FDA Orange Book · active-ingredient family
Acyclovir
Acyclovir is approved as 7 brand and 70 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AVACLYR · NDA 202408
7
Brand (NDA)
70
Generics (ANDA)
3
Listed patents
1
Exclusivity periods
Brand (NDA) products · capsule, cream, ointment, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AVACLYRRLD | FERA PHARMS LLC | NDA 202408 | — | Mar 29, 2019 | |
| SITAVIGRLD | LIGAND PHARMS | NDA 203791 | — | Apr 12, 2013 | |
| ZOVIRAXRLD | BAUSCH | NDA 021478 | AB | Dec 30, 2002 | |
| ZOVIRAXRLD×2 | PHARMOBEDIENT | NDA 020089 | — | Apr 30, 1991 | |
| ZOVIRAXRLD | PHARMOBEDIENT | NDA 019909 | — | Dec 22, 1989 | |
| ZOVIRAXRLD | PHARMOBEDIENT | NDA 018828 | — | Jan 25, 1985 | |
| ZOVIRAXRLD | BAUSCH | NDA 018604 | AB | Mar 29, 1982 |
Generic (ANDA) products (70)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACYCLOVIR | CIPLA | ANDA 212981 | — | May 02, 2025 | |
| ACYCLOVIR | SUN PHARMA CANADA | ANDA 205470 | AB | Jun 12, 2024 | |
| ACYCLOVIR | ALEMBIC | ANDA 212361 | AB | Nov 21, 2023 | |
| ACYCLOVIR | MSN | ANDA 217393 | AB | Mar 09, 2023 | |
| ACYCLOVIR | ZYDUS LIFESCIENCES | ANDA 206770 | BX | Feb 28, 2023 | |
| ACYCLOVIR | RUBICON RESEARCH | ANDA 215724 | AB | Aug 18, 2022 | |
| ACYCLOVIR | HETERO LABS LTD III | ANDA 215669 | AB | Jul 01, 2022 | |
| ACYCLOVIR | AUROBINDO PHARMA | ANDA 216331 | AB | Mar 31, 2022 | |
| ACYCLOVIR | PRINSTON INC | ANDA 212202 | — | Nov 15, 2021 | |
| ACYCLOVIR | MACLEODS PHARMS LTD | ANDA 212444 | AB | May 19, 2021 | |
| ACYCLOVIR | VISTAPHARM LLC | ANDA 213951 | — | Jan 11, 2021 | |
| ACYCLOVIR | AMNEAL | ANDA 208766 | AB | Nov 09, 2020 | |
| ACYCLOVIR | YILING | ANDA 212173 | AB | Sep 14, 2020 | |
| ACYCLOVIR | NOVITIUM PHARMA | ANDA 212252 | AB | Jul 10, 2020 | |
| ACYCLOVIR | CHARTWELL RX | ANDA 212718 | AB | Apr 23, 2020 | |
| ACYCLOVIR | CHARTWELL RX | ANDA 212495 | AB | Apr 07, 2020 | |
| ACYCLOVIR | XIROMED | ANDA 201501 | AB | Jan 29, 2020 | |
| ACYCLOVIR×2 | SQUARE PHARMS | ANDA 209366 | AB | Oct 07, 2019 | |
| ACYCLOVIR | APOTEX | ANDA 210774 | — | Sep 06, 2019 | |
| ACYCLOVIR | ZYDUS LIFESCIENCES | ANDA 205974 | AB | Mar 15, 2019 | |
| ACYCLOVIR | PADAGIS ISRAEL | ANDA 205659 | — | Feb 20, 2019 | |
| ACYCLOVIR | PADAGIS ISRAEL | ANDA 208702 | AB | Feb 04, 2019 | |
| ACYCLOVIR | CIPLA | ANDA 211794 | — | Jan 18, 2019 | |
| ACYCLOVIR | TORRENT | ANDA 209971 | AB | Jan 11, 2019 | |
| ACYCLOVIR | ALEMBIC | ANDA 209000 | AB | Apr 06, 2018 | |
| ACYCLOVIR×2 | YILING | ANDA 210401 | AB | Mar 07, 2018 | |
| ACYCLOVIR | COSETTE PHARMS NC | ANDA 205591 | — | Nov 13, 2017 | |
| ACYCLOVIR | CARLSBAD | ANDA 206261 | AB | Aug 16, 2017 | |
| ACYCLOVIR | CHARTWELL MOLECULAR | ANDA 206437 | — | Jul 31, 2017 | |
| ACYCLOVIR | GLENMARK SPECLT | ANDA 205510 | AB | Jul 31, 2017 | |
| ACYCLOVIR | SUN PHARMA CANADA | ANDA 205469 | AB | Dec 21, 2016 | |
| ACYCLOVIR | FOUGERA PHARMS INC | ANDA 206633 | AB | May 11, 2016 | |
| ACYCLOVIR | CADILA | ANDA 204313 | AB | Mar 25, 2016 | |
| ACYCLOVIR×2 | ZYDUS PHARMS | ANDA 204314 | AB | Aug 19, 2014 | |
| ACYCLOVIR | AMNEAL PHARMS | ANDA 204605 | AB | Jun 18, 2014 | |
| ACYCLOVIR | CADILA PHARMS LTD | ANDA 201445 | AB | Mar 06, 2014 | |
| ACYCLOVIR×2 | CADILA PHARMS LTD | ANDA 202168 | AB | Nov 15, 2013 | |
| ACYCLOVIR×2 | HETERO LABS LTD V | ANDA 203834 | AB | Oct 29, 2013 | |
| ACYCLOVIR | PHARMOBEDIENT | ANDA 202459 | AB | Apr 03, 2013 | |
| ACYCLOVIR×2 | APOTEX | ANDA 077309 | AB | Sep 29, 2005 | |
| ACYCLOVIR | APOTEX | ANDA 075677 | AB | Sep 28, 2005 | |
| ACYCLOVIR | HIKMA | ANDA 077026 | — | Jun 07, 2005 | |
| ACYCLOVIR×2 | CARLSBAD | ANDA 075382 | AB | Apr 30, 1999 | |
| ACYCLOVIR | REGCON HOLDINGS | ANDA 075090 | AB | Jan 26, 1999 | |
| ACYCLOVIR | RANBAXY | ANDA 074975 | — | Sep 30, 1998 | |
| ACYCLOVIR×2 | SUN PHARM INDS LTD | ANDA 074980 | — | Sep 30, 1998 | |
| ACYCLOVIR×2 | AUROBINDO PHARMA USA | ANDA 075211 | AB | Sep 28, 1998 | |
| ACYCLOVIR | WATSON LABS | ANDA 075101 | — | Apr 15, 1998 | |
| ACYCLOVIR | MYLAN | ANDA 074977 | — | Apr 13, 1998 | |
| ACYCLOVIR×2 | MYLAN | ANDA 074976 | — | Apr 13, 1998 | |
| ACYCLOVIR×2 | TEVA PHARMS | ANDA 075021 | — | Mar 18, 1998 | |
| ACYCLOVIR | TEVA PHARMS | ANDA 074914 | — | Nov 26, 1997 | |
| ACYCLOVIR×2 | STRIDES PHARMA INTL | ANDA 074946 | — | Nov 19, 1997 | |
| ACYCLOVIR | HERITAGE | ANDA 074889 | AB | Oct 31, 1997 | |
| ACYCLOVIR×2 | HERITAGE | ANDA 074891 | AB | Oct 31, 1997 | |
| ACYCLOVIR | ACTAVIS ELIZABETH | ANDA 074906 | — | Aug 26, 1997 | |
| ACYCLOVIR×2 | ACTAVIS ELIZABETH | ANDA 074870 | — | Jun 05, 1997 | |
| ACYCLOVIR | ACTAVIS MID ATLANTIC | ANDA 074738 | AB | Apr 28, 1997 | |
| ACYCLOVIR×2 | CHARTWELL MOLECULES | ANDA 074834 | — | Apr 24, 1997 | |
| ACYCLOVIR | AUROBINDO PHARMA USA | ANDA 074727 | — | Apr 22, 1997 | |
| ACYCLOVIR | CHARTWELL MOLECULES | ANDA 074872 | — | Apr 22, 1997 | |
| ACYCLOVIR | IVAX SUB TEVA PHARMS | ANDA 074674 | — | Apr 22, 1997 | |
| ACYCLOVIR | LEK PHARM | ANDA 074750 | — | Apr 22, 1997 | |
| ACYCLOVIR | ROXANE | ANDA 074570 | — | Apr 22, 1997 | |
| ACYCLOVIR | STRIDES PHARMA INTL | ANDA 074833 | — | Apr 22, 1997 | |
| ACYCLOVIR | TEVA | ANDA 074578 | AB | Apr 22, 1997 | |
| ACYCLOVIR | TEVA | ANDA 074828 | — | Apr 22, 1997 | |
| ACYCLOVIR×2 | IVAX SUB TEVA PHARMS | ANDA 074836 | — | Apr 22, 1997 | |
| ACYCLOVIR×2 | LEK PHARM | ANDA 074658 | — | Apr 22, 1997 | |
| ACYCLOVIR×3 | TEVA | ANDA 074556 | — | Apr 22, 1997 |
Marketing exclusivity (1)
- ODE-235Orphan-drug exclusivity (7 years)
Mar 29, 2026
3 mo ago
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8791127 | Mar 23, 2027 | in 9 mo | ProductU-1460 |
| 8747896 | Jun 03, 2027 | in 1 yr | ProductU-1460 |
| 8592434 | Jun 16, 2030 | in 4 yr 1 mo | ProductU-1460 |
Acyclovir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
