Lupin, Aurobindo Pharma launch generic Diovan in US

Novartis’s Diovan, the anti-hypertension drug, is the latest big generic drug opportunity for the Indian companies, industry observers said.

Diovan had a market of about $1.7 billion or Rs9, 238 crore in the 12-month period to September 2012.

Lupin and Aurobindo Pharma have confirmed receiving US regulatory approvals for the generic Diovan and would start selling the drug in the US market.

The companies would sell Valsartan and Hydrochlorothiazide (generic Diovan) tablets in 80mg/12.5mg, 160mg/ 12.5mg, 160mg/25mg, 320mg/ 12.5mg and 320mg/25mg dosage.

The drug helps lower blood pressure in patients not adequately controlled with monotherapy. It is also used in initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Lupin said it has already started shipping the product. “The product is ready for launch,” Aurobindo said in a statement.

Falling in the cardio-vascular therapeutic segment, generic Diovan is being seen as a major opportunity for the Indian companies.

“There were other companies from India that had tried for the US FDA (Food and Drug Administration) approval. However, some of them were not allowed to sell the drug as yet. For the companies that have already secured the approval, it should significantly contribute to the revenues. However, one has to wait for the price erosion as well, as that would eventually shrink the total market size,” said a source tracking the developments at Aurobindo.

@ ramanakv