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 nine drug master file entries for carvedilol phosphate. Seven 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:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	5
Patent Applications:	237
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
GlaxoSmithKline	Phase 1/Phase 2
University of Minnesota - Clinical and Translational Science Institute	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	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
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing			Y	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
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-002	May 7, 2018	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 phosphate

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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	See Plans and Pricing	See Plans and Pricing
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	See Plans and Pricing	See Plans and Pricing
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	See Plans and Pricing	See Plans and Pricing
>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
Mexico	PA04012923	SALES DE FOSFATO DE CARVEDILOL Y/O SOLVATOS DE LAS MISMAS, COMPOSICIONES CORRESPONDIENTES Y/O METODOS DE TRATAMIENTO. (CARVEDILOL PHOSPHATE SALTS AND/OR SOLVATES THEREOF, CORRESPONDINQ COMPOSITIONS, AND/OR METHODS OF TREATMENT.)	See Plans and Pricing
South Korea	20100063825	GALENIC MICROPARTICULATE ORAL FORMULATION FOR DELAYED AND CONTROLLED RELEASE OF PHARMACEUTICAL ACTIVE PRINCIPLES	See Plans and Pricing
South Africa	200410011	Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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