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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 carvedilol phosphate 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. Five 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
Suppliers / Packagers:	5
Bulk Api Vendors:	10
Clinical Trials:	5
Patent Applications:	46
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carvedilol phosphate
DailyMed Link:	carvedilol phosphate at DailyMed

Pharmacology for carvedilol phosphate

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

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

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
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-001	Oct 25, 2017	AB	RX	No	No
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	Yes					Y
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-003	Oct 25, 2017	AB	RX	No	No
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	AB	RX	Yes	No					Y
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	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
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006

International Patents for carvedilol phosphate

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	200500091
Canada	2563689
South Korea	101078636
Mexico	PA04012923
Japan	2005533823