FDA Orange Book
Generic for Coreg CR
Coreg CR contains carvedilol. 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 Coreg CR is carvedilol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Coreg CR and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Coreg CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 10MG | Marketed (Rx) | AB | 2 | AB |
| capsule, extended release, oral | 20MG | Marketed (Rx) | AB | 2 | AB |
| capsule, extended release, oral | 40MG | Marketed (Rx) | AB | 2 | AB |
| capsule, extended release, oral | 80MG | Marketed (Rx) | AB | 2 | AB |
NDA 022012, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carvedilol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 090132 | AB (A-rated, therapeutically equivalent) | October 25, 2017 | 10MG, 20MG, 40MG, 80MG |
| IMPAX LABORATORIES INC | 204717 | AB (A-rated, therapeutically equivalent) | May 7, 2018 | 10MG, 20MG, 40MG, 80MG |
Coreg CR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8101209 | September 11, 2025 | Drug product | None | 022012 |
| 8101209*PED | March 11, 2026 | Method of use | None | 022012 |
Coreg CR NDC codes
Questions
Is there a generic for Coreg CR?
Yes. The generic name for Coreg CR is carvedilol. 2 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 Coreg CR?
The active ingredient in Coreg CR is carvedilol, per the FDA Orange Book.
When does the Coreg CR patent expire?
The last patent listed for Coreg CR in the Orange Book expires March 11, 2026. 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.