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Axitinib - Generic Drug Details
What are the generic drug sources for axitinib and what is the scope of axitinib freedom to operate?
Axitinib
is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for axitinib. Two suppliers are listed for this compound.
Summary for axitinib
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 89 |
| Patent Applications: | 167 |
| DailyMed Link: | axitinib at DailyMed |
Pharmacology for axitinib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Synonyms for axitinib
| (E)-N-Methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide |
| (E)-N-methyl-2-(3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-ylthio)benzamide |
| 319460-85-0 |
| 460A850 |
| 4ag8 |
| 4agc |
| 4CA-0215 |
| 790713-39-2 |
| AB0008632 |
| AB01274739_02 |
| AB01274739-01 |
| ABP000115 |
| AC-1539 |
| AC1O51X3 |
| AG 013736 |
| AG-013736 |
| AG-013736, Axitinib |
| AG-013736;Axitinib |
| AG-13736 |
| AG013736 |
| AG13736 |
| AJ-45709 |
| AK106979 |
| AKOS015902898 |
| AM20090673 |
| AN-501 |
| AOB87786 |
| Axitinib (AG 013736) |
| Axitinib (JAN/USAN) |
| Axitinib (VEGFR inhibitor) |
| Axitinib [USAN:INN:JAN] |
| Axitinib, >=98% (HPLC) |
| Axitinib,AG-013736 |
| Axitinib/AG013736 |
| Axitinib|319460-85-0|AG 013736|AG013736 |
| axitinibum |
| BC659937 |
| BCP9000345 |
| BCPP000372 |
| BDBM25117 |
| Benzamide, N-methyl-2-((3-((1E)-2-(2-pyridinyl)ethenyl)-1H-indazo)-6-yl)thio)- |
| BRD-K29905972-001-01-4 |
| C22H18N4OS |
| C9LVQ0YUXG |
| CAS-319460-85-0 |
| cc-356 |
| CHEBI:66910 |
| CHEBI:94568 |
| CHEMBL1289926 |
| CJ-10777 |
| CS-0116 |
| D01ZRI |
| D03218 |
| DB06626 |
| DSSTox_CID_28975 |
| DSSTox_GSID_49049 |
| DSSTox_RID_83240 |
| DTXSID3049049 |
| EX-A337 |
| GTPL5659 |
| HE066076 |
| HE334772 |
| HY-10065 |
| I14-1971 |
| Inlyta |
| Inlyta (TN) |
| J-502064 |
| KB-02558 |
| KB-74537 |
| KS-1448 |
| MFCD09837898 |
| MLS006010164 |
| MolPort-006-392-413 |
| N-Methyl-[[3[(1E)-2-(2-pyridinyl)ethenyl]-1H-indazol-6-yl]thio]-benzamide |
| N-methyl-2-((3-((1E)-2-(pyridin-2-yl)ethenyl)-1H-indazol-6-yl)sulfanyl)benzamide |
| N-methyl-2-({3-[(E)-2-(pyridin-2-yl)ethenyl]-1H-indazol-6-yl}sulfanyl)benzamide |
| N-methyl-2-({3-[(E)-2-(pyridin-2-yl)vinyl]-1H-indazol-6-yl}sulfanyl)benzamide |
| N-methyl-2-[[3-[(E)-2-(2-pyridyl)vinyl]-1H-indazol-6-yl]sulfanyl]benzamide |
| N-methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide |
| NCGC00241108-01 |
| NCGC00241108-04 |
| NSC-757441 |
| NSC757441 |
| Q-200662 |
| Q-3279 |
| QCR-109 |
| RL03128 |
| S1005 |
| SC-22491 |
| SCHEMBL172918 |
| SMR002530046 |
| SR-01000941566 |
| SR-01000941566-1 |
| ST51054130 |
| SYN1014 |
| Tox21_113597 |
| Tox21_113597_1 |
| TR-013491 |
| UNII-C9LVQ0YUXG |
| ZINC3816287 |
US Patents and Regulatory Information for axitinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
International Patents for axitinib
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Africa | 200906990 | ➤ Try a Free Trial |
| China | 103626739 | ➤ Try a Free Trial |
| Morocco | 26803 | ➤ Try a Free Trial |
| Japan | 2003503481 | ➤ Try a Free Trial |
| Uruguay | 26231 | ➤ Try a Free Trial |
| Bulgaria | 66070 | ➤ Try a Free Trial |
| Costa Rica | 6517 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for axitinib
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2013003,C1218348 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903 |
| 1218348/01 | Switzerland | ➤ Try a Free Trial | FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US |
| 00576 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903 |
| 8 | Finland | ➤ Try a Free Trial | |
| 154 | Luxembourg | ➤ Try a Free Trial | PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE |
| 2013 00010 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903 |
| 90007-1 | Sweden | ➤ Try a Free Trial | PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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