On January 30, 2026, Indoco Remedies Ltd., a Mumbai-based integrated pharmaceutical company, received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Lacosamide Oral Solution USP, 10 mg/mL. This generic formulation is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vimpat Oral Solution 10 mg/mL, originally developed and marketed by UCB, Inc.
Lacosamide is an antiepileptic medication used as adjunctive therapy to treat partial-onset (focal) seizures and primary generalized tonic-clonic seizures in patients with epilepsy. It is approved for use in adults and pediatric patients aged 4 years and older. The oral solution form provides a convenient administration option, particularly for patients who have difficulty swallowing tablets or require precise dosing adjustments.
The approval enables Indoco to market and distribute the product in the United States. Manufacturing will occur at the company’s USFDA-approved facility located at L-14, Verna Industrial Area, Verna, Goa – 403722, India. No information on patent challenges, exclusivity periods (e.g., 180-day generic exclusivity), or launch timelines was specified in the release.
Commenting on the milestone, Ms. Aditi Panandikar, Managing Director of Indoco Remedies, stated: “We are excited about the ANDA approval for Lacosamide Oral Solution USP, 10 mg/ml. This approval further reinforces our commitment to delivering high-quality healthcare to patients worldwide.” The approval expands Indoco’s growing portfolio of complex generics in the US market, where the company focuses on high-barrier products. Indoco, with annual turnover around US$180 million and over 6,000 employees, operates 11 manufacturing facilities (including 7 for finished dosage forms) and maintains approvals from major regulators such as USFDA and UK-MHRA. The company supplies generics globally through partnerships with large international players.
This development supports greater access to affordable antiepileptic therapy in the US, where epilepsy affects millions and generic options help reduce treatment costs. It aligns with Indoco’s strategy to strengthen its presence in regulated markets through quality-driven generics, contributing to broader patient access to essential medicines. No specific market size, sales projections, or competitive details were disclosed.
Link: https://www.indoco.com/media-press-releases/press-release-30Jan26.pdf
