Forest-Janssen Sue Generic Players - Analyst Blog

By
A A A

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
 
To read this article on Zacks.com click here.
 
Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: FRX , IRWD , JNJ , MYL , TEVA

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Stocks

Referenced

Most Active by Volume

33,974,386
  • $17.98 ▲ 0.28%
20,763,901
  • $91.29 ▲ 2.06%
19,110,793
  • $7.26 ▼ 1.22%
18,528,869
    $8.33 unch
18,014,920
  • $4.19 ▼ 1.18%
16,448,919
  • $25.83 ▼ 0.19%
14,748,190
  • $7.60 ▼ 1.43%
14,144,383
  • $112.01 ▼ 0.47%
As of 12/24/2014, 02:12 PM


Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com