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Last Updated: November 21, 2024

CARVEDILOL PHOSPHATE - Generic Drug Details


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What are the generic drug sources for carvedilol phosphate and what is the scope of patent protection?

Carvedilol phosphate is the generic ingredient in two branded drugs marketed by Impax Labs Inc, Sun Pharm Industries, and Waylis Therap, and is included in three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carvedilol phosphate has twenty-four patent family members in fourteen countries.

There are nine drug master file entries for carvedilol phosphate. Ten suppliers are listed for this compound.

Summary for CARVEDILOL PHOSPHATE
Recent Clinical Trials for CARVEDILOL PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 1
University of Minnesota - Clinical and Translational Science InstitutePhase 1/Phase 2
University of MinnesotaPhase 1/Phase 2

See all CARVEDILOL PHOSPHATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CARVEDILOL PHOSPHATE
Paragraph IV (Patent) Challenges for CARVEDILOL PHOSPHATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COREG CR Extended-release Capsules carvedilol phosphate 10 mg and 20 mg 022012 1 2008-03-18
COREG CR Extended-release Capsules carvedilol phosphate 40 mg 022012 1 2007-12-21
COREG CR Extended-release Capsules carvedilol phosphate 80 mg 022012 1 2007-11-19

US Patents and Regulatory Information for CARVEDILOL PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm Industries CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132-002 Oct 25, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132-004 Oct 25, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 204717-002 May 7, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CARVEDILOL PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 ⤷  Sign Up ⤷  Sign Up
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 ⤷  Sign Up ⤷  Sign Up
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 ⤷  Sign Up ⤷  Sign Up
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 ⤷  Sign Up ⤷  Sign Up
Waylis Therap COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CARVEDILOL PHOSPHATE

Country Patent Number Title Estimated Expiration
China 1976682 Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active component ⤷  Sign Up
China 1568181 Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles ⤷  Sign Up
China 100341493 ⤷  Sign Up
Brazil 0213175 Forma galênica oral macroparticular para a liberação retardada e controlada de princìpios ativos farmacêuticos ⤷  Sign Up
Japan 2005506336 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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