FDA Orange Book
Generic for Cligavyx
Cligavyx contains fulvestrant. 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 Cligavyx is fulvestrant. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
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Cligavyx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular | 250MG/5ML (50MG/ML) | Marketed (Rx) | None | 12 | AO |
NDA 210063, held by AVYXA HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fulvestrant
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 210044 | AO (A-rated, therapeutically equivalent) | March 4, 2019 | 250MG/5ML (50MG/ML) |
| SANDOZ INC | 205935 | AO (A-rated, therapeutically equivalent) | May 14, 2019 | 250MG/5ML (50MG/ML) |
| GLENMARK PHARMACEUTICALS INC USA | 207754 | AO (A-rated, therapeutically equivalent) | August 22, 2019 | 250MG/5ML (50MG/ML) |
| SAGENT PHARMACEUTICALS INC | 205871 | AO (A-rated, therapeutically equivalent) | August 22, 2019 | 250MG/5ML (50MG/ML) |
| HBT LABS INC | 209714 | AO (A-rated, therapeutically equivalent) | November 21, 2019 | 250MG/5ML (50MG/ML) |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO LTD | 211422 | AO (A-rated, therapeutically equivalent) | February 7, 2020 | 250MG/5ML (50MG/ML) |
| DR REDDYS LABORATORIES LTD | 209246 | AO (A-rated, therapeutically equivalent) | August 7, 2020 | 250MG/5ML (50MG/ML) |
| ACCORD HEALTHCARE INC | 211689 | AO (A-rated, therapeutically equivalent) | November 17, 2020 | 250MG/5ML (50MG/ML) |
| ZYDUS PHARMACEUTICALS USA INC | 215234 | AO (A-rated, therapeutically equivalent) | July 29, 2021 | 250MG/5ML (50MG/ML) |
| XIROMED PHARMA ESPANA SL | 213553 | AO (A-rated, therapeutically equivalent) | August 13, 2021 | 250MG/5ML (50MG/ML) |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 214682 | AO (A-rated, therapeutically equivalent) | February 10, 2022 | 250MG/5ML (50MG/ML) |
| ALEMBIC PHARMACEUTICALS LTD | 215077 | AO (A-rated, therapeutically equivalent) | December 22, 2022 | 250MG/5ML (50MG/ML) |
Cligavyx NDC codes
Questions
Is there a generic for Cligavyx?
Yes. The generic name for Cligavyx is fulvestrant. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
What is the generic name for Cligavyx?
The active ingredient in Cligavyx is fulvestrant, per the FDA Orange Book.
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.