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 Waylis Therap, 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. Ten 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:	10
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	5
Patent Applications:	191
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	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

Anatomical Therapeutic Chemical (ATC) Classes for carvedilol phosphate

C07AG	Alpha and beta blocking agents
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-002	Oct 25, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-004	Oct 25, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-002	May 7, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-003	May 7, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-004	May 7, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for carvedilol phosphate

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Country	Patent Number	Title	Estimated Expiration
China	1976682	Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active component	⤷ Sign Up
China	1568181	Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles	⤷ Sign Up
China	100341493		⤷ Sign Up
Brazil	0213175	Forma galênica oral macroparticular para a liberação retardada e controlada de princìpios ativos farmacêuticos	⤷ Sign Up
Japan	2005506336		⤷ Sign Up
South Korea	101078636		⤷ Sign Up
Brazil	PI0213175	forma galênica oral macroparticulada para a liberação retardada e controlada de um princípios ativos farmacêuticos e uso de microcápsulas "reservatório"	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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