This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Watson Confirms Atelvia(TM) Patent Challenge

PARSIPPANY, N.J., Oct. 17, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Risedronate Sodium Delayed-release Tablets, 35 mg.  Watson's Risedronate Sodium Delayed-release Tablets are a generic version of Warner Chilcott (US), LLC's Atelvia(TM) delayed-release tablets. Atelvia(TM) is indicated for the treatment of postmenopausal osteoporosis.

(Logo:   http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)

Warner Chilcott (US), LLC and Warner Chilcott Company, LLC filed suit against Watson on October 12, 2011 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 7,645,459 and 7,645,460. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date that Warner Chilcott received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Atelvia(TM) and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending August 31, 2011, Atelvia(TM) had total U.S. sales of approximately $17 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,095.72 +71.66 0.40%
S&P 500 2,117.44 +9.15 0.43%
NASDAQ 5,030.9260 +25.5350 0.51%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs