FDA Orange Book
Generic for Valcyte
Valcyte contains valganciclovir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Valcyte is valganciclovir. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Valcyte products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 50MG/ML | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | EQ 450MG BASE | Discontinued | None | 8 | AB |
NDA 022257, 021304, held by CHEPLAPHARM ARZNEIMITTEL GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic valganciclovir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 203511 | AB (A-rated, therapeutically equivalent) | November 4, 2014 | EQ 450MG BASE |
| STRIDES PHARMA INTERNATIONAL AG | 200790 | AB (A-rated, therapeutically equivalent) | November 4, 2014 | EQ 450MG BASE |
| HETERO LABS LTD UNIT V | 205166 | AB (A-rated, therapeutically equivalent) | March 18, 2016 | EQ 450MG BASE |
| AUROBINDO PHARMA LTD | 204750 | AB (A-rated, therapeutically equivalent) | March 31, 2016 | EQ 450MG BASE |
| ACTAVIS LABORATORIES FL INC | 205220 | AB (A-rated, therapeutically equivalent) | July 18, 2016 | 50MG/ML |
| DR REDDYS LABORATORIES LTD | 206876 | AB (A-rated, therapeutically equivalent) | December 12, 2017 | EQ 450MG BASE |
| AJANTA PHARMA LTD | 212234 | AB (A-rated, therapeutically equivalent) | December 26, 2019 | EQ 450MG BASE |
| AJANTA PHARMA LTD | 212890 | AB (A-rated, therapeutically equivalent) | January 13, 2020 | 50MG/ML |
| GRANULES PHARMACEUTICALS INC | 213306 | AB (A-rated, therapeutically equivalent) | January 31, 2020 | 50MG/ML |
| MSN LABORATORIES PRIVATE LTD | 210169 | AB (A-rated, therapeutically equivalent) | February 17, 2022 | 50MG/ML |
| HETERO LABS LTD UNIT V | 211475 | AB (A-rated, therapeutically equivalent) | October 4, 2022 | 50MG/ML |
| AUROBINDO PHARMA LTD | 215124 | AB (A-rated, therapeutically equivalent) | November 17, 2022 | 50MG/ML |
| APPCO PHARMA LLC | 216317 | AB (A-rated, therapeutically equivalent) | April 11, 2023 | 50MG/ML |
| SOMERSET THERAPEUTICS LLC | 212876 | AB (A-rated, therapeutically equivalent) | June 11, 2024 | EQ 450MG BASE |
| SPH ZHONGXI PHARMACEUTICAL CO LTD | 218027 | AB (A-rated, therapeutically equivalent) | April 16, 2025 | EQ 450MG BASE |
| MICRO LABS LTD | 218838 | AB (A-rated, therapeutically equivalent) | March 19, 2026 | 50MG/ML |
Valcyte patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9642911 | December 11, 2027 | Drug product | None | 022257 |
| 8889109 | December 11, 2027 | Drug product | None | 022257 |
Valcyte NDC codes
Questions
Is there a generic for Valcyte?
Yes. The generic name for Valcyte is valganciclovir. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Valcyte?
The active ingredient in Valcyte is valganciclovir, per the FDA Orange Book.
When does the Valcyte patent expire?
The last patent listed for Valcyte in the Orange Book expires December 11, 2027. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.