Forest-Janssen Sue Generic Players - Analyst Blog
March 16 2012 - 2:19PM
Zacks
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).
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis Report
WATSON PHARMA (WPI): Free Stock Analysis Report
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