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Azathioprine - Generic Drug Details

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

Azathioprine is the generic ingredient in four branded drugs marketed by Aaipharma Llc, Amneal Pharms Llc, Mylan, Zydus Pharms Usa, Sebela Ireland Ltd, West-ward Pharms Int, and Casper Pharma Llc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for azathioprine. Fifteen suppliers are listed for this compound.

Summary for azathioprine

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	7
Drug Master File Entries:	16
Suppliers / Packagers:	15
Bulk Api Vendors:	95
Clinical Trials:	248
Patent Applications:	7,365
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for azathioprine
Drug Sales Revenues:	Drug sales revenues for azathioprine
DailyMed Link:	azathioprine at DailyMed

Pharmacology for azathioprine

Drug Class	Purine Antimetabolite
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for azathioprine

Antimetabolites

Antimetabolites, Antineoplastic

Antirheumatic Agents

Immunosuppressive Agents

Synonyms for azathioprine

[Methyl(nitroimidazolyl)mercaptopurine]

055A974

1767-EP0930075A1

1767-EP2272822A1

1767-EP2272825A2

1767-EP2272827A1

1767-EP2272832A1

1767-EP2275420A1

1767-EP2277865A1

1767-EP2277876A1

1767-EP2281815A1

1767-EP2292227A2

1767-EP2292614A1

1767-EP2295409A1

1767-EP2295412A1

1767-EP2295413A1

1767-EP2295426A1

1767-EP2295427A1

1767-EP2298743A1

1767-EP2301933A1

1767-EP2311827A1

1767-EP2311837A1

1767-EP2314590A1

1767-EP2316834A1

1767-EP2371811A2

1H-Purine, 6-((1-methyl-4-nitro-1H-imidazol-5-yl)thio)-

1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-

446-86-6

446A866

55774-33-9 (hydrochloride salt)

6-((1-Methyl-4-nitro-1H-imidazol-5-yl)thio)-1H-purine

6-((1-methyl-4-nitro-1H-imidazol-5-yl)thio)-7H-purine

6-((1-Methyl-4-nitro-1H-imidazol-5-yl)thio)-9H-purine

6-((1-Methyl-4-nitroimidazol-5-yl)thio)purine

6-({4-nitro-1-methyl-1H-imidazol-5-yl}sulfanyl)-7H-purine

6-(1-methyl-4-nitro-1H-imidazol-5-ylthio)-9H-purine

6-(1-Methyl-4-nitro-5-imidazolythio)-9H-pur-ine

6-(1-Methyl-4-nitroimidazol-5-yl)thiopurine

6-(1-Methyl-4-nitroimidazol-5-ylthio)purin

6-(1-Methyl-4-nitroimidazol-5-ylthio)purin [Czech]

6-(1-Methyl-4-nitroimidazol-5-ylthio)purine

6-(1-Methyl-4-nitromidazol-5-ylthio)purine

6-(1-Methyl-p-nitro-5-imidazolyl)-thiopurine

6-(1-Methyl-p-nitro-5-imidazolyl)thiopurine

6-(1'-Methyl-4'-nitro-5'-imidazolyl)-mercaptopurine

6-(1'-Methyl-4'-nitro-5'-imidazolyl)mercaptopurine

6-(3-methyl-5-nitro-imidazol-4-yl)sulfanyl-7H-purine

6-(3-methyl-5-nitro-imidazol-4-yl)sulfanyl-9H-purine

6-(3-methyl-5-nitroimidazol-4-yl)sulfanyl-7H-purine

6-(Methyl-p-nitro-5-imidazolyl)-thiopurine

6-(Methyl-p-nitro-5-imidazolyl)thiopurine

6-[(1-Methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-1H-purine #

6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purine

6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-9H-purine

6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-Purine

6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-7H-purine

6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-9H-purine

6-[(1-Methyl-4-nitroimidazol-5-yl)- thio] purine

6-[(1-Methyl-4-nitroimidazol-5-yl)-thio] purine

6-[(1-Methyl-4-nitroimidazol-5-yl)thio]purine

6-1'-Methyl,4'-nitro,5'-imidazolyl mercaptopurine

6-1'-Methyl,5'-imidazolyl mercaptopurine

9H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-

A 4638

AB0014998

AB00443544

AB00443544_12

AB00443544_13

AB00443544-03

AB00443544-11

AB2000247

AC-4230

AC1L1DAL

AC1Q3Z1F

ACT02232

AG-670/36150031

AI3-50290

AJ-49795

AK-98682

AKOS005609209

AKOS022184498

AKOS028108935

AN-12213

API0001569

Azamun

Azamun [Czech]

Azamune

Azanin

azanine

Azasan

Azasan (TN)

Azasan, Imuran and others

Azasan;Imuran;Azamun;BW-57-322;NSC-39084

Azathioprin

Azathioprine (Azasan, Imuran)

Azathioprine (JP17/USP/INN)

Azathioprine [USAN:INN:BAN:JAN]

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

Azathioprine, >=98%

Azathioprine, European Pharmacopoeia (EP) Reference Standard

Azathioprine, meets USP testing specifications

Azathioprine, Pharmaceutical Secondary Standard; Certified Reference Material

Azathioprine, United States Pharmacopeia (USP) Reference Standard

Azathioprine(Azasan, Imuran)

Azathioprinum [INN-Latin]

Azathiopurine

Azathiopurine,(S)

azatiopr in

Azatioprin

Azatioprina

Azatioprina [INN-Spanish]

Azoran

Azothioprin

Azothioprine

B. W. 57-322

BCP09492

BDBM50373919

BG0097

BPBio1_000054

BRD-K32821942-001-05-6

BRD-K32821942-001-10-6

BRD-K60324116-001-01-5

BSPBio_000048

BSPBio_001876

BW 57-322

BW 57322

BW-57-322

C-17433

C06837

C9H7N7O2S

CAS-446-86-6

CBDivE_013132

CC-24218

CCG-16168

CCG-220094

CCG-39877

CCRIS 62

Ccucol

CHEBI:2948

CHEMBL1542

ChemDiv1_002659

cMAP_000046

CPD000427366

CS-2241

Cytostatics

D00238

DB00993

DivK1c_000586

DSSTox_CID_119

DSSTox_GSID_20119

DSSTox_RID_75381

DTXSID4020119

EINECS 207-175-4

EU-0100027

FT-0083532

FT-0602904

GP1145

GTPL7120

HMS1568C10

HMS1920E17

HMS2091K19

HMS2095C10

HMS2802J03

HMS3259P03

HMS3260E15

HMS3655M04

HMS3712C10

HMS501N08

HMS594I19

HSDB 7084

HY-B0256

IDI1_000586

Immuran

Imuran

Imuran (TN)

Imurek

Imurel

KBio1_000586

KBio2_000464

KBio2_002427

KBio2_003032

KBio2_004995

KBio2_005600

KBio2_007563

KBio3_001376

KBio3_002906

KBioGR_000646

KBioGR_002427

KBioSS_000464

KBioSS_002433

KS-00000XLZ

KS-1146

L996

LMEKQMALGUDUQG-UHFFFAOYSA-N

Lopac-A-4638

Lopac0_000027

LP00027

LS-123

MCULE-8637589610

Methylnitroimidazolylmercaptopurine

MFCD00069203

MLS001049307

MolPort-000-745-914

MolPort-000-764-262

MRK240IY2L

Muran

NC00614

NCGC00015060-01

NCGC00015060-02

NCGC00015060-03

NCGC00015060-04

NCGC00015060-05

NCGC00015060-06

NCGC00015060-07

NCGC00015060-08

NCGC00015060-09

NCGC00015060-10

NCGC00015060-11

NCGC00015060-12

NCGC00015060-13

NCGC00015060-14

NCGC00015060-15

NCGC00015060-16

NCGC00015060-18

NCGC00015060-19

NCGC00090836-01

NCGC00090836-02

NCGC00090836-03

NCGC00090836-04

NCGC00090836-05

NCGC00090836-06

NCGC00094593-01

NCGC00094593-02

NCGC00094593-03

NCGC00260712-01

NCI-C03474

NINDS_000586

NSC 39084

NSC-39084

NSC-755900

NSC39084

NSC755900

Oprea1_375441

Oprea1_533384

Oprea1_633462

Pharmakon1600-01500133

Prestwick_41

Prestwick0_000094

Prestwick1_000094

Prestwick2_000094

Prestwick3_000094

PubChem9256

Purine, 6-((1-methyl-4-nitroimidazol-5-yl)thio)-

Purine, 6-(1-methyl-4-nitro-5-imidazolylthio)-

Purine, 6-[(1-methyl-4-nitroimidazol-5-yl)thio]-

s1721

SAM002589938

SBI-0050016.P003

SC-04582

SCHEMBL4278

SDCCGMLS-0065415.P001

SMR000427366

SPBio_000255

SPBio_001987

Spectrum_000064

SPECTRUM1500133

Spectrum2_000068

Spectrum3_000308

Spectrum4_000243

Spectrum5_000848

SR-01000075537

SR-01000075537-1

SR-01000075537-4

SR-01000762955

SR-01000762955-2

ST24045004

STK831906

SW198560-2

Thiopurine 6-(1-methyl-4-nitroimidazol-5-yl)

Tox21_110074

Tox21_110074_1

Tox21_400024

Tox21_500027

UNII-MRK240IY2L

WLN: T56 BM DN FN HNJ IS- ET5N CNJ A1 DNW

Z57063156

ZINC4258316

US Patents and Regulatory Information for azathioprine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms Usa	AZATHIOPRINE	azathioprine	TABLET;ORAL	077621-004	Sep 5, 2008	AB	RX	No	No
Zydus Pharms Usa	AZATHIOPRINE	azathioprine	TABLET;ORAL	077621-003	Sep 5, 2008	AB	RX	No	No
Zydus Pharms Usa	AZATHIOPRINE	azathioprine	TABLET;ORAL	077621-001	Mar 15, 2007	AB	RX	No	No
Sebela Ireland Ltd	IMURAN	azathioprine	TABLET;ORAL	016324-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Aaipharma Llc	AZASAN	azathioprine	TABLET;ORAL	075252-001	Jun 7, 1999	AB	RX	No	No
Sebela Ireland Ltd	IMURAN	azathioprine	TABLET;ORAL	016324-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Casper Pharma Llc	IMURAN	azathioprine sodium	INJECTABLE;INJECTION	017391-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No