Forest Laboratories, Inc. (FRX) and Janssen Pharmaceutica NV, a Johnson & Johnson (JNJ) company, recently filed a joint lawsuit against several generic companies that are looking to launch their generic versions of Bystolic (nebivolol).
The patent infringement lawsuit has been filed in the US District Court for the District of Delaware for infringement of US Patent No. 6,545,040. The lawsuit has been filed against companies like Amerigen Pharmaceuticals, Inc., Glenmark Generics, Inc., Hetero USA Inc., Torrent Pharmaceuticals Ltd., Watson Laboratories, Inc. (WPI).
Another patent infringement lawsuit has been filed by Forest Labs and Janssen in the US District Court for the Northern District of Illinois against Alkem Laboratories Limited and Indchemie Health Specialties Pvt. Ltd. This lawsuit is also related to the infringement of the ‘040 patent.
With the lawsuits being filed within 45 days of receipt of notice from the generic companies, the FDA cannot grant final approval to the generic versions for up to 30 months.
Bystolic is a beta-blocker indicated for the treatment of hypertension. Bystolic sales came in at $250.9 million, up 31.2% from the year-ago period, in the first nine months of fiscal 2012. Forest Labs has in-licensed the ‘040 patent from Janssen. The patent is scheduled to expire in December 2021, including patent term extension.
Neutral on Forest Labs
We currently have a Neutral recommendation on Forest Labs, which carries a Zacks #3 Rank (short-term Hold rating). The company is currently facing a major patent cliff with Lexapro, its key revenue generator, losing patent exclusivity recently. While Teva (TEVA) launched its generic version of Lexapro recently, Mylan (MYL) is marketing an authorized generic version of the product.
Another key product, Namenda, in Forest Labs’ portfolio could start facing generic competition in early 2015. To reduce the impact of genericization, Forest Labs has been working on developing its pipeline. The company has two important FDA action dates coming up in the second quarter of 2012. While linaclotide (partnered with Ironwood Pharmaceuticals (IRWD)) is under review for the treatment of constipation-predominant irritable bowel syndrome and chronic constipation, aclidinium (partnered with Almirall) is under regulatory review for chronic obstructive pulmonary disease (COPD).
Meanwhile, Forest Labs expects to file two more new drug applications (NDAs) in the second half of 2012 (levomilnacipran and cariprazine).
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