Lyka Labs Limited has announced that it has been granted an Indian Patent for its proprietary product, Pregabalin Gel 8%, with patent protection valid through 2043. This significant milestone reinforces Lyka’s focus on innovation and its leadership in developing topical drug delivery systems.

Pregabalin Gel 8%, a topical formulation designed for the effective management of diabetic neuropathic pain, received regulatory approval from the Central Drugs Standard Control Organization (CDSCO) in October 2024 for manufacturing and marketing in India. The product was officially launched in December 2024 by Torrent Pharmaceuticals, Intas Pharmaceuticals, and Zuventus Healthcare under a P2P (Product-to-Product) license from Lyka Labs.

This gel formulation represents a first-of-its-kind innovation in India, offering localized delivery of pregabalin directly at the site of pain, potentially minimizing systemic exposure and related side effects commonly associated with oral formulations.

Lyka Labs has conducted clinical studies supporting the efficacy, safety, and patient convenience of Pregabalin Gel 8%, making it a promising alternative for millions suffering from chronic diabetic neuropathic conditions.