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Last Updated: April 22, 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 freedom to operate?

Carvedilol phosphate is the generic ingredient in two branded drugs marketed by Impax Labs Inc, Sun Pharm Industries, and Woodward, 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. Eight suppliers are listed for this compound.

Recent Clinical Trials for carvedilol phosphate

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

SponsorPhase
GlaxoSmithKlinePhase 1
University of MinnesotaPhase 1/Phase 2
GlaxoSmithKlinePhase 1/Phase 2

See all carvedilol phosphate clinical trials

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
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Impax Labs Inc CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 204717-001 May 7, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132-001 Oct 25, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm Industries CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132-004 Oct 25, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for carvedilol phosphate

Country Patent Number Title Estimated Expiration
China 1568181 Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles ⤷  Try a Trial
Spain 2661723 ⤷  Try a Trial
South Korea 20040073433 ⤷  Try a Trial
Australia 2002362712 Galenic microparticulate oral formulation ⤷  Try a Trial
Canada 2463134 FORME GALENIQUE ORALE MICROPARTICULAIRE (GALENIC MICROPARTICULATE ORAL FORMULATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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