Alembic Pharmaceuticals secures final approval from FDA for hypertension drug

Alembic Pharmaceuticals Limited has successfully secured final approval from the US Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Extended-Release Capsules USP, in strengths of 120 mg, 180 mg, and 240 mg. This approval is for the company’s Abbreviated New Drug Application (ANDA) and is therapeutically equivalent to Dilacor XR, a product of Allergan Sales LLC.

Alembic Pharmaceuticals revealed that the newly approved drug targets the hypertension market and can be used both independently and in conjunction with other antihypertensive agents, such as diuretics. Additionally, the medication is suitable for managing chronic stable angina. The market for Diltiazem Hydrochloride Extended-Release Capsules is estimated at $28.2 million, as per IQVIA data for the twelve months ending in June 2024.

Market Impact and Product Reach

Alembic Pharmaceuticals, a company with a rich history dating back to 1907, emphasized that this approval strengthens its presence in the hypertension treatment market in the United States. The company’s cumulative total of ANDA approvals has now reached 217, including 190 final approvals and 27 tentative approvals.

The Diltiazem Hydrochloride Extended-Release Capsules, designed to manage hypertension and chronic stable angina, offer a generic alternative to Allergan’s brand, enabling the company to target an expanding market segment. Alembic’s existing footprint and expertise in the pharmaceutical industry are expected to enhance the availability and affordability of this essential medication.

Expert Opinion

Pharmaceutical analysts suggest that the approval could serve as a catalyst for Alembic’s market growth. Industry experts noted that Alembic’s extensive experience in developing and marketing generic drugs positions it advantageously in a highly competitive space. One expert highlighted that the market size of $28.2 million presents a significant opportunity for Alembic to scale and capture market share, especially as healthcare providers increasingly opt for cost-effective treatment options.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals is a publicly listed company, boasting state-of-the-art research and manufacturing facilities approved by multiple global regulatory authorities, including the USFDA. Known for its strong portfolio of branded generics, Alembic markets its products worldwide through a robust marketing team of over 5,000 professionals. The company remains committed to developing innovative and affordable solutions for healthcare.