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 drugmaker Mylan.
As reported on Pharmalot, Ranbaxy, the embattled generic drugmaker, 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.
Here is the press release from Mylan:
Mylan Launches First Generic Version of Diovan HCT® Tablets
-Company will have 180 days marketing exclusivity-
PITTSBURGH, Sept. 21, 2012 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. This product is the generic version of Novartis’ Diovan HCT® Tablets, which are indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.(1)
Mylan CEO Heather Bresch commented: “Mylan’s launch of the first generic Valsartan and Hydrochlorothiazide Tablets USP represents our eighth first-to-file launch this year, demonstrating our continued leadership in bringing new generic products to the market. Through this launch, we are proud to continue contributing to the increased health care savings experienced by patients, governments and payors in the U.S. supported by the generic availability of an important, widely prescribed product such as this one.”
Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg, had U.S. sales of approximately$1.6 billion for the 12 months ending June 30, 2012, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 168 ANDAs pending FDA approval representing $77.8 billion in annual sales, according to IMS Health. Thirty-three of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what’s right, not what’s easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don’t take our word for it. See for yourself. See inside. mylan.com
(1) Valsartan and Hydrochlorothiazide Tablets can cause injury and death to the developing fetus and therefore should be discontinued if pregnancy occurs. It should also not be used in people who are allergic to any component of the product or to other sulfonamide-derived drugs. Other precautions include: excessive reductions in blood pressure, decreased renal function, allergic reactions, exacerbation or activation of systemic lupus erythematosus, drug interactions with lithium, potassium and electrolyte abnormalities, visual changes and metabolic disturbances. If any of these conditions occur or are suspected, medical attention should be sought.
SOURCE Mylan Inc.