FDA Orange Book

Generic for Tamiflu

Tamiflu contains oseltamivir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Tamiflu is oseltamivir. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Tamiflu products the Orange Book lists.

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Tamiflu products in the Orange Book

Tamiflu products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 30MG BASEDiscontinuedNone16AB
capsule, oralEQ 45MG BASEDiscontinuedNone15AB
capsule, oralEQ 75MG BASEMarketed (Rx)AB16AB
for suspension, oralEQ 12MG BASE/MLDiscontinuedNone0None
for suspension, oralEQ 6MG BASE/MLMarketed (Rx)AB15AB

NDA 021087, 021246, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic oseltamivir

Approved generic versions of Tamiflu
CompanyANDATE codeApprovedStrengths
NATCO PHARMA LTD202595AB (A-rated, therapeutically equivalent)August 3, 2016EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
ZYDUS PHARMACEUTICALS USA INC208578AB (A-rated, therapeutically equivalent)February 24, 2017EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC209093AB (A-rated, therapeutically equivalent)May 17, 2017EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
MACLEODS PHARMACEUTICALS LTD207211AB (A-rated, therapeutically equivalent)September 14, 2017EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
ZYDUS PHARMACEUTICALS USA INC209113AB (A-rated, therapeutically equivalent)September 14, 2017EQ 6MG BASE/ML
ALVOGEN INC208823AB (A-rated, therapeutically equivalent)October 31, 2017EQ 6MG BASE/ML
LUPIN INC208348AB (A-rated, therapeutically equivalent)January 9, 2018EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
LUPIN INC208347AB (A-rated, therapeutically equivalent)February 20, 2018EQ 6MG BASE/ML
HETERO LABS LTD UNIT III209438AB (A-rated, therapeutically equivalent)February 23, 2018EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
STRIDES PHARMA GLOBAL PTE LTD209421AB (A-rated, therapeutically equivalent)June 8, 2018EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
TEVA PHARMACEUTICALS USA INC211125AB (A-rated, therapeutically equivalent)February 27, 2019EQ 6MG BASE/ML
ALEMBIC PHARMACEUTICALS LTD211823AB (A-rated, therapeutically equivalent)June 24, 2019EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
SUNSHINE LAKE PHARMA CO LTD212739AB (A-rated, therapeutically equivalent)March 4, 2020EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
MSN LABORATORIES PRIVATE LTD212544AB (A-rated, therapeutically equivalent)May 20, 2020EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
AJANTA PHARMA LTD212784AB (A-rated, therapeutically equivalent)May 27, 2020EQ 6MG BASE/ML
INVAGEN PHARMACEUTICALS INC212858AB (A-rated, therapeutically equivalent)August 30, 2021EQ 6MG BASE/ML
EPIC PHARMA LLC215208AB (A-rated, therapeutically equivalent)October 1, 2021EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
SUNSHINE LAKE PHARMA CO LTD213594AB (A-rated, therapeutically equivalent)January 5, 2022EQ 6MG BASE/ML
STRIDES PHARMA GLOBAL PTE LTD211894AB (A-rated, therapeutically equivalent)January 13, 2022EQ 6MG BASE/ML
HETERO LABS LTD UNIT V209590AB (A-rated, therapeutically equivalent)March 28, 2022EQ 6MG BASE/ML
MSN LABORATORIES PRIVATE LTD215313AB (A-rated, therapeutically equivalent)May 2, 2022EQ 6MG BASE/ML
EPIC PHARMA LLC215538AB (A-rated, therapeutically equivalent)February 14, 2023EQ 6MG BASE/ML
INVAGEN PHARMACEUTICALS INC217467AB (A-rated, therapeutically equivalent)October 3, 2023EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
LAURUS LABS LTD218565AB (A-rated, therapeutically equivalent)May 1, 2024EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
AUROBINDO PHARMA LTD218131AB (A-rated, therapeutically equivalent)May 10, 2024EQ 6MG BASE/ML
PHARMOBEDIENT CONSULTING LLC217303AB (A-rated, therapeutically equivalent)July 2, 2024EQ 6MG BASE/ML
BEIJING JIALIN PHARMACEUTICAL CO LTD217133AB (A-rated, therapeutically equivalent)October 30, 2024EQ 30MG BASE, EQ 75MG BASE
JUBILANT GENERICS LTD213695AB (A-rated, therapeutically equivalent)March 3, 2025EQ 6MG BASE/ML
SHANDONG NEW TIME PHARMACEUTICAL CO LTD217274AB (A-rated, therapeutically equivalent)July 9, 2025EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
ZHEJIANG POLY PHARM CO LTD218009AB (A-rated, therapeutically equivalent)October 2, 2025EQ 30MG BASE, EQ 45MG BASE, EQ 75MG BASE
ALEMBIC PHARMACEUTICALS LTD218307AB (A-rated, therapeutically equivalent)June 25, 2026EQ 6MG BASE/ML

Tamiflu NDC codes

Questions

Is there a generic for Tamiflu?

Yes. The generic name for Tamiflu is oseltamivir. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Tamiflu products the Orange Book lists.

What is the generic name for Tamiflu?

The active ingredient in Tamiflu is oseltamivir, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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