Allos Therapeutics Sues Dr. Reddy’s Over Proposed Folotyn Generic
Colorado-based Allos Therapeutics and three research organizations are suing Dr. Reddy’s over its proposed generic version of the brand manufacturer’s orphan lymphoma drug Folotyn.
The four plaintiffs allege that Dr. Reddy’s Paragraph IV ANDA on Folotyn (pralatrexate) would infringe the drug’s ’071, ’470 and ’078 patents, according to the complaint filed July 7 in U.S. District Court for the District of New Jersey. The plaintiffs received notice of the Indian generics maker’s ANDA May 27, according to the complaint.
Allos holds the NDA on Folotyn. Non-profit corporations Sloan-Kettering Institute for Cancer Research, Southern Research Institute and SRI International own the drug’s patents, which they’ve licensed exclusively to Allos, the complaint said.
Folotyn was approved by the FDA in 2009 as the first drug to treat patients with relapsed or refractory peripheral T-cell lymphoma, a rare condition that the FDA estimates occurs in less than 9,500 patients in the U.S. each year.
Because of the rarity of the condition, the FDA granted the product orphan drug status to incentivize development of products that might not be financially viable otherwise. Orphan status gave Folotyn exclusive marketing for seven years, expiring September 2016.
The drug’s patents, however, last longer; both the ’470 and ’078 extend until 2025. Allos and the other plaintiffs want Dr. Reddy’s barred from any Folotyn generic at least until the patents expire, they said in their filing.
Dr. Reddy’s did not respond to a request for comment by press time. — Bryan Koenig
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.