Lupin launches HIV drug in US after FDA approval
In short
Lupin has launched Raltegravir Tablets USP, 600 mg, in the US after getting FDA approval. The company is the first to file the generic version of Merck’s Isentress HD and can qualify for 180-day generic exclusivity.
This may help Lupin get a temporary sales advantage in the US market. The reporting does not say how much money it will make or when the exclusivity period starts.
What the reporting says
Lupin launched Raltegravir Tablets USP, 600 mg, in the US after FDA approval and gained eligibility for 180-day generic exclusivity, according to the publisher summary. It is the exclusive first-to-file generic for Merck’s Isentress HD. The immediate consequence is a potentially protected launch window, while the reporting does not state the exact start date or revenue impact for Lupin.
Why it matters
Lupin has launched Raltegravir Tablets USP, 600 mg, in the US after FDA approval, according to the publisher summary. It is the exclusive first-to-file for the generic version of Merck’s Isentress HD and is eligible for 180-day generic exclusivity. That could support a short-term commercial advantage in the US generics market, though the reporting does not give launch timing details or sales guidance beyond the cited $26 million estimate for the product.