Lupin has launched Raltegravir Tablets USP, 600 mg, in the US following approval of its Abbreviated New Drug Application (ANDA) by the US Food and Drug Administration (FDA).
The tablets are bioequivalent to Merck Sharp and Dohme’s reference listed drug (RLD), Isentress HD Tablets, 600 mg. They are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients and paediatric patients weighing at least 40 kg.
Lupin is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity.
According to IQVIA MAT data for September 2026, Raltegravir Tablets USP, 600 mg, had estimated annual sales of USD 26 million in the US.
The launch follows a series of recent regulatory approvals secured by Lupin in the US.
A day earlier, the company announced that it had received US FDA approval for its ANDA for Amifampridine Tablets, 10 mg. The product is bioequivalent to Catalyst Pharmaceuticals’ reference listed drug, Firdapse Tablets, 10 mg and is used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disease.
Last month, the company also received US FDA approval for its ANDA for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, in a single-dose prefilled syringe.
The injectable formulation is bioequivalent to International Medication Systems’ reference listed drug and is indicated for the treatment and prophylaxis of hypoprothrombinaemia (low blood clotting) associated with vitamin K deficiency.
Akhil Gupta Joins Lupin Board as Independent Director
Separately, Lupin has appointed Akhil Gupta as an Independent Director to its Board.
Gupta brings more than four decades of experience in business development, corporate strategy, finance, corporate governance and mergers and acquisitions. As Vice Chairman of Bharti Enterprises Limited, he played a key role in the group’s growth through organic expansion and acquisitions.
A qualified Chartered Accountant, Gupta has also completed the Advanced Management Programme at Harvard Business School.
He currently serves as Non-Executive Independent Chairman of 360 ONE WAM, Coforge and Valuedrive Technologies (Spinny). He is also an Independent Director of Lodha Developers and Zepto, and a Nominee Director of Acevector Limited.
In addition, he is President of the Telecom Sector Skill Council, a member of the CII National Committee on Telecom and Broadband and the CII Task Force on Insolvency and Bankruptcy, and Chairman of Inversion Advisory Services. He also advises companies across sectors, including infrastructure, renewable energy, automobiles, tourism, consulate services and footwear.
Commenting on the appointment, Manju D Gupta, Chairperson of Lupin, said, “We are delighted to welcome Akhil to the Lupin Board. He brings a rare combination of strategic perspective, financial acumen, governance experience, and a proven track record of building businesses at scale. His counsel will be valuable as Lupin continues to strengthen its global position and pursue its next phase of growth.”
Lupin Reports Q2 FY2027 Financial Performance
Lupin also reported its financial performance for the quarter ended September 30, 2026.
The company’s gross profit increased 15.4% to INR 57,774 million in the second quarter of FY2027, compared with INR 50,066 million in the corresponding quarter of the previous financial year. The gross margin stood at 74.2%.
