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Last Updated: December 5, 2019

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Carvedilol phosphate - Generic Drug Details

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What are the generic 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 Smithkline Beecham, 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 thirty-seven drug master file entries for carvedilol phosphate. Four 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 Minnesota - Clinical and Translational Science InstitutePhase 1/Phase 2
GlaxoSmithKlinePhase 1/Phase 2

See all carvedilol phosphate clinical trials

Recent Litigation for carvedilol phosphate

Identify potential future generic entrants

District Court Litigation
Case NameDate
GlaxoSmithKline LLC v. Glenmark Pharmaceuticals Inc., USA2014-07-03
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc.2014-07-03
FLAMEL TECHNOLOGIES S.A. v. LUPIN LIMITED2011-05-04

See all carvedilol phosphate litigation

Synonyms for carvedilol phosphate
(2RS)-1-(9H-Carbazol-4-yloxy)-3-((2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol phosphate salt (1:1) hemihydrate
1-9H-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol phosphate hemihydrate
1196658-85-1
2-Propanol, 1-(9H-carbazol-4-yloxy)-3-((2-(2-methoxyphenoxy)ethyl)amino)-, phosphate (salt), hydrate (2:2:1)
2-Propanol, 1-(9H-carbazol-4-yloxy)-3-((2-(2-methoxyphenoxy)ethyl)amino)-, phosphate, hydrate (1:1:1)
309C892
610309-89-2
BCP28563
C24H31N2O9P
Carvedilol phosphate hemihydrate
Carvedilol phosphate monohydrate
Coreg CR
JAYBFQXVKDGMFT-UHFFFAOYSA-N
LS-186601
SCHEMBL599530
SK&F-105517-D
SKF 105517D
W0023
Paragraph IV (Patent) Challenges for CARVEDILOL PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
COREG CR CAPSULE, EXTENDED RELEASE;ORAL carvedilol phosphate 022012 2008-03-18
COREG CR CAPSULE, EXTENDED RELEASE;ORAL carvedilol phosphate 022012 2007-12-21
COREG CR CAPSULE, EXTENDED RELEASE;ORAL carvedilol phosphate 022012 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
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Industries CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 090132-002 Oct 25, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 204717-004 May 7, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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McKinsey
Dow

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