The U.S. Food and Drug Administration (USFDA) has given Alembic Pharmaceuticals Ltd. final approval to market its generic version of Paliperidone extended-release tablets, the company stated on Friday. These pills are used to treat schizophrenia, a long-term mental illness that impairs a person’s capacity for coherent thought, feeling, and behavior. The strengths that are covered by the approval are 1.5 mg, 3 mg, 6 mg, and 9 mg.
Atypical antipsychotic medication paliperidone is used as a monotherapy or in conjunction with mood stabilizers or antidepressants to treat schizophrenia and schizoaffective disorder. A mental illness known as schizoaffective disease combines the symptoms of mood disorder and schizophrenia. Paliperidone reduces symptoms like hallucinations and enhances mood, thinking, and behavior by aiding in the restoration of certain neurotransmitter balance in the brain.
With Alembic Pharmaceuticals’ approved Abbreviated New Drug Application (ANDA), its Paliperidone tablets are now therapeutically similar to Janssen Pharmaceuticals, Inc.’s Reference Listed Drug (RLD) Invega extended-release tablets. This indicates that Alembic’s generic version is thought to be a more cost-effective option for patients and healthcare systems, with the same efficacy, safety, and quality as the branded version.
Paliperidone extended-release tablets (in the strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg) are expected to have a 48 million USD market size for the 12 months ending in June 2024, according to Alembic Pharmaceuticals, which cited IQVIA statistics. This illustrates the potential market for Alembic’s generic version, enabling the business to capitalize on the rising need for reasonably priced mental health treatment alternatives.
Alembic is pleased with the USFDA’s approval, which broadens the range of goods the company is able to sell in the US market. The business said that it has received 215 ANDA clearances in total from the USFDA, comprising 28 preliminary approvals and 187 final approvals. This illustrates Alembic’s dedication to growing its market share in the US pharmaceutical industry by providing a large selection of generic medications in a variety of therapeutic categories.
In conclusion, Alembic’s Paliperidone extended-release tablet approval by the USFDA is a good step forward that enables the business to provide a more reasonably priced treatment option for schizoaffective disorder and schizophrenia. It also supports the larger initiative to increase access to necessary pharmaceuticals for mental health treatment and fortifies Alembic’s position in the US generic drug market.
SOURCE :
ECONOMIC TIMES
