Strides gets USFDA nod for generic drug with 180-day exclusivity

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Drug firm Strides Pharma Science on Saturday said its subsidiary has received approval from the US 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 US Food and Drug Administration (USFDA).

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 US markets, it added.

Strides said it has 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 will 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 US OTC market for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) is around USD 41 million.

The product will be manufactured at Stride's Bengaluru-based plant and will be marketed by Strides Pharma Inc in the US market. The company said it has now 274 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 251 ANDAs have been approved and 23 are pending approval.

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