Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Axitinib - Generic Drug Details

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What are the generic sources for axitinib and what is the scope of 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 eleven patent family members in fifty-four countries.

There are four drug master file entries for axitinib. Two suppliers are listed for this compound.

Recent Clinical Trials for axitinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
RenJi HospitalPhase 2
BioGene Pharmaceutical Ltd.Phase 1/Phase 2
Peking Union Medical College HospitalPhase 2

See all axitinib clinical trials

Recent Litigation for axitinib

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Apotex Inc.2018-05-25

See all axitinib litigation

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-13736
AG013736
AG13736
AJ-45709
AK106979
AKOS015902898
AM20090673
AN-501
AOB87786
Axitinib (JAN/USAN)
Axitinib [USAN:INN:JAN]
Axitinib, >=98% (HPLC)
Axitinib,AG-013736
Axitinib/AG013736
Axitinib|319460-85-0|AG 013736|AG013736
axitinibum
BC659937
BCP01371
BCP9000345
BCPP000372
BDBM25117
Benzamide, N-methyl-2-((3-((1E)-2-(2-pyridinyl)ethenyl)-1H-indazo)-6-yl)thio)-
Benzamide, N-methyl-2-[[3-[(1E)-2-(2-pyridinyl)ethenyl]-1H-indazol-6-yl]thio]-
BRD-K29905972-001-01-4
BRD-K29905972-001-02-2
C22H18N4OS
C9LVQ0YUXG
CAS-319460-85-0
cc-356
CHEBI:66910
CHEBI:94568
CHEMBL1289926
CJ-10777
CS-0116
D03218
DB06626
DSSTox_CID_28975
DSSTox_GSID_49049
DSSTox_RID_83240
DTXSID3049049
EX-A337
GTPL5659
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-pyridin-2-ylethenyl]-2H-indazol-6-yl}sulfanyl)benzamide
N-METHYL-2-(3-((E)-2-PYRIDIN-2-YL-VINYL)-1H-INDAZOL-6-YLSULFANYL)-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
NCGC00241108-06
NSC-757441
NSC757441
Q-200662
Q-3279
QCR-109
RL03128
S1005
SB20061
SC-22491
SCHEMBL172918
SMR002530046
SR-01000941566
SR-01000941566-1
SW219464-1
SYN1014
Tox21_113597
Tox21_113597_1
TR-013491
UNII-C9LVQ0YUXG
ZINC3816287
Paragraph IV (Patent) Challenges for AXITINIB
Tradename Dosage Ingredient NDA Submissiondate
INLYTA TABLET;ORAL axitinib 202324 2018-02-23

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   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   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

Supplementary Protection Certificates for axitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 C01218348/01 Switzerland   Start Trial FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348 438 Finland   Start Trial
1218348 CA 2013 00010 Denmark   Start Trial
1218348 C 2013 006 Romania   Start Trial PRODUCT NAME: AXITINIB,OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/777/001, RO EU/1/12/777/002, RO EU/1/12/777/003, RO EU/1/12/777/004, RO EU/1/12/777/005, RO EU/1/12/777/006; DATE OF NATIONAL AUTHORISATION: 20120903; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/777/001, EMEA EU/1/12/777/002, EMEA EU/1/12/777/003, EMEA EU/1/12/777/004, EMEA EU/1/12/777/005, EMEA EU/1/12/777/006; DATE OF FIRST AUTHORISATION IN EEA: 20120903
1218348 2013C/015 Belgium   Start Trial PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Dow
Moodys
Merck
McKesson
McKinsey

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