FDA Orange Book
Generic for Viramune XR
Viramune XR contains nevirapine. 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 Viramune XR is nevirapine. 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 Viramune XR products the Orange Book lists.
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Viramune XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 400MG | Discontinued | None | 3 | AB |
NDA 201152, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nevirapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 203411 | AB (A-rated, therapeutically equivalent) | April 3, 2014 | 400MG |
| MYLAN PHARMACEUTICALS INC | 205651 | AB (A-rated, therapeutically equivalent) | October 27, 2014 | 400MG |
| MACLEODS PHARMACEUTICALS LTD | 206879 | AB (A-rated, therapeutically equivalent) | October 6, 2017 | 400MG |
Viramune XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8460704 | March 12, 2029 | Method of use | U-1409 | 201152 |
Questions
Is there a generic for Viramune XR?
Yes. The generic name for Viramune XR is nevirapine. 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 Viramune XR products the Orange Book lists.
What is the generic name for Viramune XR?
The active ingredient in Viramune XR is nevirapine, per the FDA Orange Book.
When does the Viramune XR patent expire?
The last patent listed for Viramune XR in the Orange Book expires March 12, 2029. 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.