Lupin Limited gains FDA approval for generic equivalent of Esbriet Tablets


Lupin Limited announced today that it has secured approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. These tablets are the generic equivalent of Esbriet Tablets, a product of Hoffmann La Roche Inc. The tablets will be manufactured at Lupin’s state-of-the-art Pithampur facility in India.

Pirfenidone Tablets Set to Capture a Share of USD 218 Million Market

U.S. Market Witnesses Annual Sales of Esbriet Equivalent at USD 218 Million

The approval of the ANDA for Pirfenidone Tablets by the U.S. FDA is a significant development, given the estimated annual sales for the Reference Listed Drug (RLD) Esbriet in the U.S. stands at a lucrative USD 218 million, according to IQVIA MAT as of June 2023. Lupin’s entry into this market segment underscores the company’s growing role in the U.S. pharmaceutical market.

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Manufacturing at Lupin’s Pithampur Facility to Boost Indian Pharma Exports

Lupin’s Pithampur Plant Adds to India’s Pharma Manufacturing Capabilities

The Pirfenidone Tablets will be manufactured at Lupin’s Pithampur facility, further solidifying India’s position as a significant player in the global pharmaceutical landscape. This facility is expected to contribute not just to Lupin’s product portfolio but also to India’s pharma exports, strengthening the country’s standing in the pharmaceutical industry.

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U.S. FDA Approval Adds to Lupin’s Growing Portfolio

Lupin Continues to Expand Its Reach in U.S. Pharmaceutical Market

The U.S. FDA approval for Pirfenidone Tablets serves as another milestone for Lupin Limited in expanding its pharmaceutical offerings in the United States. The generic equivalent of Esbriet Tablets will provide an affordable treatment option for patients, reinforcing Lupin’s commitment to healthcare access and affordability.

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Final Thoughts: Lupin’s Pirfenidone Tablets to Provide Cost-Effective Treatment

Approval Paves the Way for Affordable Medication for U.S. Patients

Lupin’s U.S. FDA-approved Pirfenidone Tablets will soon be available as a cost-effective alternative to Esbriet® Tablets, fulfilling a growing need for affordable healthcare solutions in the United States. This development is in line with Lupin’s broader strategy to diversify and strengthen its pharmaceutical product offerings globally.

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