Mylan vs. FDA (And Ranbaxy): Diovan Exclusivity Forfeiture Edition
This article was originally published in The Pink Sheet Daily
Executive Summary
In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.
Mylan Laboratories Ltd. is challenging FDA’s award of generic Diovan (valsartan) 180-day marketing exclusivity to Ranbaxy Laboratories Ltd., contending that Ranbaxy forfeited its exclusivity by failing to get timely tentative approval of its ANDA.
Mylan filed suit against the agency Oct. 2 requesting the court vacate FDA’s exclusivity award to Ranbaxy and require the agency to immediately grant final approval of its valsartan ANDA. Alternatively, the company asks for an interim injunction staying all approvals of valsartan ANDAs pending a resolution of the litigation. The complaint was filed in the U.S. District Court for the District of Columbia.
According to the complaint, Ranbaxy filed an ANDA on Dec. 28, 2004 and FDA granted the ANDA tentative approval on Oct. 25, 2007, four months after the 30-month tentative approval deadline.
Novartis Pharmaceuticals Corp.’s Diovan high blood pressure treatment is one of the biggest branded products to go off patent this year. Ranbaxy was expected to have sole 180-day marketing exclusivity for the single-ingredient valsartan but has yet to obtain final approval of its ANDA (Also see "Where’s Generic Diovan? Ranbaxy’s Valsartan ANDA In Limbo As Novartis’ Patent Expires" - Pink Sheet, 25 Sep, 2012.).
Mylan argues that Ranbaxy failed to secure tentative approval of its ANDA within 30 months of submitting the application, thus triggering forfeiture of exclusivity under the 2003 Medicare Modernization Act. The forfeiture applies unless the failure to obtain approval was caused by a change in, or a review of, approval requirements.
The complaint states that Mylan “did not discover anything that would have caused or indicated the presence of any changes in or review of the requirements for FDA approval of ANDAs referencing Diovan, or anything else that would have directly caused Ranbaxy to fail to meet the statutory deadline that would satisfy the forfeiture exception.”
FDA Cites Change In USP Monograph For Valsartan
The suit says FDA has not responded to Mylan’s requests for information about Ranbaxy’s apparent forfeiture. However, the complaint says that on Sept. 21, the agency for the first time made public its Oct. 25, 2007 letter to Ranbaxy granting the company’s ANDA tentative approval. In that letter FDA states that “there had been a ‘change’ to the USP monograph for valsartan published on May 1, 2007, and that the agency considered that monograph change to be a change in the requirements for approval imposed after the date on which Ranbaxy’s ANDA was filed,” the complaint says.
“FDA’s tentative approval letter to Mylan does not provide a detailed discussion – or, for that matter, any discussion – as to how the alleged change in or review of approval requirements caused Ranbaxy to miss (by many months) the 30-month statutory tentative approval deadline,” the complaint states.
Mylan contends that FDA has established a bright-line rule requiring that the issues holding up approval at the 30 month date be “causally connected” to approval requirements that FDA reviewed or changed. The complaint quotes a March 1 letter from FDA Center for Drug Evaluation and Research Director Janet Woodcock granting a citizen petition by Paddock Laboratories LLC The agency agreed with Paddock that Dr. Reddy's Laboratories Ltd. had forfeited its 180-day marketing exclusivity for generic versions of Antara (fenofibrate) because it failed to obtain tentative approval within the 30 month deadline.
FDA sent a Sept. 28 letter to Mylan granting tentative approval of its valsartan ANDA and stating that it would not be eligible for final approval until expiration of Ranbaxy’s 180-day exclusivity.
Mylan’s suit asserts that the agency’s “express refusal to timely and publicly disclose the basis for its determination that Ranbaxy has not forfeited its disclosure” and that Mylan is not entitled to final approval is in violation of the Food, Drug, and Cosmetic Act and the Administrative Procedure Act.
It further contends that “FDA’s decision to act without providing the required explanation appears strategically directed to avoid effective judicial review of final agency action.”
FDA Tackles Forfeiture Question In Lidocaine, Irbesartan ANDAs
FDA has been entangled in numerous disputes over 180-day exclusivity decisions. But Kurt Karst, of Hyman, Phelps & McNamara, notes on his FDA Law blog that Mylan is the first company to sue FDA over a decision involving forfeiture for failing to obtain timely tentative approval.
In another recent case involving the issue of forfeiture, the agency determined that Allergan PLC failed to obtain tentative approval of its ANDA for generic Lidoderm (lidocaine patch 5%) within 30 months. But in approving Watson’s ANDA, FDA said the company may be eligible for exclusivity, presumably because the approval was delayed by the time it took the agency to respond to citizen petitions, an exception to forfeiture included in the FDA Amendments Act of 2007 (Also see "Watson’s Generic Lidoderm Approval Leaves Questions About Exclusivity" - Pink Sheet, 3 Sep, 2012.).
Similarly, FDA concluded that Teva Pharmaceuticals USA Inc.’s generic version of Sanofi’s blood pressure drug Avapro (irbesartan) was eligible for exclusivity even though Teva did not obtain tentative approval of its ANDA within 30 months of the filing date because of review delays (Also see "Teva’s Generic Irbesartan Deserves 180-Day Exclusivity Because Of Review Delays, FDA Says" - Pink Sheet, 6 Apr, 2012.).
While Mylan is foreclosed from the market for single-ingredient valsartan it has 180-day marketing exclusivity for a generic version of Diovan HCT (valsartan and hydrochlorothiazide). Mylan launched the product on Sept. 21. Together Diovan and Diovan HCT had worldwide revenues of $5.67 billion in 2011.
This is the third time in the past 18 months that Mylan has sued FDA over its 180-day exclusivity decisions. Earlier this year, Mylan filed suit to overturn the agency’s decision granting Teva exclusivity for a generic version of Cephalon Inc.’s Provigil (modafinil). A district ruled in favor of FDA (Also see "No Need To Fight: Teva Retains Provigil Generic Exclusivity Even Without “Adversarial” Relationship" - Pink Sheet, 24 Apr, 2012.).
And last year Mylan sought a court order requiring FDA to announce whether Ranbaxy was eligible for 180-day exclusivity for a generic version of Pfizer Inc.’s Lipitor (atorvastatin). The court dismissed the suit saying Mylan lacked standing to sue until it obtained tentative approval of its atorvastatin ANDA (Also see "Lipitor Generics: Questions About Mylan's ANDA Weigh Heavily In Court's Dismissal Of Lawsuit Against FDA" - Pink Sheet, 3 May, 2011.).