September 25th, 2012

Another One Bites the Dust: Diovan Patent Expires but Generic Valsartan Is MIA

Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drug maker Mylan.

As reported on Pharmalot, Ranbaxy, the embattled generic drug maker, holds the exclusive rights to market generic valsartan for 180 days, but has so far been unable to gain FDA approval. The delay, according to Pharmalot, “only adds to the uncertainty surrounding Ranbaxy’s ability to recover from its long-standing manufacturing woes and haggling with the FDA over its ability to resume operations on regular basis in the US.”

According to the Wall Street Journal, the Diovan franchise generated $5.7 billion worldwide in 2011.

One Response to “Another One Bites the Dust: Diovan Patent Expires but Generic Valsartan Is MIA”

  1. William DeMedio, MD says:

    If Ranbaxy is unable to deliver on its promise, isn’t the FDA within its rights to assign the job to any willing manufacturers who can? Ranbaxy is in breach of its contract with the FDA ie. The People of the United States and is possibly being paid by someone not to produce it. Something just does not smell right here.