FDA Orange Book · active-ingredient family
Carvedilol phosphate
Carvedilol phosphate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COREG CR · NDA 022012
1
Brand (NDA)
2
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COREG CRRLD×4 | WAYLIS THERAP | NDA 022012 | AB | Oct 20, 2006 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE×4 | IMPAX LABS INC | ANDA 204717 | AB | May 07, 2018 | |
| CARVEDILOL PHOSPHATE×4 | SUN PHARM INDUSTRIES | ANDA 090132 | AB | Oct 25, 2017 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8101209 | Sep 11, 2025 | 9 mo ago | Product |
| 8101209*PED | Mar 11, 2026 | 3 mo ago |
Carvedilol phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
