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Lupin cleared to market generic Tamiflu suspension

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BALTIMORE — Lupin Pharmaceuticals Inc., the U.S. arm of India-based Lupin Ltd., has received Food and Drug Administration approval for oseltamivir phosphate oral suspension 6 mg (base)/ml, a flu medication.

Lupin said its oseltamivir oral suspension product, set to roll out soon, is a generic version of Tamiflu oral suspension (6 mg/ml) from Hoffman-La Roche Inc.

Oseltamivir phosphate oral suspension is indicated for the treatment of acute, uncomplicated influenza A and B in patients ages 2 weeks and older who have had flu symptoms for no more than 48 hours, as well as for the prophylaxis of influenza A and B in patients ages 1 year and older.

U.S. sales of generic and branded oseltamivir phosphate oral suspension (6 mg/ml) totaled about $358 million for the 12 months through October 2017, according to IQVIA market data reported by Lupin.

Earlier in the month, as flu became more widespread in the United States, Lupin was approved by the FDA to release oseltamivir phosphate capsules in strengths of 30 mg, 45 mg and 75 mg, a generic version of Tamiflu capsules from Hoffman-La Roche.

Oseltamivir phosphate capsules in 30 mg, 45 mg and 75 mg dosages had U.S. sales of $467.8 million for the 12 months ended in October 2017, based on IQVIA data.


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