Alembic Pharmaceuticals Limited, a prominent player in the global pharmaceutical industry, announced on December 20, 2024, that it has received final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Capsules USP, 125 mg. This approval paves the way for the company to manufacture and market a generic version of Depakote Sprinkle Capsules, 125 mg, produced by AbbVie Inc.
Key Highlights of the Approval:
- Therapeutic Use: The drug is indicated for monotherapy and adjunctive therapy for managing complex partial seizures, simple and complex absence seizures, and multiple seizure types that include absence seizures. It plays a critical role in epilepsy treatment.
- Market Opportunity: Divalproex Sodium Delayed-Release Capsules USP, 125 mg, has an estimated market size of $61.1 million for the twelve months ending September 2024, according to IQVIA.
- Global Milestone: This approval enhances Alembic’s portfolio of USFDA-approved drugs, which now totals 220 ANDA approvals, including 193 final approvals and 27 tentative approvals.
About Alembic Pharmaceuticals: Established in 1907, Alembic Pharmaceuticals Limited has been a pioneer in the healthcare industry. The company is headquartered in India and has a robust global presence. Known for its advanced research and manufacturing capabilities, Alembic is a leading producer of branded and generic pharmaceuticals. Its facilities are approved by regulatory authorities from developed countries, including the USFDA.
