FDA Orange Book
Generic for Norvir
Norvir contains ritonavir. 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 Norvir is ritonavir. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Norvir products the Orange Book lists.
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Norvir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 1 | None |
| capsule, oral | 100MG | Discontinued | None | 1 | None |
| powder, oral | 100MG/PACKET | Marketed (Rx) | None | 0 | None |
| solution, oral | 80MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Marketed (Rx) | AB | 4 | AB |
NDA 020680, 020945, 209512, 020659, 022417, held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ritonavir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CIPLA LTD | 202573 | AB (A-rated, therapeutically equivalent) | January 15, 2015 | 100MG |
| AUROBINDO PHARMA LTD | 206614 | AB (A-rated, therapeutically equivalent) | September 17, 2018 | 100MG |
| HETERO LABS LTD UNIT III | 204587 | AB (A-rated, therapeutically equivalent) | September 17, 2018 | 100MG |
| CIPLA LTD | 203759 | AB (A-rated, therapeutically equivalent) | May 10, 2022 | 100MG |
| QUAGEN PHARMACEUTICALS LLC | 205024 | None (No TE code listed) | February 16, 2024 | 100MG, 100MG |
Norvir NDC codes
Questions
Is there a generic for Norvir?
Yes. The generic name for Norvir is ritonavir. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Norvir products the Orange Book lists.
What is the generic name for Norvir?
The active ingredient in Norvir is ritonavir, 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.