Alembic Pharmaceuticals and Zydus Lifesciences have both received final approvals from the US Food and Drug Administration (USFDA) for generic versions of key medications. Alembic's approval covers Paliperidone Extended-Release Tablets, while Zydus has also received approval for their generic Paliperidone extended-release tablets. Additionally, Alembic secured approval for Diltiazem Hydrochloride Extended-Release Capsules. These approvals mark significant milestones for both companies in expanding their portfolios of generic pharmaceuticals in the US market.
Paliperidone Approval Details
Alembic Pharmaceuticals has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Paliperidone Extended-Release Tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. This product is therapeutically equivalent to Janssen Pharmaceuticals' Invega Extended-Release Tablets. Paliperidone is an atypical antipsychotic used in the treatment of schizophrenia and schizoaffective disorder, either as monotherapy or as an adjunct to mood stabilizers and antidepressants. According to IQVIA data, the market size for Paliperidone Extended-Release Tablets is estimated at $48 million for the twelve months ending June 2024. This approval brings Alembic’s total ANDA approvals to 215, including 187 final approvals and 28 tentative approvals.
Zydus Lifesciences also announced that it has received final approval from the USFDA to manufacture Paliperidone Extended-Release Tablets in the same strengths: 1.5 mg, 3 mg, 6 mg, and 9 mg. These tablets are indicated for the acute and maintenance treatment of schizophrenia, as well as for the acute treatment of schizoaffective disorder, both as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Zydus will produce these tablets at their manufacturing site in Ahmedabad. Paliperidone extended-release tablets had annual sales of US $47.1 million in the United States (IQVIA MAT July 2024).
Diltiazem Hydrochloride Approval Details
Alembic Pharmaceuticals also secured final USFDA approval for its ANDA for Diltiazem Hydrochloride Extended-Release Capsules USP in strengths of 120 mg, 180 mg, and 240 mg. These capsules are therapeutically equivalent to Allergan's Dilacor XR Extended-Release Capsules. Diltiazem hydrochloride is indicated for the treatment of hypertension and chronic stable angina. It can be used alone or in combination with other antihypertensive medications, such as diuretics. IQVIA data indicates an estimated market size of $28.2 million for Diltiazem Hydrochloride Extended-Release Capsules in the US for the twelve months ending June 2024. This approval brings Alembic’s cumulative total of ANDA approvals to 217, with 190 being final approvals.
