FDA Orange Book · active-ingredient family
Abacavir sulfate; lamivudine
Abacavir sulfate; lamivudine is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ABACAVIR SULFATE AND LAMIVUDINE · NDA 204311
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINERLD | PHARMOBEDIENT | NDA 204311 | — | Dec 22, 2023 | |
| EPZICOMRLD | VIIV HLTHCARE | NDA 021652 | — | Aug 02, 2004 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | HETERO LABS LTD V | ANDA 205412 | AB | Apr 16, 2025 | |
| ABACAVIR SULFATE AND LAMIVUDINE | MACLEODS PHARMS LTD | ANDA 212663 | — | Dec 19, 2024 | |
| ABACAVIR SULFATE AND LAMIVUDINE | LAURUS | ANDA 216332 | AB | Jul 25, 2022 | |
| ABACAVIR SULFATE AND LAMIVUDINE | AUROBINDO PHARMA LTD | ANDA 090159 | AB | Nov 15, 2018 | |
| ABACAVIR SULFATE AND LAMIVUDINE | ZYDUS PHARMS | ANDA 208990 | — | Nov 15, 2018 | |
| ABACAVIR SULFATE AND LAMIVUDINE | AUROBINDO PHARMA | ANDA 206151 | — | Mar 28, 2017 | |
| ABACAVIR SULFATE AND LAMIVUDINE | CHARTWELL RX | ANDA 204990 | AB | Mar 28, 2017 | |
| ABACAVIR SULFATE AND LAMIVUDINE | CIPLA | ANDA 091144 | AB | Mar 28, 2017 | |
| ABACAVIR SULFATE AND LAMIVUDINE | TEVA PHARMS USA | ANDA 079246 | — | Sep 29, 2016 |
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.
Abacavir sulfate; lamivudine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
