Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Enters Into Asset Purchase Agreement with Forest Laboratories, Inc. to Settle Lexapro(R) (escitalopram oxalate) ANDA Patent Litigation
Date:7/10/2009

DETROIT, July 10 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) announced that, as part of the settlement of the legal proceedings related to Lexapro(R) (escitalopram oxalate) tablets, it entered into an Asset Purchase Agreement with Forest Laboratories, Inc. ("Forest") to acquire several products from Forest's Inwood line of business. The ANDA patent litigation settlement resolves litigation involving Caraco, Forest, Forest Holdings, Ltd., and H. Lundbeck A/S and Sun Pharmaceutical Industries Limited ("Sun"). Caraco is a subsidiary of Sun.

Among other things, with respect to Caraco, the litigation settlement involves the following provisions:

1. Forest has agreed to provide licenses to Caraco for any patents related to Lexapro(R) with respect to the marketing of Caraco's generic version of the product as of the date that any third party generic enters the market with final approval from the FDA other than an authorized generic or the first filer with Hatch-Waxman related exclusivity.

2. Forest will reimburse Caraco for a portion of its attorney's fees related to this litigation.

3. Pursuant to the Asset Purchase Agreement (the "APA"), Caraco will take over the commercialization and sale of several products from Forest's Inwood business. Caraco will pay Forest an advance against royalties and royalties on net sales of these products.

The terms of the settlement will be submitted to the Federal Trade Commission and the Department of Justice pursuant to the Medicare Modernization Act. The APA is scheduled to close no sooner than 40 days after the signing, which the parties hope will provide the FTC and DOJ with sufficient time to review the transaction. As the transaction must be submitted to the FTC and DOJ, there is a possibility that the transaction may need to either be revised, or it may not be consummated, and the litigation would be re-instituted.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on a few products generating a majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.


'/>"/>
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Announces an Indefinite Reduction in its Workforce
2. Caraco Pharmaceutical Laboratories, Ltd. Updates on Financial Position
3. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Action
4. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Fiscal Year 2009, Updates on FDA Inspection
5. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Roxicodone(R) Tablets
6. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax(R) Tablets
7. Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
8. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009
9. Caraco Pharmaceutical Laboratories, Ltd. to Announce Third Quarter of Fiscal Year 2009 Results on January 29, 2009
10. Caraco Pharmaceutical Laboratories, Ltd. Responds to FDA Warning Letter
11. Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... , ... October 13, 2017 , ... ... serving communities in the greater Dallas, Miami, and Raleigh regions, is organizing an ... to overcome a rare and deadly chromosome abnormality. , After struggling since birth ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The American Board ... become its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon ... beginning July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... a national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel ... also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... ... 2017 , ... Coveros, a leader in agile coaching services ... by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile Transformation ... Agile methodologies in a consistent and high value manner across CMS programs. Coveros ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... 2017  As the latest Obamacare repeal effort moves ... (R-LA) and Lindsey Graham (R-SC) medical ... device industry is in an odd place.  The industry ... excise tax on medical device sales passed along with ... patients, increased visits and hospital customers with the funding ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017  PMD ... OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... strategic hub service that expedites and streamlines patient and ... Spiro PD 2.0, and wellness management services.  ... medical device used to measure lung function for a ...
(Date:9/12/2017)... -- Consumer reviews on the independent review site Consumer Affairs ... for hearing aids, ranking it higher than Miracle Ear ™, ... ... Hearing Aids ... store that provides high performance, state-of-the-art, German-engineered hearing aids directly to ...
Breaking Medicine Technology: