Two generics manufacturers have settled patent litigation over their abbreviated new drug applications for oxcarbazepine, the active ingredient in Swiss giant Novartis AG's popular anti-epileptic Trileptal, permitting both to sell tablets in the U.S. immediately
Taro Pharma (reported earlier in this blog) and Breckenridge have settled their lawsuit with innovator Novartis
Breckenridge Pharmaceutical, Inc. announced today that it settled "Paragraph IV" litigation with Novartis concerning Trileptal(R) and that the USFDA approved Breckenridge's Abbreviated New Drug Application for oxcarbazepine 150mg, 300mg and 600 mg tablets in the United States ("Oxcarbazepine Tablets").
Breckenridge enjoys a shared 180-day exclusivity period with Taro and will immediately launch Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. Oxcarbazepine Tablets are AB rated to Trileptal(R), a $600 million brand name drug marketed by Novartis Pharmaceuticals Corporation, and are used in treating seizures.
Taro Pharma (reported earlier in this blog) and Breckenridge have settled their lawsuit with innovator Novartis
Breckenridge Pharmaceutical, Inc. announced today that it settled "Paragraph IV" litigation with Novartis concerning Trileptal(R) and that the USFDA approved Breckenridge's Abbreviated New Drug Application for oxcarbazepine 150mg, 300mg and 600 mg tablets in the United States ("Oxcarbazepine Tablets").
Breckenridge enjoys a shared 180-day exclusivity period with Taro and will immediately launch Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. Oxcarbazepine Tablets are AB rated to Trileptal(R), a $600 million brand name drug marketed by Novartis Pharmaceuticals Corporation, and are used in treating seizures.
No comments:
Post a Comment