACR said in its brief. “Takeda’s monopoly and the associated price increase for colchicine has resulted in precisely the sorts of risky behavior described.”

A lower court denied Takeda’s preliminary injunction request and the decision was upheld by the U.S. Court of Appeals for the Federal Circuit on Jan. 9. Pending the outcome of further litigation, the federal court ruled that both Takeda and Hikma are free to immediately offer colchicine products for prophylactic use. Also on Jan. 9, the U.S. District Court for the District of Columbia denied Takeda’s request to overturn the FDA’s approval of Mitigare.

In an interview, a Takeda spokeswoman said the company will continue its patent infringement litigation against Hikma and its U.S. subsidiary, West-Ward Pharmaceuticals, along with its lawsuit against the FDA. The company offered no comment on the judge’s decision to deny the injunction.

West-Ward, meanwhile, launched its authorized generic to Mitigare following the judge’s Jan. 9 decision, and Mitigare’s entry to the market was resumed.

“We immediately sought to launch a generic of Mitigare to ensure that adult patients in need of treatment for the prophylaxis of gout flares had access to a lower-cost, alternative colchicine capsule product,” said Spiro Gavaris, vice president of sales and marketing for West-Ward Pharmaceuticals. “We understood that in recent years, some patients may have lost access to, or became frustrated with, colchicine when there was one brand product at a significantly higher price point. With our launch of the authorized generic of Mitigare capsules, doctors can now choose to prescribe Mitigare for the prophylaxis of gout flares in adults, thereby providing these patients with a lower cost generic medication.”

Days after the decision, Takeda announced that it also would be offering access to a generic colchicine. In a statement, the company said it would partner with Prasco Laboratories to distribute Colchicine Tablets, USP, an authorized generic version of Colcrys. The product is being marketed under the Prasco label and became available in U.S. pharmacies in mid-January.

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