FDA Orange Book
Generic for Intelence
Intelence contains etravirine. 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 Intelence is etravirine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Intelence products the Orange Book lists.
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Intelence products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 200MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
NDA 022187, held by JANSSEN RESEARCH AND DEVELOPMENT LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic etravirine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 214196 | AB (A-rated, therapeutically equivalent) | June 14, 2021 | 100MG, 200MG |
| PHARMOBEDIENT CONSULTING LLC | 215402 | AB (A-rated, therapeutically equivalent) | April 13, 2022 | 100MG, 200MG |
| BIONPHARMA INC | 219152 | AB (A-rated, therapeutically equivalent) | October 2, 2025 | 100MG, 200MG |
Intelence NDC codes
Questions
Is there a generic for Intelence?
Yes. The generic name for Intelence is etravirine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Intelence products the Orange Book lists.
What is the generic name for Intelence?
The active ingredient in Intelence is etravirine, 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.