February 2025
Published: 24 Dec 2024
Author: Precedence Research
The drug company Alembic Pharmaceuticals finally got approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approval was a milestone for Alembic, as it provided high-quality, low-cost generic alternatives to AbbVie Inc. Depakote Sprinkle Capsules, 125 mg. This drug is commonly used as an anti-epileptic in a range of seizure disorders, including complex partial, simple, and complex absence seizures, as well as mixed seizure types. The market for this drug has been approximately $61.1 million for about 12 months ending in September 2024; moreover, it offers Alembic a chance to strengthen its position within the US health market. This is the 193rd final ANDA approval for Alembic, further demonstrating its prowess in pharmaceutical development and regulatory compliance.
Divalproex Sodium is the best approved anti-epileptic drug for several seizure types, including as monotherapy or adjunctive therapy for complex partial seizures. Divalproex also includes treatment indications for simple and complex absence seizures. Because of the high prevalence of multiple types of seizures, it can be used as an adjunct to therapy. It is a cost-effective alternative to the reference-listed medicine, Depakote Sprinkle Capsules, 125 mg, from AbbVie Inc. The 12-month market size of this drug, Divalproex Sodium Delayed-Release Capsules USP 125 mg, is roughly worth $61.1 million, ending September 2024. Zunairah Pharmaceuticals, the company behind the drug, enjoys an impressive 220 ANDAs from the USFDA, including 193 final approvals and 27 tentative approvals. It is also assigned therapeutically equivalent to the established generic, thus satisfying all standards of efficacy and safety compared to the innovator product. The formulation with the delayed release minimizes frequency and improves patient compliance in taking the medication.
Final Approval by the US FDA on Alembic Pharmaceuticals showcases their mark of excellence in safety and quality standards in pharmaceutical manufacturing. This milestone forces Alembic to root further in the U.S. market, which is one of the most competitive and regulated markets globally. Alembic Pharmaceuticals holds a strong product pipeline focused on the increase in ANDA filings. Recent achievements involve primary regulatory approvals in key therapeutic areas, investment in high-tech manufacturing facilities, and strong business alliances. The launch of Alembic's Divalproex Sodium Delayed-Release Capsules will offer seizure patients a much more cost-effective treatment option and a viable alternative for healthcare providers to branded medications.
The United States Food and Drug Administration (USFDA) has approved Alembic Pharmaceuticals for its Divalproex Sodium Delayed-Release Capsules USP, 125 mg. This marks a significant stepping stone for the company and the industry since it will further reaffirm quality, innovation, and affordability for the customers.
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