Generics Firms Jump on Creating Versions of Novartis’ Diovan

Ranbaxy’s 180-day marketing exclusivity period for its version of Novartis’ blockbuster hypertension drug Diovan ended, prompting a flood of generic competition.

Mylan and Lupin both said they had launched the product, and Jubilant Life Sciences said the FDA had granted it approval and it planned to launch immediately. Branded Diovan (valsartan) generated roughly $2 billion in annual sales, the firms said citing IMS Health data.

Ranbaxy launched its version of Diovan this summer following a two-year delay caused by FDA findings of poor manufacturing quality at one of its plants. The company held onto its exclusivity despite challenges from Mylan and law firm Hyman, Phelps & McNamara that had argued the company should lose its first-filer rights because of the violations. — Bryan Koenig