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 Generics, Hikma, Lupin, Mylan, Pliva Hrvatska Doo, Rubicon, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Zydus Pharms Usa Inc, Woodward, Impax Labs Inc, and Sun Pharm Industries, and is included in twenty-one NDAs. There are two patents 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-two suppliers are listed for this compound.

Summary for carvedilol

US Patents:	2
Tradenames:	4
Applicants:	20
NDAs:	21
Drug Master File Entries:	37
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	181
Patent Applications:	6,640
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
Tanta University	N/A
Wonju Severance Christian Hospital	Phase 4
Samsung Medical Center	Phase 4

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

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
Teva	CARVEDILOL	carvedilol	TABLET;ORAL	076373-001	Sep 5, 2007	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Beximco Usa	CARVEDILOL	carvedilol	TABLET;ORAL	078384-004	Sep 5, 2007	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-002	Oct 25, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Woodward	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	See Plans and Pricing	See Plans and Pricing
Woodward	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	See Plans and Pricing	See Plans and Pricing
Woodward	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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