Mumbai: Glenmark Pharmaceuticals Ltd has sued six US drug makers for violating its exclusive right to sell a cheaper version of skincare drug Locoid Lipocream in the US for six months.
The Mumbai-based company’s US arm Glenmark Generics Inc. got an approval last week from the US Food and Drug Administration to sell its copycat version of the skin drug, after it settled a case with the innovator Triax Pharmaceuticals Llc to launch it in the US with a six-month marketing exclusivity from December.
But it found that US drugmaker Metacon Labs had already launched a cheaper version of the drug authorized by Triax Pharma in the US market.
Glenmark Generics on Wednesday sued Triax Pharma and other group companies in a Delaware court seeking enforcement of its exclusive licence agreement with Triax Pharma, the company told the stock exchanges on Thursday.
The affiliate companies sued are US-based Astellas International, Astellas Pharma Europe BV,PreCision Dermatology Inc., Onset Dermatologics Llc and its authorized generic partner Metacon Labs.
“The agreement that Glenmark had signed with Triax Pharma, now a group company of Astellas, two years ago after it made a Para-4 filing in the US for this skincare drug, allows the company (Glenmark Generics) to launch the generic drug with an exclusivity for 180 days, and the company was planning to launch the same from December,” a Glenmark official said on Thursday.
“The agreement was part of settling the patent challenge case under the Para-4 filing with Triax, and it was agreed between the companies that the patent holder will not allow any authorized generic version of this drug in the US market before June 2014,” this official said.
Triax could not be contacted for comments immediately.
Glenmark said it is also seeking a temporary restraining order on the sale, manufacturing or marketing of generic equivalents of Locoid Lipocream by any of the defendants in violation of its exclusivity period.
Locoid Lipocream had sales of $34 million in the 12 months to end-June, according to data compiled by pharma market auditor IMS Health Inc.
Glenmark’s shares rose 2.83% to Rs586.70 on BSE, while the benchmark Sensex gained 0.12% to 20,272.91 points.