FDA Orange Book · active-ingredient family
Lamivudine
Lamivudine: 4 brands, 19 generics; first approved Nov 17, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
19
Listed patents
0
Presentations
35
Brand (NDA) products
Originator applications
- EPIVIR-HBVRLDGLAXOSMITHKLINENDA 0210041998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML SOLUTION ORAL Discontinued — - EPIVIR-HBVRLDGLAXOSMITHKLINENDA 0210031998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - VIIV HLTHCARENDA 0205961995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - EPIVIRRLDVIIV HLTHCARENDA 02056419952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB
Generic (ANDA) products (19)
Abbreviated applications
- LAMIVUDINEHETERO LABS LTD IIIANDA 0914752023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - LAMIVUDINEMACLEODS PHARMSANDA 09019820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINEANNORAANDA 2113062019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - LAMIVUDINEPHARMOBEDIENTANDA 07854520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LAMIVUDINESTRIDES PHARMAANDA 09045720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINECIPLAANDA 07722120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINEAUROBINDO PHARMAANDA 0776952016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - LAMIVUDINEAUROBINDO PHARMAANDA 07746420162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINEBRECKENRIDGEANDA 2035862016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - LAMIVUDINESOMERSET THERAPS LLCANDA 20697420162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINENATCOANDA 20452820162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LAMIVUDINEAUROBINDO PHARMA USAANDA 2040022014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - LAMIVUDINELUPINANDA 20521720142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - LAMIVUDINECHARTWELL MOLECULARANDA 2035642014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - LAMIVUDINEHETERO LABS LTD VANDA 20327720142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINERSAPOTEXANDA 2029412014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - LAMIVUDINEHETERO LABS LTD VANDA 2032602014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - LAMIVUDINEAPOTEXANDA 09160620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - LAMIVUDINEAUROBINDO PHARMA LTDANDA 20203220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued —
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
31 yr 4 mo ago
Most recent approval
3 yr 1 mo ago
Approvals span 1995–2023 across 23 FDA applications.
Brand (NDA) 417%
Generic (ANDA) 1983%
Lamivudine: 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.
Go beyond the database.
Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.