FDA Orange Book
Generic for Entereg
Entereg contains alvimopan. 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 Entereg is alvimopan. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Entereg products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 12MG | Discontinued | None | 3 | AB |
NDA 021775, held by CUBIST PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic alvimopan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 208295 | AB (A-rated, therapeutically equivalent) | December 19, 2019 | 12MG |
| PH HEALTH LTD | 216843 | AB (A-rated, therapeutically equivalent) | January 24, 2023 | 12MG |
| HIKMA PHARMACEUTICALS USA INC | 217753 | AB (A-rated, therapeutically equivalent) | August 31, 2023 | 12MG |
Entereg patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8946262 | February 12, 2030 | Method of use | U-1655 | 021775 |
Questions
Is there a generic for Entereg?
Yes. The generic name for Entereg is alvimopan. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Entereg?
The active ingredient in Entereg is alvimopan, per the FDA Orange Book.
When does the Entereg patent expire?
The last patent listed for Entereg in the Orange Book expires February 12, 2030. 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.