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Lupin Receives Tentative USFDA Approval for Generic Raltegravir Tablets

• Lupin has received tentative approval from the USFDA for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg, a generic version of Merck's Isentress HD. • Lupin is the exclusive first-to-file for this product, potentially granting them 180-day exclusivity in the market. • Raltegravir Tablets are indicated for use in combination with other antiretroviral agents for treating HIV-1 infection in adults and pediatric patients weighing at least 40 kg. • The annual sales for Raltegravir Tablets USP, 600 mg (RLD Isentress HD) in the U.S. market were approximately USD 36 million as of September 2024.

Lupin Limited has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. This approval paves the way for Lupin to market a generic equivalent of Merck Sharp & Dohme's Isentress HD Tablets, 600 mg, used in the treatment of HIV-1 infection.
Lupin's First-to-File Status
Notably, Lupin holds the distinction of being the exclusive first-to-file for this generic product. This status potentially grants Lupin a 180-day exclusivity period, providing a significant market advantage upon final approval and launch.
Manufacturing and Indication
The Raltegravir tablets will be manufactured at Lupin’s facility located in Nagpur, India. The tablets are indicated for use in combination with other antiretroviral medications in both adult and pediatric patients (weighing at least 40 kg) infected with HIV-1.
Market Context
According to IQVIA data, the annual sales for Raltegravir Tablets USP, 600 mg (reference listed drug Isentress HD) reached approximately USD 36 million in the U.S. market as of September 2024. The introduction of a generic alternative by Lupin is expected to provide a more cost-effective treatment option for patients.
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Reference News

[1]
Lupin receives tentative approval from USFDA for Raltegravir Tablets - Indian Pharma Post
indianpharmapost.com · Nov 9, 2024

Lupin receives tentative USFDA approval for Raltegravir Tablets, 600 mg, a generic equivalent of Merck's Isentress HD, t...

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