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FDA Orange Book · active-ingredient family

Lamivudine; tenofovir disoproxil fumarate

Lamivudine; tenofovir disoproxil fumarate: 3 brands, 0 generics; first approved Feb 28, 2018.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity — brand product(s) only.

Brands (NDA)
3
Generics (ANDA)
0
Listed patents
0
Presentations
3
Originator applications

Brand (NDA) products

TEMIXYSRLD
NDA 2112842018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
300MG;300MGTABLETORALDiscontinued—
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATERLD
NDA 0223442018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
300MG;300MGTABLETORALDiscontinued—
CIMDUORLDRS
NDA 0221412018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
300MG;300MGTABLETORALRx—
Orange Book patent file

Listed patents

Listed patents

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.

FDA approval span

Approval history

First approval
Feb 28, 2018
8 yr 6 mo ago
Most recent approval
Nov 16, 2018
7 yr 9 mo ago

All 3 applications were approved in 2018.

Brand (NDA) 3100%
Generic (ANDA) 00%

Lamivudine; tenofovir disoproxil fumarate — 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.

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