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Azathioprine - Generic Drug Details
What are the generic sources for azathioprine and what is the scope of 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. Eleven 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: | 11 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 252 |
| Patent Applications: | 7,342 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for azathioprine |
| Drug Sales Revenues: | Drug sales revenues for azathioprine |
| DailyMed Link: | azathioprine at DailyMed |
Recent Clinical Trials for azathioprine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cairo University | Phase 1 |
| French Vasculitis Study Group | Phase 3 |
| Hull and East Yorkshire Hospitals NHS Trust | Phase 2 |
Pharmacology for azathioprine
| Drug Class | Purine Antimetabolite |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for azathioprine
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 | 077621-003 | Sep 5, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sebela Ireland Ltd | IMURAN | azathioprine | TABLET;ORAL | 016324-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Aaipharma Llc | AZASAN | azathioprine | TABLET;ORAL | 075252-003 | Feb 3, 2003 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Casper Pharma Llc | IMURAN | azathioprine sodium | INJECTABLE;INJECTION | 017391-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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ISSN: 2162-2639
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Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.