Taro settles patent suit, launches generic Trileptal
HAWTHORNE Taro announced Wednesday that it has settled a patent lawsuit with Novartis and will launch oxcarbazepine tablets, the generic version of Novartis’ Trileptal. Oxcarbazepine tablets are indicated to treat seizures.
The litigation with Novartis centered on Taro’s Paragraph IV certification challenging Novartis’ patent protection on Trileptal. On Nov. 15, 2007, Taro received Food and Drug Administration approval for its abbreviated new drug application for oxcarbazepine tablets in 150 mg, 300 mg and 600 mg strengths, but the company waited to launch the drug until the lawsuit was settled.
According to Taro, Trileptal currently has annual U.S. sales of approximately $700 million.
House investigates possibly misleading Lipitor advertisement
WASHINGTON Democrats in the House of Representatives are investigating as to whether or not consumers are being misled by advertisements for Lipitor featuring Dr. Robert Jarvik, the inventor of the artificial heart, the Associated Press reported.
Michigan Reps. John Dingell and Bart Stupak sent a letter to the drug’s manufacturer Pfizer on Monday, questioning the credibility of Jarvik, whom they believe is not certified to practice or prescribe medicine because he might not have taken the necessary tests or performed an internship.
Pfizer spokesman Chris Loder said Jarvik’s presence in the advertisements is meant to educate consumers on the importance heart health. “Dr. Jarvik is a respected health care professional and heart expert who knows how imperative it is for patients to do everything they can to keep their heart working well,” Loder said in a statement.
The representatives have requested that Pfizer turn over all of its information concerning Jarvik including its contract with him and any information about his professional qualifications.
Lipitor is the most prescribed drug in the U.S., with sales of $13.6 billion in 2006.
King ends five-year Skelaxin patent suit against CorePharma
BRISTOL, Tenn. & MIDDLESEX, N.J. King Pharmaceuticals has ended is patent lawsuit with CorePharma regarding its muscle relaxant drug Skelaxin and has signed an agreement with CorePharma related to the drug, according to Forbes.
On Jan. 2, the two companies signed an agreement under which, CorePharma will gain certain exclusive rights to Skelaxin 800 mg to market a generic version, called metaxalone and have also gained a non-exclusive license to produce and market a 400 mg version of the drug. This license will come into effect on Jan. 1, 2012.
Back in 2003, CorePharma was one of several biopharmaceutical companies to file with the Food and Drug Administration seeking permission to produce a generic. King countered by suing CorePharma and later Eon Labs and Mutual Pharmaceuticals, who also sought permission to produce a generic.
As of now, CorePharma is the only company that King Pharmaceuticals has an agreement with concerning Skelaxin. The drug is estimated to account for about $400 million in sales in 2008, according to Morgan Stanley.