Alembic Pharma Receives USFDA Approval for Generic Hypertension Drug
Key Insights
Alembic Pharmaceuticals has secured USFDA approval for Diltiazem Hydrochloride Extended-Release capsules (search), a generic alternative to Cardizem CD (search).
The approved capsules, available in multiple dosages, are indicated for treating hypertension (search) and angina (search).
The market for Diltiazem Hydrochloride Extended-Release Capsules (search) is estimated at $105.3 million in the U.S.
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Extended-Release capsules (search). These capsules, available in 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg dosages, are a generic version of Bausch Health’s Cardizem CD (search) and are indicated for the treatment of hypertension (search). The approval marks a significant step for Alembic Pharma (search) in expanding its presence in the U.S. generics market.
Therapeutic Applications
Diltiazem Hydrochloride Extended-Release Capsules (search) are prescribed for managing hypertension (search), either as a standalone treatment or in combination with other antihypertensive medications. Additionally, they are used to treat chronic stable angina (search) and angina caused by coronary artery spasm. These conditions represent a substantial patient population, making this generic approval clinically relevant.
Market Opportunity
According to IQVIA data, the U.S. market for Diltiazem Hydrochloride Extended-Release Capsules (search) is valued at approximately $105.3 million for the 12-month period ending in June 2024. Alembic Pharma (search)'s entry into this market provides a cost-effective alternative for patients requiring this medication.
Alembic's Expanding Portfolio
With this latest approval, Alembic Pharmaceuticals now holds 218 Abbreviated New Drug Application (ANDA) approvals from the USFDA, including 191 final approvals and 27 tentative approvals. This achievement underscores the company's robust research and development capabilities and its commitment to delivering affordable healthcare solutions.
Alembic Pharmaceuticals, established in 1907, has a strong focus on research and development. The company operates advanced manufacturing facilities that are approved by regulatory authorities across multiple countries, including the USFDA. In addition to its generics business in the U.S., Alembic is a leading player in the branded generics market in India.