Alembic Pharmaceuticals Gains USFDA Approval for Sumatriptan Injection
Filing Summary
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. This product is therapeutically equivalent to GlaxoSmithKline’s Imitrex STATdose System. The market size for this product is estimated at USD 73 million for the twelve months ending September 2025. Alembic now holds a cumulative total of 228 ANDA approvals from the USFDA, including 207 final approvals and 21 tentative approvals.
Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approval confirms therapeutic equivalence to the reference listed drug, Imitrex STATdose System, by GlaxoSmithKline Intellectual Property Ltd.
The Sumatriptan Injection is indicated for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache in adults. This approval marks Alembic’s first drug device combination product. According to IQVIA, the estimated market size for this product is USD 73 million for the twelve months ending September 2025.
Alembic Pharmaceuticals has achieved a cumulative total of 228 ANDA approvals from the USFDA, comprising 207 final approvals and 21 tentative approvals. This milestone reflects the company’s ongoing commitment to expanding its portfolio of generic pharmaceutical products in the global market.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It focuses on manufacturing and marketing generic pharmaceutical products worldwide. The company is recognized for its state-of-the-art research and manufacturing facilities, which are approved by regulatory authorities in several developed countries, including the USFDA. Alembic is a leader in branded generics in India, with a significant presence in the healthcare sector since 1907.