Granules Pharmaceuticals Inc (GPI), the wholly-owned subsidiary of Granules India, has acquired the exclusive rights from USpharma Windlas, LLC to market and distribute four products in the US.
USpharma Windlas, through its subsidiaries, holds Abbreviated New Drug Applications (ANDAs) for Fingolimod, Prasugrel, Dronedarone and Lurasidone. USpharma Windlas believes to be a first applicant to file ANDAs containing paragraph IV certifications for three of these products.
USpharma Windlas will receive milestone payments and share of the profits from commercial sales.
Granules Pharmaceuticals Inc will be responsible for the marketing and distribution of the products in the US, subject to final approval by the US Food and Drug Administration (USFDA), the company said in a statement.
USpharma Windlas, LLC is a joint venture between USpharma, and Windlas Healthcare. USpharma is a development-stage pharmaceutical company specializing in R&D and manufacturing of high-barrier generic pharmaceuticals, including controlled-release, controlled-substance and patent-challenge products. USpharma has filed these ANDA’s and has a pipeline of several high-barrier products.
According to IMS Health data, the annual US sales for above four products are approximately $4.4 billion.“Product in-licensing is a strategic manoeuvre to accelerate our business expansion plans in the US by fostering long term partnerships” Krishna Prasad Chigurupati, CMD, Granules India said.