FDA Orange Book · active-ingredient family
Valganciclovir hydrochloride
Valganciclovir hydrochloride is approved as 2 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VALCYTE · NDA 022257
2
Brand (NDA)
18
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALCYTERLD | CHEPLAPHARM | NDA 022257 | AB | Aug 28, 2009 | |
| VALCYTERLD | CHEPLAPHARM | NDA 021304 | AB | Mar 29, 2001 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALGANCICLOVIR HYDROCHLORIDE | MICRO LABS | ANDA 218838 | AB | Mar 19, 2026 | |
| VALGANCICLOVIR HYDROCHLORIDE | SPH ZHONGXI PHARM | ANDA 218027 | AB | Apr 16, 2025 | |
| VALGANCICLOVIR HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 212876 | AB | Jun 11, 2024 | |
| VALGANCICLOVIR HYDROCHLORIDE | APPCO | ANDA 216317 | AB | Apr 11, 2023 | |
| VALGANCICLOVIR HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 215124 | AB | Nov 17, 2022 | |
| VALGANCICLOVIR HYDROCHLORIDE | HETERO LABS LTD V | ANDA 211475 | AB | Oct 04, 2022 | |
| VALGANCICLOVIR HYDROCHLORIDE | MSN | ANDA 210169 | AB | Feb 17, 2022 | |
| VALGANCICLOVIR HYDROCHLORIDE | PHARMOBEDIENT | ANDA 205151 | — | Mar 03, 2021 | |
| VALGANCICLOVIR HYDROCHLORIDE | GRANULES | ANDA 213306 | AB | Jan 31, 2020 | |
| VALGANCICLOVIR HYDROCHLORIDE | AJANTA PHARMA LTD | ANDA 212890 | AB | Jan 13, 2020 | |
| VALGANCICLOVIR HYDROCHLORIDE | AJANTA PHARMA LTD | ANDA 212234 | AB | Dec 26, 2019 | |
| VALGANCICLOVIR HYDROCHLORIDE | CIPLA | ANDA 209672 | — | Nov 09, 2018 | |
| VALGANCICLOVIR HYDROCHLORIDE | DR REDDYS | ANDA 206876 | AB | Dec 12, 2017 | |
| VALGANCICLOVIR HYDROCHLORIDE | ACTAVIS LABS FL INC | ANDA 205220 | AB | Jul 18, 2016 | |
| VALGANCICLOVIR HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 204750 | AB | Mar 31, 2016 | |
| VALGANCICLOVIR HYDROCHLORIDE | HETERO LABS LTD V | ANDA 205166 | AB | Mar 18, 2016 | |
| VALGANCICLOVIR HYDROCHLORIDE | DR REDDYS | ANDA 203511 | AB | Nov 04, 2014 | |
| VALGANCICLOVIR HYDROCHLORIDE | STRIDES PHARMA INTL | ANDA 200790 | AB | Nov 04, 2014 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9642911 | Dec 11, 2027 | in 1 yr 6 mo | Product |
| 8889109 | Dec 11, 2027 | in 1 yr 6 mo | Product |
Valganciclovir hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
