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Carvedilol - Generic Drug Details

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

Carvedilol is the generic ingredient in four branded drugs marketed by Apotex Inc, Aurobindo Pharma, Beximco Usa, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Generics, Hikma, Lupin, Mylan, Pliva Hrvatska Doo, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Wockhardt Ltd, Zydus Pharms Usa Inc, Smithkline Beecham, 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. Fifty-four suppliers are listed for this compound.

Summary for carvedilol

US Patents:	2
Tradenames:	4
Applicants:	20
NDAs:	21
Drug Master File Entries:	37
Suppliers / Packagers:	54
Bulk Api Vendors:	101
Clinical Trials:	137
Patent Applications:	6,421
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for carvedilol
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carvedilol
DailyMed Link:	carvedilol at DailyMed

Pharmacology for carvedilol

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

Synonyms for carvedilol

(+-)-1-(Carbazol-4-yloxy)-3-((2-(o-methoxyphenoxy)ethyl)amino)-2-propanol

(+-)-1-Carbazol-4-yloxy)-3-((2-(o-methoxyphenoxy)ethyl)amino)-2-propanol

(+/-)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol

[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl][2-(2-methoxyphenoxy)ethyl]amine

1-((9H-Carbazol-4-yl)oxy)-3-((2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol

1-(9H-carbazol-4-yloxy)-3-[(2-{[2-(methyloxy)phenyl]oxy}ethyl)amino]propan-2-ol

1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol

1-(9H-carbazol-4-yloxy)-3-[2-(2-methoxy-phenoxy)-ethylamino]-propan-2-ol

1-(9H-carbazol-4-yloxy)-3-[2-(2-methoxyphenoxy)ethylamino]propan-2-ol

1-(9H-carbazol-4-yloxy)-3-{[2-(2-methoxyphenoxy)ethyl]amino}propan-2-ol

102641-EP2270011A1

102641-EP2272841A1

102641-EP2275420A1

102641-EP2298764A1

102641-EP2298765A1

102641-EP2301936A1

107741-96-8

2-Propanol, 1-(9H-carbazol-4-yloxy)-3-((2-(2-methoxyphenoxy)ethyl)amino)-, (+-)-

72956-09-3

956C093

AB0008431

AB00639903_10

AB00639903_11

AB00639903_12

AB00639903-07

AB00639903-09

AB1004830

AC-1641

AC1L1E0B

AK163147

AKOS005554967

AN-14749

API0001873

Artist

Artist (TN)

Atlana Pharma brand of carvedilol

AX8120145

BBL029064

BC204100

BCP0726000253

BCP9000493

BDBM25759

BG0129

Bio-0014

BM 14,190

BM 14.190

BM 14190

BM-14-190

BM-14.190

BM-14190

BRD-A10977446-001-04-8

BRD-A10977446-045-01-1

C-21835

C06875

C24H26N2O4

Carloc (TN)

Carvedilol (JAN/USAN/INN)

Carvedilol [USAN:INN:BAN:JAN]

Carvedilol [USAN:USP:INN:BAN:JAN]

Carvedilol 1.0 mg/ml in Methanol

Carvedilol for system suitability, European Pharmacopoeia (EP) Reference Standard

carvedilol HCl

Carvedilol hydrochloride

Carvedilol phosphate

carvedilol, (+-)-isomer

carvedilol, (R)-isomer

carvedilol, (S)-isomer

Carvedilol, >=98% (HPLC), solid

carvedilol, 14C-labeled

Carvedilol, European Pharmacopoeia (EP) Reference Standard

Carvedilol, pharmaceutical secondary standard; traceable to USP and PhEur

Carvedilol, United States Pharmacopeia (USP) Reference Standard

Carvedilolum

Carvedilolum [Latin]

carvediol

CC-25436

CCG-100917

CCG-207952

CHEBI:3441

CHEMBL723

Coreg

Coreg (TN)

Coreg CR

Coropres

Coropress

CPD000449280

CS-1194

CTK3J2232

D00255

D0W9LX

DB01136

Dibloc

Dilatrend

Dilatrend (TN)

DQ 2466

DQ-2466

DTXSID8022747

EG-P042

Eucardic

Eucardic (TN)

FT-0603059

FT-0652640

GlaxoSmithKline brand of carvedilol

GTPL551

HMS2051N03

HMS2089B09

HMS2093E12

HMS3261E15

HMS3269N11

HMS3393N03

HMS3655O14

HSDB 7044

HY-B0006

I06-0064

I06-1477

J10039

KB-75594

KBio2_002145

KBio2_004713

KBio2_007281

KBio3_002323

KBioGR_001252

KBioSS_002145

Kredex

KS-00000XRT

KS-1037

KSC492E3F

L001243

Lakeside brand of carvedilol

LP00347

LS-121875

MCULE-7944987271

MFCD00864692

MLS000758299

MLS000759508

MLS001424092

MLS006011886

MolPort-003-666-814

NC00167

NCGC00167832-01

NCGC00167832-02

NCGC00167832-03

NCGC00167832-04

NCGC00261032-01

NSC-758694

NSC758694

OGHNVEJMJSYVRP-UHFFFAOYSA-N

Pharmakon1600-01504257

PL008198

PL039781

PL068260

PubChem18218

Q-200801

Querto

Roche brand of carvedilol

RTR-037608

s1831

SAM001246736

SAM001247021

SBI-0206771.P001

SC-13445

SCHEMBL10082334

SCHEMBL13287211

SCHEMBL22293

SK&F-105517

SKF 105517

SMR000449280

SPBio_001885

Spectrum_001665

Spectrum2_001673

Spectrum3_001182

Spectrum4_000636

Spectrum5_001436

SR-01000759289

SR-01000759289-9

ST24036957

STK621453

TL8005080

Tox21_500347

TR-037608

W-5131

Z2786051695

US Patents and Regulatory Information for carvedilol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	CARVEDILOL	carvedilol	TABLET;ORAL	076649-002	Sep 5, 2007	AB	RX	No	No
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	AB	RX	Yes	Yes
Glenmark Generics	CARVEDILOL	carvedilol	TABLET;ORAL	078251-002	Sep 5, 2007	AB	RX	No	No
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	AB	RX	Yes	No					Y
Dr Reddys Labs Ltd	CARVEDILOL	carvedilol	TABLET;ORAL	076649-001	Sep 5, 2007	AB	RX	No	No

Expired US Patents for carvedilol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995