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Teva
Cerilliant
Covington
Fuji
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Mallinckrodt
Cantor Fitzgerald
Colorcon
Argus Health

Generated: October 21, 2018

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INLYTA Drug Profile

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When do Inlyta patents expire, and when can generic versions of Inlyta launch?

Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

Drug patent expirations by year for INLYTA
Generic Entry Opportunity Date for INLYTA
Generic Entry Date for INLYTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for INLYTA
Synonyms for INLYTA
(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
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 (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 INLYTA

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 ➤ Sign Up
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 202324-001 Jan 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up 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 202324-002 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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Paragraph IV (Patent) Challenges for INLYTA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 1 mg and 5 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for INLYTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00010 Denmark ➤ Sign Up
2013003 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
90007-1 Sweden ➤ Sign Up PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
00576 Netherlands ➤ Sign Up PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348/01 Switzerland ➤ Sign Up FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
2013003,C1218348 Lithuania ➤ Sign Up PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Cerilliant
Covington
Fuji
Merck
Mallinckrodt
Cantor Fitzgerald
Colorcon
Argus Health

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