Strides Pharma receives USFDA nod for Ibuprofen OTC Oral Suspension; Stock tumbles 4%

13 Jun 2022 , 11:20 AM

Strides Pharma Science Limited (Strides) has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Infants’ Advil Concentrated Drops, 50 mg/1.25 mL (40 mg/mL) (OTC), of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The Product approval further strengthens Strides Ibuprofen franchise for the US markets.

Strides was 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). Strides will have a 180 days of Competitive Generic Therapy (CGT) exclusivity for the product, under section 505(j)(5)(B)(v) of the FD&C Act.

The US OTC market for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) is approximately ~US$ 41 Mn. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market, said company in a filing.

The company has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 251 ANDAs have been approved and 23 are pending approval. The company currently has ~60 commercialized products in the US and has set a target to launch ~ 20 new products every year from the combined portfolio.

At around 11;23 AM, Strides Pharma Science was trading at Rs301.80 apiece down by Rs12.4 or 3.95% on the BSE.