FDA Orange Book · active-ingredient family
Oseltamivir phosphate
Oseltamivir phosphate: 2 brands, 37 generics; first approved Oct 27, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 37 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
37
Listed patents
0
Presentations
81
Brand (NDA) products
Originator applications
- ROCHENDA 02124620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12MG BASE/ML FOR SUSPENSION ORAL Discontinued — EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - TAMIFLURLDROCHENDA 02108720073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Discontinued — EQ 30MG BASE CAPSULE ORAL Discontinued —
Generic (ANDA) products (37)
Abbreviated applications
- OSELTAMIVIR PHOSPHATEALEMBICANDA 2183072026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEUPSHER SMITH LABSANDA 21343720263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Discontinued — EQ 45MG BASE CAPSULE ORAL Discontinued — EQ 75MG BASE CAPSULE ORAL Discontinued — - OSELTAMIVIR PHOSPHATEZHEJIANG POLY PHARMANDA 21800920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE CAPSULE ORAL Rx AB EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATESHANDONGANDA 21727420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEJUBILANT GENERICSANDA 2136952025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATECEDIPROF INCANDA 21745120243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Discontinued — EQ 45MG BASE CAPSULE ORAL Discontinued — EQ 75MG BASE CAPSULE ORAL Discontinued — - OSELTAMIVIR PHOSPHATEBEIJING JIALINANDA 21713320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEPHARMOBEDIENTANDA 2173032024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEAUROBINDO PHARMA LTDANDA 2181312024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATELAURUSANDA 21856520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEINVAGEN PHARMSANDA 21746720233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEEPIC PHARMA LLCANDA 2155382023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEACCORD HLTHCAREANDA 21472620223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Discontinued — EQ 45MG BASE CAPSULE ORAL Discontinued — EQ 75MG BASE CAPSULE ORAL Discontinued — - OSELTAMIVIR PHOSPHATEMSNANDA 2153132022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEHETERO LABS LTD VANDA 2095902022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATELEADINGANDA 2149492022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Discontinued — - OSELTAMIVIR PHOSPHATESTRIDES PHARMAANDA 2118942022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATESUNSHINEANDA 2135942022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEEPIC PHARMA LLCANDA 21520820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEINVAGEN PHARMSANDA 2128582021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATERISINGANDA 21015720213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Discontinued — EQ 45MG BASE CAPSULE ORAL Discontinued — EQ 75MG BASE CAPSULE ORAL Discontinued — - OSELTAMIVIR PHOSPHATEAJANTA PHARMA LTDANDA 2127842020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEMSNANDA 21254420203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATESUNSHINEANDA 21273920203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEALEMBICANDA 21182320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATETEVA PHARMS USAANDA 2111252019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATESTRIDES PHARMAANDA 20942120183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEAMNEAL PHARMS NYANDA 2101862018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Discontinued — - OSELTAMIVIR PHOSPHATEHETERO LABS LTD IIIANDA 20943820183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATELUPINANDA 2083472018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATELUPINANDA 20834820183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEALVOGENANDA 2088232017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEMACLEODS PHARMS LTDANDA 20721120173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEZYDUS PHARMSANDA 2091132017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/ML FOR SUSPENSION ORAL Rx AB - OSELTAMIVIR PHOSPHATEAMNEAL PHARMSANDA 20909320173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATEZYDUS PHARMSANDA 20857820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - OSELTAMIVIR PHOSPHATENATCOANDA 20259520163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB EQ 45MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
27 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1999–2026 across 39 FDA applications.
Brand (NDA) 25%
Generic (ANDA) 3795%
Oseltamivir phosphate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
