Aurobindo Pharma Gets USFDA Approval For Generic Diovan HCT

Aurobindo Pharma has reported receiving final approval for the Valsartan and Hydrochlorothiazide tablets (brand name Diovan HCT held by Novartis). The drug is indicated in the treatment of hypertension to lower blood pressure. The market size of this drug is USD 1.7 billion (Rs 9350 crore) as per the company’s BSE filings. Aurobindo has said that the product is ready for launch and that this will happen soon.

Drug major Mylan has already launched an authorised generic version of this drug in USA. We believe that Aurobindo is the first to launch the generic of this drug considering that Mylan’s was an authorised generic.

We spoke to the company spokesperson, who declined to comment on the pricing and market share of the drug. However, he did say that the company expects to see about 3-4 generic players in the market. Considering this, about 20% market share looks achievable for Aurobindo. Since it is the first to launch, there would not be a massive erosion of price initially. However, as the drug has already fallen out of patent cover, new players would try to enter the market as faster as possible. Once other companies start launching their versions of the drug, the price will go down.

Considering 80% price erosion and 10% market share for Aurobindo, it can be estimated that the company may achieve revenues of about Rs 700 crore from the drug. Of course, these numbers are based on the assumption that the company makes the best of this opportunity.

With this approval, Aurobindo Pharma has a total of 181 ANDA approvals from USFDA, of which 156 are final and 25 are tentative approvals.