FDA Orange Book · active-ingredient family
Valacyclovir hydrochloride
Valacyclovir hydrochloride is approved as 1 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VALTREX · NDA 020487
1
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALTREXRLD×2 | GLAXOSMITHKLINE | NDA 020487 | AB | Jun 23, 1995 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE×2 | YILING | ANDA 209553 | AB | Mar 18, 2020 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | ZYDUS LIFESCIENCES | ANDA 079137 | AB | Dec 29, 2017 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | HETERO LABS LTD V | ANDA 203047 | AB | Apr 08, 2015 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | APOTEX | ANDA 090500 | — | Apr 04, 2014 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | JUBILANT GENERICS | ANDA 201506 | AB | Apr 03, 2012 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | WATSON LABS INC | ANDA 090370 | — | Mar 16, 2011 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | AIPING PHARM INC | ANDA 077478 | — | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | AUROBINDO PHARMA | ANDA 090682 | AB | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | CHARTWELL RX | ANDA 090216 | AB | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | CIPLA | ANDA 077135 | — | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | HIKMA | ANDA 078656 | — | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | MYLAN PHARMS INC | ANDA 078518 | AB | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | PHARMOBEDIENT | ANDA 078070 | — | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | RISING | ANDA 079012 | AB | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | TEVA PHARMS | ANDA 077655 | — | May 24, 2010 | |
| VALACYCLOVIR HYDROCHLORIDE×2 | SUN PHARM INDS LTD | ANDA 076588 | AB | Jan 31, 2007 |
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.
Valacyclovir hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
