Watson Barred From Generic Actos Market; Mylan, Teva, Ranbaxy May Enter First
This article was originally published in The Pink Sheet Daily
Executive Summary
Watson sues FDA, challenging the agency’s decision not to approve its ANDA for generic Actos while granting market exclusivity to other ANDA filers. The company planned to launch Aug. 17.
Watson Laboratories Inc. expected to share market exclusivity for generic Actos (pioglitazone) with Mylan NV, Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. But its plans were scuttled when FDA decided to delay approval of its ANDA until the 180-day exclusivity period ends while granting approval to other ANDA filers.
Watson filed suit against FDA on Aug. 15 seeking a declaratory judgment that FDA’s action is unlawful and an injunction to block FDA from granting final approval to any pioglitazone ANDA prior to approving Watson’s ANDA, or alternatively, to require FDA to grant final approval of Watson’s ANDA. The complaint, Watson v. Sebelius, was filed in the U.S. District Court for the District of Columbia.
Watson planned to launch its version of Takeda’s diabetes drug on Aug. 17. Watson had settled a patent infringement suit with TakedaPharmaceutical Co.Ltd. in 2010 under which it was granted a non-exclusive license to Actos composition and combination therapy patents as of Aug. 17. The complaint says Mylan and Ranbaxy entered into similar settlements with Takeda and were granted licenses to enter the market simultaneously with Watson. Watson also expected to share 180-day exclusivity with Teva, which had also been granted a license by Takeda.
“In August 2012, FDA informed Watson for the first time that approval for the Watson ANDA would be delayed,” the complaint states. “FDA informed Watson it had reached a decision to award another filer or filers a period of 180-day exclusivity, to the exclusion of Watson’s ANDA, and to delay approval of Watson’s ANDA until the expiration of that exclusivity period.”
Mylan stated at an investor meeting in February that it plans to launch generic Actos in August. Teva said it does not comment on launch plans and Ranbaxy could not be reached for comment.
Switch From Paragraph IV Certification May Be Factor In FDA’s Decision
Watson said it submitted an ANDA for generic pioglitazone on July 15, 2003 with Paragraph IV certifications that Actos’ composition and combination therapy patents were invalid, unenforceable or would not be infringed by Watson’s generic. The first applicant to file a substantially complete ANDA with a Paragraph IV certification is given a 180-day period to exclusively market the generic and simultaneous first filers share exclusivity.
The complaint says that at FDA’s request Watson changed Paragraph IV certifications related to the combination therapy patents to section viii statements, indicating that it would not seek approval for a use claimed in the patent. Following its settlement with Takeda, Watson amended its ANDA to reinstate these Paragraph IV certifications. The complaint says that “on information and belief,” Mylan and Ranbaxy also submitted amended ANDAs making or reinstating Paragraph IV certifications on the combination therapy patents after they settled with Takeda.
The complaint says FDA did not provide any explanation for its decision to delay approval of Watson’s ANDA.
“The FDA decision is contrary to the plain language of the FDCA [Food Drug, and Cosmetic Act], under which ANDA approval can only be delayed where another ANDA was previously filed with a Paragraph IV certification to the same patents,” the complaint states. “Additionally, to the extent that FDA’s decision is based on the determination that Watson has lost eligibility to exclusivity for the combination therapy patents, no other ANDA applicant is entitled to such exclusivity under FDA regulations and practice.”
Watson President and CEO Paul Bisaro said in a release that the company sought to work cooperatively with FDA to resolve the situation but that FDA refused to grant shared exclusivity.
Watson Expects To Meet Its 2012 Forecast
Watson noted in the release that for the 12 months ending May 31, Actos had U.S. sales of approximately $2.7 billion, according to IMS Health Inc. data.
The complaint argues that a delay in Watson’s entry into the pioglitazone market after the 180-day exclusivity period will cause it substantial and irreparable harm. It notes that Watson has made substantial investments in planning to launch on Aug. 17, including marketing, inventory, preparation of marketing and sales staff, and formulating market projections and a business plan.
In addition, the complaint says Watson would be able to maintain a significantly larger market share after the exclusivity period ends if it were granted shared marketing exclusivity. And if its entry is delayed, its competitors “will enjoy an opportunity to lock up relationships with key customers, putting Watson at a competitive disadvantage that will extend beyond the expiration of the unwarranted period of exclusivity.”
However, Watson downplayed the impact of a delay in market entry in its release. If FDA fails to timely approve its pioglitazone ANDA Watson “remains confident that it can achieve its most recently disclosed forecast for full year 20112 due to a recent favorable update from the FDA related to another product and improved market conditions for certain products within the U.S. generic business,” the release states.
Analyst Randall Stanicky, of Canaccord Genuity, said in a note that he did not expect a delay in approval of Watson’s generic Actos to have any meaningful impact since it would largely be contained to 2012 and heavy generic competition is expected after 180 days.