alleged infringement of patents covering methods of use of Takeda's colchicine product, Colcrys®. Since January 2015, Hikma has been marketing its own colchicine product under the brand name Mitigare™, as well as selling an authorised generic, increasing patient access to this important product in the United States. Said Darwazah, Chairman ...
Takeda loses again to Hikma in gout drug patent battle
2016年5月24日 · Takeda suffered a defeat in its battle to keep a competitor to its version of an ancient gout drug off the market. A federal court backed Hikma's right to sell a med with the same active...
Takeda Update Regarding Colcrys Litigation
2015年1月12日 · 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 …
Takeda Pharma., U.S.A. v. Hikma Am., Inc., No. 15-1139 ... - Justia Law
2015年5月6日 · Takeda has patents directed to treating acute gout flares and others directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors. In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares.
Takeda Update Regarding Colcrys® Litigation
2014年11月5日 · On October 6, Takeda filed a lawsuit against the FDA for violation of the Administrative Procedure Act (APA) for its approval of the Hikma Pharmaceuticals (“Hikma”) and West-Ward Pharmaceuticals (“West-Ward”) colchicine product. The APA allows parties to challenge improper actions by government agencies, such as the FDA.
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MEMORANDUM OPINION
Hikma has launched the accused product, Mitigare TM, an oral single-ingredient colchicine product, "indicated for prophylaxis of gout flares in adults" (D.I. 1, ex. Hat 1 ), and intends to launch a generic version of such at a price significantly below that of
Plaintiff Takeda Pharmaceuticals manufactures and markets Colcrys, a branded 0.6 mg colchicine tablet, for the treatment of gout prophylaxis and acute gout flares. In 2009, Colcrys became the only FDA-authorized colchicine product on the pharmaceutical market when the FDA removed all unauthorized colchicine products from the market.
Judge finds Hikma entitled to $31 mln in gout drug dispute
2018年12月14日 · Hikma Pharmaceuticals PLC did not infringe rival Takeda Pharmaceutical Co's patents by selling a gout drug with the same active ingredient as Takeda's Colcrys and is entitled to $31 million...
Hikma wins dismissal of Takeda patent lawsuit over gout drug
2016年5月20日 · A federal court has cleared the way for Hikma Pharmaceuticals Plc to continue selling a drug with the same active chemical as Takeda Pharmaceutical Co's gout drug Colcrys, dismissing a patent...
HIKMA wins Mitigare / Colchicine patent infringement case
2016年5月19日 · Since January 2015, Hikma has been marketing its own colchicine product under the brand name Mitigare™, as well as selling an authorised generic, increasing patient access to this important product in the United States.