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
TheStreet Open House

Watson Sues FDA Regarding Delay Of Generic Actos® Approval

PARSIPPANY, N.J., Aug. 15, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that it has filed suit against the U.S. Food and Drug Administration (FDA) challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets).  As a result of FDA's decision, Watson's abbreviated new drug application (ANDA) could be delayed for up to six months.  Watson noted that it filed suit after communications with FDA regarding its ANDA failed to resolve the dispute and permit a timely launch.  Watson maintains that FDA improperly denied the Company's shared exclusivity despite the Company directly following directions received from FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing.

Watson's suit will argue that the Company properly filed paragraph IV certifications to certain patents for Actos listed in the FDA Orange Book in its original 2003 ANDA filing. The FDA denied Watson's claim of shared exclusivity based on the timing of Watson's reinstatement of several of its original PIV patent certifications, which the company previously converted from a PIV to a section VIII at FDA's direction, and then reinstated back to a PIV patent certification following the settlement of patent litigation.

"When we learned of FDA's position regarding our application, we made efforts to work cooperatively with FDA to resolve the situation," said Paul Bisaro, Watson's President and CEO. "FDA has refused to grant shared exclusivity, and seeks to unnecessarily delay the launch of Watson's generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action.  We believe that we have sound arguments that refute FDA's position and will seek the court's intervention to enable approval."

Watson planned to launch its generic version of Actos ® on August 17, 2012, pursuant to a settlement agreement on March 10, 2010 with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America. Under pre-Medicare Modernization Act Hatch Waxman rules, Watson believes it is entitled to share in the 180 day period of generic marketing exclusivity. For the twelve months ending May 31, 2012, Actos® had total U.S. sales of approximately $2.7 billion according to IMS Health data.

Watson noted that in the event FDA fails to timely approve its ANDA for generic Actos, it remains confident that it can achieve its most recently disclosed forecast for full year 2012 due to a recent favorable update from the FDA related to another product and improved market conditions for certain products within the U.S. generics business.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,318.01 +52.02 0.30%
S&P 500 2,012.17 +0.81 0.04%
NASDAQ 4,579.5520 -13.8730 -0.30%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs