Glenmark, based in Mumbai, is seeking U.S. Food and Drug Administration approval for a generic version of the drug before Bayer’s patent expires in 2018, according to a complaint filed yesterday in federal court in Wilmington, Delaware.
Plaintiffs will suffer “irreparable harm for which they have no adequate remedy at law” unless Glenmark is prohibited from using the technology before the patent expires, Bayer said in court papers.
“Based on available information, Glenmark believes it may be a first applicant” to file for the generic version of Finacea “and may be entitled to 180 days of generic market exclusivity,” Glenmark said in a statement today.
Finacea had U.S. sales of about $95 million for the 12 months ending Sept. 30, according to data compiled by IMS Health, a provider of health-care information, Glenmark said.
The case is Intendis GMBH v. Glenmark Generics Ltd., 13-cv- 00421, U.S. District Court, District of Delaware (Wilmington).
To see the patent, click: 6,534,070.
To contact the reporter on this story: Dawn McCarty in Wilmington, Delaware, at email@example.com.