FDA Orange Book · active-ingredient family
Carvedilol phosphate
Carvedilol phosphate: 1 brand, 2 generics; first approved Oct 20, 2006; generic available.
Generic available
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
2
Next patent expiry
Sep 11, 2025
1 yr ago
Brand (NDA) products
Originator applications
- COREG CRRLDWAYLIS THERAPNDA 02201220064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- CARVEDILOL PHOSPHATEIMPAX LABS INCANDA 20471720184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - CARVEDILOL PHOSPHATESUN PHARM INDUSTRIESANDA 09013220174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 40MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8101209 | 1 yr ago | Product | |
| 8101209*PED | 6 mo ago |
Approval history
FDA approval span
First approval
20 yr 2 mo ago
Most recent approval
8 yr 5 mo ago
Approvals span 2006–2018 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Carvedilol phosphate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
