Alembic Pharma Secures USFDA Approval for Generic Tamiflu Oral Suspension, Expands US Portfolio

Alembic Pharma Receives USFDA Approval for Generic Tamiflu Oral Suspension

Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, marking another milestone in the company's expanding U.S. generics portfolio. The approval allows Alembic to market a generic version of Tamiflu Oral Suspension, 6 mg/mL, a widely prescribed antiviral medication for influenza treatment and prevention.

Generic Equivalent to Roche's Tamiflu

The approved product is therapeutically equivalent to the reference listed drug (RLD), Hoffmann-La Roche Inc.'s Tamiflu Oral Suspension, 6 mg/mL. Oseltamivir Phosphate belongs to the neuraminidase inhibitor (NAI) class of antiviral medicines used to combat influenza infections.

Approved Uses

According to the approved labeling, Oseltamivir Phosphate for Oral Suspension, 6 mg/mL is indicated for:

• Treatment of acute, uncomplicated influenza A and influenza B in patients aged two weeks and older who have experienced symptoms for no more than 48 hours.
• Prophylaxis (prevention) of influenza A and influenza B in patients aged one year and older.

The company advised healthcare professionals to refer to the complete prescribing information for detailed indications, dosage recommendations, and safety guidance.

Estimated U.S. Market Opportunity

According to IQVIA data cited by the company, Oseltamivir Phosphate for Oral Suspension, 6 mg/mL recorded an estimated U.S. market size of approximately US$27 million for the 12-month period ending March 2026, presenting an additional commercial opportunity for Alembic in the U.S. anti-infective segment.

Alembic Strengthens USFDA Approval Portfolio

With this latest approval, Alembic Pharmaceuticals has now received a cumulative total of 243 ANDA approvals from the USFDA, comprising 223 final approvals and 20 tentative approvals. The latest approval further strengthens the company's presence in the highly competitive U.S. generic pharmaceutical market while expanding its portfolio of anti-infective products.

About Alembic Pharmaceuticals

Alembic Pharmaceuticals Limited, established in 1907, is an India-based, vertically integrated pharmaceutical company engaged in the research, development, manufacturing, and marketing of generic medicines worldwide. The company's manufacturing and research facilities are approved by multiple international regulatory authorities, including the USFDA, and it remains one of India's leading branded generics manufacturers.