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Last Updated: January 27, 2023

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 are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carvedilol phosphate has fifty-one patent family members in seventeen countries.

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

Recent Clinical Trials for carvedilol phosphate

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

SponsorPhase
GlaxoSmithKlinePhase 1
GlaxoSmithKlinePhase 1/Phase 2
University of Minnesota - Clinical and Translational Science InstitutePhase 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 022012-002 Oct 20, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm Industries CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132-002 Oct 25, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs Inc CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 204717-002 May 7, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for carvedilol phosphate

Country Patent Number Title Estimated Expiration
Mexico PA04012923 SALES DE FOSFATO DE CARVEDILOL Y/O SOLVATOS DE LAS MISMAS, COMPOSICIONES CORRESPONDIENTES Y/O METODOS DE TRATAMIENTO. (CARVEDILOL PHOSPHATE SALTS AND/OR SOLVATES THEREOF, CORRESPONDINQ COMPOSITIONS, AND/OR METHODS OF TREATMENT.) See Plans and Pricing
South Korea 20100063825 GALENIC MICROPARTICULATE ORAL FORMULATION FOR DELAYED AND CONTROLLED RELEASE OF PHARMACEUTICAL ACTIVE PRINCIPLES See Plans and Pricing
South Africa 200410011 Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
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Mallinckrodt
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.