Alembic Pharmaceuticals secures USFDA approval for new Paliperidone extended-release tablets

Alembic Pharmaceuticals Limited has achieved a major milestone in the pharmaceutical industry. On September 27, 2024, the company proudly announced that it received final approval from the United States Food and Drug Administration (USFDA) for its Paliperidone Extended-Release Tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. This approval marks a significant development for the treatment of schizophrenia and schizoaffective disorder, providing a new option for patients in need of effective therapeutic solutions.

Paliperidone is a well-established antipsychotic medication, and Alembic’s successful approval positions the company to make a significant impact in the market. According to IQVIA, the market size for Paliperidone Extended-Release Tablets reached $48 million in the twelve months ending in June 2024. This approval signals Alembic’s readiness to penetrate the U.S. market with a competitive, cost-effective alternative to the branded drug Invega, which is produced by Janssen Pharmaceuticals Inc.

The Paliperidone Extended-Release Tablets, approved by the USFDA, are therapeutically equivalent to Janssen Pharmaceuticals’ Invega Extended-Release Tablets. These tablets are vital for treating schizophrenia, a chronic and severe mental disorder, and schizoaffective disorder, either as a stand-alone treatment or in combination with other mood stabilizers and antidepressants. Paliperidone has been proven to improve symptoms in patients suffering from these debilitating conditions, offering them the possibility of a more stable and manageable life.

Alembic Pharmaceuticals now has a cumulative total of 215 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which includes 187 final approvals. This latest approval demonstrates the company’s continued excellence in the field of generic pharmaceuticals. Alembic Pharmaceuticals has been a leader in branded generics for over a century, since its founding in 1907. The company’s modern research and manufacturing facilities have garnered approvals from regulatory bodies around the globe, cementing its status as a trusted provider of high-quality medicines.

According to an industry expert, Alembic’s recent approval is not only a significant milestone for the company but also for the broader pharmaceutical industry. This approval provides more affordable medication options for patients suffering from schizophrenia and schizoaffective disorder, conditions that require long-term treatment. Alembic’s expanded presence in the U.S. market will also foster more competition, which could ultimately benefit healthcare systems and patients alike. The expert emphasized that Alembic’s leadership in branded generics is unmatched, and its vast experience in global markets puts it in an excellent position to leverage this new opportunity.

Alembic’s management expressed their excitement over this approval, stating that it reflects their ongoing dedication to improving global healthcare by providing access to safe, effective, and affordable medications. The company continues to focus on bringing new and essential treatments to market, particularly in the areas of mental health and chronic disease management.

Paliperidone Extended-Release Tablets represent a significant opportunity for Alembic Pharmaceuticals as it deepens its presence in the U.S. pharmaceutical market. With the drug’s ability to manage symptoms in patients suffering from schizophrenia and schizoaffective disorder, Alembic is well-positioned to deliver a high-impact solution for this challenging mental health condition.

Experts in the pharmaceutical industry are highlighting the importance of this approval for the market. Paliperidone Extended-Release Tablets are expected to create new opportunities for healthcare providers by offering a lower-cost alternative to established brands. This competition could drive down prices, benefiting both healthcare systems and patients. Experts predict that Alembic Pharmaceuticals’ new approval will bolster its growth and enhance its reputation as a key player in both branded generics and the broader global pharmaceutical industry.