As Launch Date Nears, Is Ranbaxy Exploring Talks To Monetize Lipitor First-launch Opportunity With Generic Rivals?

MUMBAI - As Ranbaxy struggles to deal with U.S. FDA allegations of GMP violations and data falsification at its two Indian manufacturing sites - Paonta Sahib and Dewas - clouds are gathering over its ability to launch a generic equivalent of the planet's largest drug brand Lipitor (atorvastatin) in the United States, about a year from now.

A June 2008 patent settlement between Pfizer and Ranbaxy delayed the launch of a generic equivalent of Lipitor until November 2011 - helping the U.S. drug giant keep its exclusive rights over the nearly $11 billion brand for 20 months beyond the expiration of certain patents (Also see "Pfizer Stalls Generic Lipitor With Ranbaxy Deal" - Pink Sheet, 18 Jun, 2008.).

However, with no resolution in sight to the five-year-long impasse that has effectively crippled Ranbaxy's U.S. operations owing to an FDA-ordered ban on 30 products, some India analysts are speculating that Ranbaxy - now part of Japanese firm Daiichi Sankyo - may be looking to monetize its ANDA filings for atorvastatin if it cannot gain permission to launch by Nov. 30, 2011.

In December 2009, Ranbaxy was said to have moved its ANDA filings for atorvastatin to its U.S.-based Ohm Labs site, but apart from noting that it will defend its first-to-file status for all drugs, Ranbaxy did not confirm that alternatives are being explored for atorvastatin (Also see "Ranbaxy Transfers Atorvastatin, Tamsulosin Filings To Ohm Labs While Valacyclovir Rakes Big Gains" - Scrip, 8 Dec, 2009.).

"Ranbaxy may not want to jeopardize it chances of making money from its biggest revenue opportunity. It is therefore likely that the firm is talking to competition to take a respectable part of the cash that may start flowing late next year," a senior analyst with a well-known Japanese brokerage firm told PharmAsia News.

A Ranbaxy spokesperson declined to comment about the status of its atorvastatin filings or negotiations with other generic firms.

Down This Road Before?

If Ranbaxy plans to give up the atorvastatin opportunity, it would be the second time the firm has made such a move. In March, Ranbaxy allowed Impax to launch its generic version of Flomax (tamsulosin) as it could not gain required approvals in time from FDA. At the time, Ranbaxy made sure to say that its earlier patent dispute settlement with innovator Boehringer Ingelheim "did enable the entry of an alternate generic that would benefit the consumers."

Notably, Watson has secured "authorized generic" status for atorvastatin from Pfizer and can launch its generic version on November 30, 2011, under the terms of a five-year deal. However, firms such as Teva, Mylan, Dr. Reddy's and Apotex are seen by Indian analysts as big contenders for the atorvastatin market in the U.S. although the status of their tentative approvals are hard to identify.

"Even a small part of the multi-billion dollar atorvastatin market, could change the fortunes of generic firms," another analyst agreed.

Through litigation against Pfizer, Apotex has been aggressively pursuing an early launch of atorvastatin in the U.S. market, noting in part Ranbaxy's failure to get products approved by U.S regulators (Also see "Lipitor Patent Battle: Pfizer Plots New Course In Suit With Apotex" - Pink Sheet, 2 Aug, 2010.)

In August, Ranbaxy's former CEO Atul Sobti expressed hope to investors that the company is close to a "final resolution" of pending GMP issues following submission of a corrective action plan to FDA. Some analysts believe that Ranbaxy will need to enter into a consent decree with FDA, including a disgorgement penalty, to solve the dispute (Also see "Ranbaxy May Be Hit With Significant Disgorgement Penalty For GMP Violations" - Scrip, 27 Aug, 2010.)

- Vikas Dandekar ([email protected])