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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 thirty-seven drug master file entries for carvedilol phosphate. Six suppliers are listed for this compound.

Summary for carvedilol phosphate

International Patents:	51
US Patents:	2
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	37
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	5
Patent Applications:	111
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
University of Minnesota - Clinical and Translational Science Institute	Phase 1/Phase 2
GlaxoSmithKline	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	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
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No					Y
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	Yes					Y
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-002	May 7, 2018	AB	RX	No	No
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-001	Oct 25, 2017	AB	RX	No	No

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
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	022012-004	Oct 20, 2006

International Patents for carvedilol phosphate

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004002419
Japan	2011088917
World Intellectual Property Organization (WIPO)	03030878
Norway	20050427