FDA Orange Book
Generic for Copegus
Copegus contains ribavirin. 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 Copegus is ribavirin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Copegus products the Orange Book lists.
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Copegus products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Discontinued | None | 3 | AB |
| tablet, oral | 400MG | Discontinued | None | 0 | None |
NDA 021511, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ribavirin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 077094 | AB (A-rated, therapeutically equivalent) | December 5, 2005 | 200MG |
| SANDOZ INC | 077743 | AB (A-rated, therapeutically equivalent) | October 3, 2006 | 200MG |
| AUROBINDO PHARMA LTD | 079111 | AB (A-rated, therapeutically equivalent) | September 17, 2009 | 200MG |
Questions
Is there a generic for Copegus?
Yes. The generic name for Copegus is ribavirin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Copegus products the Orange Book lists.
What is the generic name for Copegus?
The active ingredient in Copegus is ribavirin, 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.