Ranbaxy settles with Takeda, is Japanese connection coming into picture?

Diachii-owned Ranbaxy has lately entered into a settlement agreement with the Japanese drug manufacturer Takeda Pharmaceuticals to end patent lawsuit for anti-diabetic drug Actos, generically known as Pioglitazone Hydrochloride. Under the terms of the agreement, Ranbaxy received non-exclusive royalty free license to Takeda’s patents covering Actos and will be able to launch the generic version in the US market on August 17, 2012. Interestingly, Ranbaxy seems to be getting business friendly with Japanese pharma companies, earlier it was Astellas for Flomax and now it is Takeda. No wonder if Japanese connection is coming into picture. Coming back to Actos, Takeda also signed similar sort of agreement with Watson to end patent lawsuits for Actos, allowing Watson to launch the generic version on August 17, 2012.

New Sources (1) the pharmaletter (2) the Economic Times

Para IV lawsuit against Mylan and Famy Care for OC pills

Teva has lately filed civil actions against the generic manufacturers Mylan and Mumbai-based Famy Care Limited for infringement of US Pat No. 7,320,969 and 7,615,545 listed with the OB for oral contraceptive (OC) pills Seasonique and LoSeasonique respectively. Both Seasonique and LoSeasonique are combination of Ethinylestradiol (estrogen) and Levonorgestrel differing only in dose amount, designed for 91 days regimen cycle with 84 consecutive combination pill days followed by 7 consecutive Ethinylestradiol pill days. In past, Teva sued Watson and Lupin for both Seasonique and LoSeasonique, with Watson having the First-to-File (FTF) state for Seasonique but not very clear which generic applicant is having FTF status for LoSeasonique. The lawsuits are filed in the US District Court District of New Jersey.

Does Ranbaxy intentionally forfeited 180-day exclusivity for monetary benefit?

Often strategic business moves are played within the closed walls of the Management Boardroom that can even take market analysts with surprise. Lately, Ranbaxy failed to launch its generic version of Flomax which was expected to go on sales in the US market on March 02 with 180-day market exclusivity. Ranbaxy in its statement reasoned regulatory delay in obtaining final approval for its failure to launch generic Flomax.

Flomax is marketed by Boehringer Ingelhiem in the US and its active ingredient, tamsulosin hydrochloride is protected by the US Patent No. 4,703,063 issued to Astellas Pharma Inc. Ranbaxy had “First-to-File” status for generic version of Flomax, with Impax Laboratories in paragraph IV race. Ranbaxy got sued by Boehringer and Astellas for patent infringement but in November 2007 announced out-of-the-court settlement that allowed Ranbaxy to launch its generic Flomax on March 02, 2010 i.e., eight weeks ahead of the expiration date of ‘063 patent. Similarly, Impax got sued for patent infringement and in October 2009 announced out-of-the-court settlement with Boehringer and Astellas interestingly having similar sort of arrangement (as that of Ranbaxy) that allowed Impax to launch its generic Flomax on March 02, 2010.

Now the question is when Astellas/Boehringer already entered into a settlement deal to allow FTF generic company Ranbaxy to launch its generic Flomax on March 02, 2010 knowing that the Ranbaxy also entitled to 180-day market exclusivity then how Astellas/Boehringer made similar sort of agreement with Impax to allow its generic Flomax launch on March 02, 2010? Does Ranbaxy which received tentative approval for its generic Flomax more than two-and-half years back (June 2007) seriously failed to obtain regulatory clearance despite settling patent dispute back in November 2007 with clear idea of launch date? Or does Ranbaxy made some strategic deal to allow Impax to launch its generic version on March 02, 2010? If yes, then with whom --- Astellas/Boehringer or Impax? Interestingly, a news piece by Livemint.com is suggesting that Ranbaxy may likely to receive one-time payment for enabling the launch of generic version in the US market, and also that Ranbaxy itself allowed Boehringer to bring in Impax for launching generic Flomax.