Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) said that TPUSA will continue its patent-infringement litigation against Hikma Pharmaceuticals and its lawsuit against the US Food and Drug Administration (FDA) despite two recent court rulings that allowed Hikma to launch its colchicine product.

“We remain committed to pursuing our patent infringement lawsuit against Hikma,” said Kenneth D. Greisman, senior vice president and general counsel, Takeda Pharmaceuticals U.S.A., Inc., in a company statement. “We also believe that the FDA inappropriately approved Hikma's product and we will continue to challenge that approval.”

On January 9, 2015, the United States Court of Appeals for the Federal Circuit upheld an earlier decision by the United States District Court for the District of Delaware that affirmed the denial of Takeda's request for a preliminary injunction. The requested injunction would have prohibited the sale of Hikma's colchicine product during the pendency of Takeda's patent infringement litigation against Hikma. Colcrys (colchicine, USP) is sold by TPUSA and is protected by patents that extend through 2028 and 2029. A trial date in the patent case has not been set. Colcrys is a prescription medicine used in adults to prevent and treat gout flares.

Also on January 9, 2015, the United States District Court for the District of Columbia denied Takeda's request to overturn the FDA approval of Hikma's product. Takeda intends to appeal.

“Although the trial and appellate courts have not given Takeda preliminary relief, we remain confident that after a trial, Takeda will prevail,” Greisman said, in the statement.

In a company statement, Hiikma said it will now prepare to distribute its colchicine, which it will market under the brand name Mitigare. Hikma will also be preparing to launch an authorized generic of Mitigare. Sales of colchicine in the US market were approximately $688 million for the 12 months ending August 2014, according to IMS Health and reported by Hikma.

Separately, Prasco Laboratories has formed a pact with TPUSA a distribution and supply agreement for the rights to distribute colchicine tablets, USP, the authorized generic version of Colcrys (colchicine, USP) tablets in the US. Colchicine tablets (USP) will be marketed under the Prasco label and will be available in US pharmacies beginning later this week. Prasco is a privately held healthcare company located in Mason, Ohio, with an emphasis on authorized generics. Prasco  brought more than 65 authorized generic products to market since 2004, according to the company.

Source: Takeda (patent litigation), Takeda (authorized generic) and Hikma