Fresh approvals for generic hypertension drug opens room for Indian firms

With fresh approvals coming in for generic valsartan (hypertension drug), Indian firms see a limited window of opportunity where they can have pricing power in the US market as the drug is in short supply due to multiple product recalls.
 
Sources revealed that the firms that got approval planned to launch the product in the US at the earliest. “Right now there is a shortage of the drug in the US and as a result there would be a pricing premium for the time being,” said an industry source.
 
The process used to make the drug was generating a carcinogenic substance as a byproduct. Companies that have got approval to sell the product use a different process. For those whose product had to be recalled, they have to either source the bulk drug or ingredient from a different supplier, or in case of captive bulk drug production, use a different process. After this, they have to seek a review by the US Food and Drug Adminis­tration (USFDA) for their product and process, subsequent to which they can launch their product in the market. “This would easily take up a few quarters, during which period it’s an opportunity for others,” said an industry source.

 
Earlier this month, Alkem and Cadila Healthcare (Zydus Cadila) received approvals from the USFDA for valsartan tablets that is used to treat high blood pressure. Firms such as Alembic and Jubilant were already selling the drug in the US market. Around August-September last year there were only a few players in the US market selling the hypertension drug.
 
Alembic, in fact, saw its international revenues increase 124 per cent year on year in the second quarter riding on this one-time supply opportunity.
 
“If Valsartan sales were taken out, then the US revenue growth would be over 20 per cent or so,” a senior company official had said.
 
Players such as Lupin and Zydus Cadila are backward integrated, which means they make their own API for most of their products. In September, USFDA had found the valsartan API of Lupin to be safe in its audit of the Tarapur facility. The company could thus, maintain its supplies of valsartan, losartan and irbesartan to the US.
 
Zydus, too, has a losartan product in the US. It has now got approval for a valsartan product that would be made at its Moraiya facility near Ahmedabad.
 
Looking to ease drug shortages triggered by multiple recalls of valsartan, the USFDA had sped up the review of the generic filed by Alkem Laboratories. In fact, outgoing FDA commissioner Scott Gottlieb has said recently that when faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients.