CARVEDILOL PHOSPHATE - Generic Drug Details

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 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.

Summary for CARVEDILOL PHOSPHATE

International Patents:	24
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	5
Patent Applications:	199
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARVEDILOL PHOSPHATE
What excipients (inactive ingredients) are in CARVEDILOL PHOSPHATE?	CARVEDILOL PHOSPHATE excipients list
DailyMed Link:	CARVEDILOL PHOSPHATE at DailyMed

Recent Clinical Trials for CARVEDILOL PHOSPHATE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
GlaxoSmithKline	Phase 1/Phase 2
University of Minnesota - Clinical and Translational Science Institute	Phase 1/Phase 2

See all CARVEDILOL PHOSPHATE clinical trials

Pharmacology for CARVEDILOL PHOSPHATE

Drug Class	alpha-Adrenergic Blocker beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists

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	022012-003	Oct 20, 2006	AB	RX	Yes	Yes					Y
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	AB	RX	Yes	No					Y
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-002	May 7, 2018	AB	RX	No	No
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-004	May 7, 2018	AB	RX	No	No
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No					Y

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	022012-001	Oct 20, 2006
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006

International Patents for CARVEDILOL PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04003367	FORMULACION ORAL MICROPARTICULADA GALENICA PARA LA LIBERACION RETRASADA Y CONTROLADA DE PRINCIPIOS ACTIVOS FARMACEUTICOS. (GALENIC MICROPARTICULATE ORAL FORMULATION.)
France	2830447	FORME GALENIQUE ORALE MICROPARTICULAIRE POUR LA LIBERATION RETARDEE ET CONTROLEE DE PRINCIPES ACTIFS PHARMACEUTIQUES (Microparticulate oral formulation for controlled, retarded release of drug absorbed from upper gastrointestinal tract, having combination of pH dependent and time dependent release mechanisms to guarantee absorption)
Hong Kong	1072898	Galenic microparticulate oral formulation for delayed and controlled release of pharmaceutical active principles
European Patent Office	1434572	FORME GALENIQUE ORALE MICROPARTICULAIRE POUR LA LIBERATION RETARDEE ET CONTROLEE DE PRINCIPES ACTIFS PHARMACEUTIQUES (MICROPARTICULATE ORAL DOSAGE FORM FOR THE DELAYED AND CONTROLLED RELEASE OF PHARMACEUTICAL ACTIVE INGREDIENTS)
Japan	2005506336