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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Covington
Daiichi Sankyo
US Army
Citi
Chinese Patent Office
UBS
Johnson and Johnson
Fuji

Generated: July 21, 2018

DrugPatentWatch Database Preview

Axitinib - Generic Drug Details

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What are the generic sources for axitinib and what is the scope of axitinib patent protection?

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.

Axitinib has one hundred and nine patent family members in fifty-three countries.

There are four drug master file entries for axitinib. Two suppliers are listed for this compound.
Summary for axitinib
International Patents:109
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Suppliers / Packagers: 2
Bulk Api Vendors: 88
Clinical Trials: 89
Patent Applications: 160
DailyMed Link:axitinib at DailyMed
Pharmacology for axitinib
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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for axitinib

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,531,491 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use ➤ Sign Up
6,884,890 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use ➤ Sign Up
6,891,044 Indazole compounds and pharmaceutical compositions for Inhibiting protein kinases, and methods for their use ➤ Sign Up
7,141,587 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for axitinib

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013003 Lithuania ➤ Sign Up PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
2013000016 Germany ➤ Sign Up PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
2013003,C1218348 Lithuania ➤ Sign Up PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
C0010 France ➤ Sign Up PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
McKinsey
Cantor Fitzgerald
Teva
QuintilesIMS
Baxter
Deloitte
Dow

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.