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Captopril - Generic Drug Details

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

Captopril is the generic ingredient in seven branded drugs marketed by Par Pharm, Apotex, Apothecon, Boscogen, Dava Pharms Inc, Egis Pharms, G And W Labs Inc, Hikma Intl Pharms, Mylan Pharms Inc, Oxford Pharms, Prinston Inc, Purepac Pharm, Sandoz, Teva, Watson Labs, Wockhardt Ltd, Yaopharma Co Ltd, Ivax Sub Teva Pharms, Mylan, and Vintage Pharms Llc, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for captopril. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for captopril

US Patents:	0
Tradenames:	7
Applicants:	20
NDAs:	30
Drug Master File Entries:	15
Suppliers / Packagers:	25
Bulk Api Vendors:	92
Clinical Trials:	34
Patent Applications:	7,127
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for captopril
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for captopril
DailyMed Link:	captopril at DailyMed

Pharmacology for captopril

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for captopril

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Synonyms for captopril

(-)-Captopril

((S)-3-mercapto-2-methylpropanoyl)-L-proline

(2S)-1-((2S)-2-methyl-3-sulfanylpropanoyl)pyrrolidine-2-carboxylic acid

(2S)-1-(3-Mercapto-2-methylpropionyl)-L-proline

(2S)-1-[(2S)-2-methyl-3-sulfanylpropanoyl]pyrrolidine-2-carboxylic acid

(S)-1-((S)-3-mercapto-2-methylpropanoyl)pyrrolidine-2-carboxylic acid

(S)-1-(3-Mercapto-2-methyl-1-oxo-propyl)-L-proline

(S)-1-(3-Mercapto-2-methyl-1-oxopropyl)-L-proline

[2S]-1-[3-Mercapto-2-methylpropionyl]-L-proline

1-((2S)-2-Methyl-3-sulfanylpropanoyl)-L-proline #

1-((2S)-3-Mercapto-2-methylpropionyl)-L-proline

1-(3-Mercapto-2-methyl-1-oxopropyl)-L-proline

1-(D-3-Mercapto-2-methyl-1-oxopropyl)-L-proline (S,S)

1-[(2S)-2-methyl-3-sulfanylpropanoyl]-L-proline

1-[(2S)-3-Mercapto-2-methyl-1-oxopropyl]-L-proline

1-[(2S)-3-Mercapto-2-methylpropionyl]- L-proline

1-[(2s)-3-mercapto-2-methylpropionyl]-l-proline

1-[(S)-3-mercapto-2-methyl-1-oxopropyl]-L-proline

1-Pyrrolidinecarboxylic acid, 1-(D-3-mercapto-2-methyl-1-propionyl)-, L-(S,S)-

138452-88-7

1j37

225661-74-5

3-Mercapto-2-methylpropionyl-proline

54254-EP2269989A1

54254-EP2270011A1

54254-EP2272841A1

54254-EP2277879A1

54254-EP2287165A2

54254-EP2287166A2

54254-EP2292620A2

54254-EP2295406A1

54254-EP2298742A1

54254-EP2298772A1

54254-EP2298776A1

54254-EP2298779A1

54254-EP2301923A1

54254-EP2301931A1

54254-EP2301936A1

54254-EP2305219A1

54254-EP2305648A1

54254-EP2308562A2

54254-EP2308839A1

571C862

62571-86-2

70903-77-4

9G64RSX1XD

AB00052156_17

AB00052156_18

AB00052156-16

AB0007072

AB04252

AB2000455

AC-12047

AC1L2B4L

AC1Q29GZ

AC1Q5R48

Acediur

Aceplus

Acepress

Acepril

AKOS005622581

Alopresin

Apopril

Apopril (TN)

Asisten

BBL033600

BC203925

BCP9000485

BDBM21642

BIM-0050290.0001

BPBio1_000063

BRD-K54529596-001-04-0

BRD-K54529596-001-15-6

BSPBio_000057

BSPBio_002976

C 4042

C06867

C9H15NO3S

Capoten

Capoten (TN)

Capozide (Salt/Mix)

Captolane

Captopril (Capoten)

Captopril (JP17/USP/INN)

Captopril [USAN:INN:BAN:JAN]

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

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

Captopril, >=98% (HPLC), powder

Captopril, 98%

Captopril, British Pharmacopoeia (BP) Reference Standard

Captopril, European Pharmacopoeia (EP) Reference Standard

Captopril, meets USP testing specifications

Captopril, Pharmaceutical Secondary Standard; Certified Reference Material

Captopril, United States Pharmacopeia (USP) Reference Standard

Captopril,(S)

Captoprilum

Captoprilum [INN-Latin]

Captopryl

Captoril

Captril

CCG-39104

Cesplon

CHEBI:3380

CHEMBL1560

component of Acezide (Salt/Mix)

component of Captea (Salt/Mix)

component of Ecazide (Salt/Mix)

CPD000059061

CS-2425

D-2-Methyl-3-mercaptopropanoyl-L-proline

D-3-Mercapto-2-methylpropanoyl-L-proline

D-3-Mercapto-2-methylpropionylproline

D00251

DB01197

Dilabar

DivK1c_000208

DSSTox_CID_17197

DSSTox_GSID_37197

DSSTox_RID_79306

DTXSID1037197

EI-213

EINECS 263-607-1

Epitope ID:114065

EU-0100302

FAKRSMQSSFJEIM-RQJHMYQMSA-N

Farcopril

FT-0082749

Garranil

Garranil (discontinued)

GTPL5158

Hipertil

HMS1921C12

HMS2089P19

HMS2092I12

HMS2095C19

HMS2233I04

HMS3259G10

HMS3260N06

HMS3712C19

HMS500K10

HSDB 6527

HY-B0368

Hypertil

Hypopress

IDI1_000208

Isopresol

J10167

KBio1_000208

KBio2_001168

KBio2_003736

KBio2_006304

KBio3_002196

KBioGR_001321

KBioSS_001168

KM0635

KS-00000XHT

KS-5025

L-?Proline, 1-?[(2S)?-?3-?mercapto-?2-?methyl-?1-?oxopropyl]?-

L-Captopril

L-Proline, 1-((2S)-3-mercapto-2-methyl-1-oxopropyl)-

L-Proline, 1-(3-mercapto-2-methyl-1-oxopropyl)-, (S)-

L-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]-

Lopac-C-4042

Lopac0_000302

Lopirin

Lopirin [Switzerland]

Lopril

LP00302

LS-137465

MCULE-1716939647

MFCD00168073

MLS000069484

MLS001076488

MolPort-001-794-639

N-[(S)-3-Mercapto-2-methylpropionyl]-L-proline

NC00554

NCGC00015235-01

NCGC00015235-02

NCGC00023654-03

NCGC00023654-04

NCGC00023654-05

NCGC00023654-06

NCGC00023654-07

NCGC00023654-08

NCGC00023654-09

NCGC00023654-10

NCGC00023654-11

NCGC00023654-13

NCGC00260987-01

NINDS_000208

Novocaptopril

NSC-757419

NSC757419

Opera_ID_1041

Pharmakon1600-01500682

Prestwick_103

Prestwick3_000019

s2051

SA 333

SAM002564201

SBB017523

SBI-0050290.P004

SCHEMBL4

SMP1_000056

SMR000059061

SPBio_001022

Spectrum_000688

SPECTRUM1500682

Spectrum2_001211

Spectrum3_001388

Spectrum4_000811

Spectrum5_001587

SQ 14,225

SQ 14225

SQ-14,225

SQ-14,534

SQ-14225

SQ-14534

SQ14534

SR-01000000039

SR-01000000039-2

SR-01000075603

SR-01000075603-1

SR-01000075603-3

ST079562

STK802012

Tenosbon

Tensiomin

Tensobon

Tensoprel

Tox21_110890

Tox21_110890_1

Tox21_500302

UNII-9G64RSX1XD

UPCMLD-DP003

UPCMLD-DP003:001

X8Z

Z2786051697

Zapto

ZINC57001

Generic filers with tentative approvals for CAPTOPRIL

Applicant	Application No.	Strength	Dosage Form
		50MG;25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for captopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	CAPTOPRIL	captopril	TABLET;ORAL	074477-003	Feb 13, 1996	AB	RX	No	No
G And W Labs Inc	CAPTOPRIL	captopril	TABLET;ORAL	074462-002	Feb 13, 1996		DISCN	No	No
Par Pharm	CAPTOPRIL	captopril	TABLET;ORAL	074493-002	Feb 13, 1996		DISCN	No	No
Apothecon	CAPOZIDE 25/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-001	Oct 12, 1984		DISCN	Yes	No
Mylan Pharms Inc	CAPTOPRIL	captopril	TABLET;ORAL	074434-004	Feb 13, 1996	AB	RX	No	Yes
Dava Pharms Inc	CAPTOPRIL	captopril	TABLET;ORAL	074423-004	Feb 13, 1996		DISCN	No	No

Expired US Patents for captopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-002	Approved Prior to Jan 1, 1982
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-001	Approved Prior to Jan 1, 1982
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-001	Approved Prior to Jan 1, 1982
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-005	Jan 17, 1985
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-006	Sep 17, 1986