FDA Orange Book · active-ingredient family
Lamivudine
Lamivudine is approved as 4 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EPIVIR-HBV · NDA 021004
4
Brand (NDA)
19
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPIVIR-HBVRLD | GLAXOSMITHKLINE | NDA 021004 | — | Dec 08, 1998 | |
| EPIVIR-HBVRLD | GLAXOSMITHKLINE | NDA 021003 | — | Dec 08, 1998 | |
| EPIVIRRLD | VIIV HLTHCARE | NDA 020596 | AA | Nov 17, 1995 | |
| EPIVIRRLD×2 | VIIV HLTHCARE | NDA 020564 | AB | Nov 17, 1995 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LAMIVUDINE | HETERO LABS LTD III | ANDA 091475 | AA | Oct 06, 2023 | |
| LAMIVUDINE×2 | MACLEODS PHARMS LTD | ANDA 090198 | AB | May 01, 2019 | |
| LAMIVUDINE | ANNORA | ANDA 211306 | AB | Mar 21, 2019 | |
| LAMIVUDINE×2 | PHARMOBEDIENT | ANDA 078545 | — | Mar 05, 2019 | |
| LAMIVUDINE×2 | STRIDES PHARMA | ANDA 090457 | AB | Apr 19, 2018 | |
| LAMIVUDINE×2 | CIPLA | ANDA 077221 | AB | Mar 03, 2017 | |
| LAMIVUDINE | AUROBINDO PHARMA | ANDA 077695 | AA | Nov 21, 2016 | |
| LAMIVUDINE×2 | AUROBINDO PHARMA | ANDA 077464 | AB | Nov 21, 2016 | |
| LAMIVUDINE | BRECKENRIDGE | ANDA 203586 | — | Nov 21, 2016 | |
| LAMIVUDINE×2 | SOMERSET THERAPS LLC | ANDA 206974 | AB | Nov 21, 2016 | |
| LAMIVUDINE×2 | NATCO | ANDA 204528 | — | Mar 04, 2016 | |
| LAMIVUDINE | AUROBINDO PHARMA USA | ANDA 204002 | — | Dec 31, 2014 | |
| LAMIVUDINE×2 | LUPIN | ANDA 205217 | — | Dec 18, 2014 | |
| LAMIVUDINE | CHARTWELL MOLECULAR | ANDA 203564 | AA | Oct 31, 2014 | |
| LAMIVUDINE×2 | HETERO LABS LTD V | ANDA 203277 | AB | Jan 06, 2014 | |
| LAMIVUDINE | APOTEX | ANDA 202941 | AB | Jan 02, 2014 | |
| LAMIVUDINE | HETERO LABS LTD V | ANDA 203260 | AB | Jan 02, 2014 | |
| LAMIVUDINE×2 | APOTEX | ANDA 091606 | AB | Dec 02, 2011 | |
| LAMIVUDINE×2 | AUROBINDO PHARMA LTD | ANDA 202032 | — | Nov 17, 2011 |
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.
Lamivudine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
