Carvedilol - Generic Drug Details

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What are the generic sources for carvedilol and what is the scope of freedom to operate?

Carvedilol is the generic ingredient in four branded drugs marketed by ACI, Aurobindo Pharma, Beximco Usa, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma, Lupin, Mylan, Pliva Hrvatska Doo, Rubicon, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Zydus Pharms Usa Inc, Waylis Therap, Impax Labs Inc, and Sun Pharm Industries, and is included in twenty-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-seven drug master file entries for carvedilol. Forty-three suppliers are listed for this compound.

Summary for carvedilol

US Patents:	1
Tradenames:	4
Applicants:	20
NDAs:	21
Drug Master File Entries:	37
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	188
Patent Applications:	5,905
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for carvedilol
Drug Sales Revenues:	Drug sales revenues for carvedilol
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carvedilol
What excipients (inactive ingredients) are in carvedilol?	carvedilol excipients list
DailyMed Link:	carvedilol at DailyMed

See drug prices for carvedilol

Drug Sales Revenue Trends for carvedilol

See drug sales revenues for carvedilol

Recent Clinical Trials for carvedilol

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

Sponsor	Phase
VA Office of Research and Development	Phase 3
Tanta University	Early Phase 1
West China Hospital	N/A

See all carvedilol clinical trials

Pharmacology for carvedilol

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

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

US Patents and Regulatory Information for carvedilol

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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
Sun Pharm Inds Inc	CARVEDILOL	carvedilol	TABLET;ORAL	077346-003	Sep 5, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aci	CARVEDILOL	carvedilol	TABLET;ORAL	078786-002	Dec 22, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	CARVEDILOL	carvedilol	TABLET;ORAL	077316-001	Sep 5, 2007		DISCN	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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