Drug Company Sues FDA for Generic Diovan Rights

December 21, 2012

1115701_black_and_white_crime_2.jpgMylan, a generic drug maker is suing the FDA to force the agency to revoke Ranbaxy's sole rights to sell the generic alternative to Diovan, a blood pressure drug, and permit Mylan to start selling the drug. Our drug recall lawyers at Pintas & Mullins are closely following this development.

The patent for Novartis' drug Diovan expired in September of this year, when low cost generic varieties were expected to become available. However, to date there is still no generic substitute for the top-seller.

Ranbaxy, the generic drug manufacturer, is yet to get the green light from the FDA after securing the exclusive right to sell the drug for a preliminary six months. Mylan is a competing generic company that wants the FDA to revoke Ranbaxy's exclusive rights and permit it to sell the drug. Mylan is also exclusively selling a similar drug which is a blend of Diovan and a diuretic, though this drug's patent protection also ended in September.

The delay in the approval for generic Diovan is fortunate for Novartis considering that the drug brought in close to $2 billion in US sales in 2011.

For Ranbaxy, the delay is an additional problem because the drug manufacturer is operating under a federal consent decree. Last month, it recalled over 40 lots of generic Lipitor after discovering glass particle contamination.

Ranbaxy is now under intense scrutiny from the FDA because of quality lapses identified at numerous factories over the last few years.

An FDA spokeswoman refused to comment both on why the agency didn't approve Valsartan, Ranbaxy's generic Diovan and on Mylan's lawsuit.

As per federal law, the first company to effectively challenge a patent and prove that it can manufacture a drug is awarded a six-month exclusivity period that is valued highly in the world of generics. However, the law also demands that those companies get FDA approval within 30 months. In this particular instance, Ranbaxy received approval four months after the deadline.

The FDA offers exceptions to the 30-month rule if requirements or procedures change considerably after a drug manufacturer files its application. With respect to Ranbaxy, the rules for making Diovan did change during that period.

Mylan has a litigious history with Ranbaxy and other pharmaceutical comapnies. Last year, the company unsuccessfully questioned Ranbaxy's right to be the sole seller of generic Lipitor on the basis of prior manufacturing breaches. This year, Mylan sued Teva over its right to be the sole provider of a generic anti-drowsiness drug called Provigil.

Reports of drugs intended to improve quality of life with serious, life-threatening complications continue to rise. A recent HealthDay article revealed that SSRI (Selective Serotonin Reuptake Inhibitors) anti-depressants such as Paxil, Zoloft, Prozoc and Celexa may increase the risk for considerable bleeding in patients who also take Warfarin, a blood thinner.

For decades, doctors have been prescribing Warfarin to aid in stroke prevention. A former resident physician in internal medicine said that smaller and less meticulous studies have shown that SSRI antidepressants could interact with Warfarin, thereby increasing bleeding risks. However, those studies did not consider other factors such as a patient's degree of illness or age.

In the new study, the former resident physician and his colleagues considered the above factors while looking at information from a continuing study of over 13,000 people with atrial fibrillation (irregular heartbeat). Close to 9,200 of these individuals were also taking Warfarin, and were the focus of the novel study.

The Warfarin users were grouped into three cohorts - those who weren't using antidepressants, those who were using SSRIs, and those using tricyclic antidepressants.

A comparison of the bleeding risk of the three groups revealed the risk of serious hemorrhage was 60% higher for patients using the combination of Warfarin and SSRIs than that for those not taking an SSRI.

There was no statistically significant difference in risk in the case of those taking Warfarin and tricyclic antidepressants. In other words, the effect applied to SSRIs alone and not to all antidepressants.

If you or a loved one suffered bleeding issues which you suspect was caused by the interaction of Warfarin and SSRIs, talk to a drug recall attorney about receiving potential compensation.