Alembic Pharma Gains USFDA Approval for Generic Hypertension Drug Diltiazem Hydrochloride

Key Insights

• Alembic Pharmaceuticals received USFDA approval for Diltiazem Hydrochloride Extended-Release capsules, a generic alternative to Bausch Health's Cardizem CD, used to treat hypertension.
• The approved capsules are available in multiple dosages (120 mg to 360 mg) and can be used alone or with other antihypertensive medications for managing hypertension and angina.
• The market for Diltiazem Hydrochloride Extended-Release capsules is valued at approximately $105.3 million in the US, based on recent IQVIA data for the twelve months ending June 2024.

Alembic Pharmaceuticals announced it has secured approval from the U.S. Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Extended-Release capsules. The approval, announced on November 11, 2024, allows Alembic to market a generic version of Bausch Health’s Cardizem CD, a medication used in the treatment of hypertension.

The Diltiazem Hydrochloride Extended-Release capsules are available in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. These capsules are indicated for the management of hypertension, offering patients and healthcare providers a cost-effective alternative to the branded product. The drug can be used as a standalone treatment or in conjunction with other antihypertensive medications to achieve optimal blood pressure control.

Clinical Applications and Market Size

Beyond hypertension, Diltiazem Hydrochloride Extended-Release capsules are also prescribed for the management of chronic stable angina and angina resulting from coronary artery spasms. This dual indication broadens the potential impact of Alembic's generic offering.

According to IQVIA data, the U.S. market for Diltiazem Hydrochloride Extended-Release capsules in the specified dosages is valued at approximately $105.3 million for the twelve-month period ending in June 2024. This represents the potential market size Alembic can now address with its approved generic product.

Alembic's Expanding Portfolio

This latest approval marks a significant milestone for Alembic Pharmaceuticals, bringing its total number of ANDA (Abbreviated New Drug Application) approvals from the USFDA to 218. This total includes 191 final approvals and 27 tentative approvals, underscoring the company's growing presence and capabilities in the U.S. generics market.

Manufacturing Compliance

In related news, Alembic Pharma reported the successful completion of a USFDA inspection at its oncology formulation facility in Panelav, Gujarat, in October. The inspection, which concluded on October 8, resulted in no observations, highlighting the facility's adherence to stringent manufacturing standards and regulatory requirements.