Strides gets U.S. FDA nod for generic drug with 180-day exclusivity

Drug firm Strides Pharma Science on Saturday said its subsidiary had received approval from the U.S. health regulator to market Ibuprofen Oral Suspension, used for the treatment of pain and fever, in the American market.

Singapore-based Strides Pharma Global Pte, a step-down wholly owned subsidiary of the company, has received approval for its product from the U.S. Food and Drug Administration (FDA).

The company’s product is therapeutically equivalent to GlaxoSmithKline Consumer Healthcare Holdings’ Advil Concentrated Drops, Strides Pharma Science said in a statement.

The product approval further strengthens the company’s Ibuprofen franchise for the U.S. markets, it added.

Strides said it had been granted a Competitive Generic Therapy (CGT) designation for its ANDA and is the “first approved applicant” for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).

The drug firm would have 180 days of Competitive Generic Therapy (CGT) exclusivity for the product, it added.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions, such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.

The U.S. OTC market for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) is about $41 million.

The product will be manufactured at Stride’s Bengaluru-based plant and marketed by Strides Pharma Inc in the U.S. market.

The company said it now has 274 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with U.S. FDA, of which 251 ANDAs have been approved and 23 are pending approval.

The drug firm currently has 60 commercialised products in the U.S. and has set a target to launch 20 new products every year from the combined portfolio.