Watson Sues FDA Regarding Delay of Generic Actos® Approval
PARSIPPANY, N.J., Aug. 15, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (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.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing 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.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the inherent uncertainty associated with financial projections; the inherent uncertainty of litigation, including the litigation against the FDA concerning Watson's ANDA for its pioglitazone product, and risks that Watson will not prevail in such litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' and service providers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 and Watson's Annual Report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Actos(R) is a registered trademark of Takeda Chemical Industries, Ltd.