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Generated: December 10, 2018

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CAPRELSA Drug Profile

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Which patents cover Caprelsa, and when can generic versions of Caprelsa launch?

Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-seven patent family members in forty-two countries.

The generic ingredient in CAPRELSA is vandetanib. Two suppliers are listed for this compound. Additional details are available on the vandetanib profile page.

Drug patent expirations by year for CAPRELSA
Generic Entry Opportunity Date for CAPRELSA
Generic Entry Date for CAPRELSA*:
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.

Synonyms for CAPRELSA
(4-Bromo-2-fluoro-phenyl)-[6-methoxy-7-(1-methyl-piperidin-4-ylmethoxy)-quinazolin-4-yl]-amine
2ivu
338992-00-0
4-(4-Bromo-2-fluoroanilino)-6-methoxy- 7-[(1-methylpiperidin-4-yl)methoxy]quinazoline
4-(4-Bromo-2-fluoroanilino)-6-methoxy-7-(1-methylpiperidin-4-yl)methoxyquinazoline
4-(4-bromo-2-fluoroanilino)-6-methoxy-7-(1-methylpiperidin-4-ylmethoxy)quinazoline
4-(4-Bromo-2-fluoroanilino)-6-methoxy-7-[(1-methylpiperidin-4-yl)methoxy]quinazoline
4-[(4-Bromo-2-fluorophenyl)amino]-6-methoxy-7-[(1-methyl-4-piperidyl)methoxy]quinazoline
4-BROMO-2-FLUORO-N-[(4E)-6-METHOXY-7-[(1-METHYLPIPERIDIN-4-YL)METHOXY]QUINAZOLIN-4(1H)-YLIDENE]ANILINE
4-Quninazolinamine, N-(4-bromo-2-fluorophenyl)-6-methoxy-7-((1-methyl-4-piperidinyl)methoxy)-
443913-73-3
68541-EP2298768A1
68541-EP2308855A1
913V733
A25648
AB0008635
AB01273969_04
AB01273969-01
AB01273969-02
AB1008463
ABP000873
AC-5251
AC1MIWRU
AJ-45811
AK106976
AKOS015902350
AN-3469
ANW-61824
AOB87780
AS-11067
AZD-6474
BC224441
BCPP000023
BDBM21
C22H24BrFN4O2
Caprelsa (TN)
CAS-443913-73-3
CH 331
CH-331
CHEBI:49960
CHEMBL24828
cid_3081361
CS-0130
CTK8B9016
D06407
D0G6QF
DB05294
DMPC Cyclic Urea 1
DSSTox_CID_26681
DSSTox_GSID_46681
DSSTox_RID_81816
DTXSID1046681
EN002713
EX-A422
F9995-0087
FT-0656736
GNF-PF-2188
GTPL5717
HE069787
HE343618
HMS3244K03
HMS3244K04
HMS3244L03
HMS3654E11
HSDB 8198
HY-10260
I14-1942
KB-34269
Kinome_3316
LS-184394
MCULE-4705827953
MFCD07772346
MLS006011672
MolPort-005-942-399
N-(4-bromo-2-fluoro-phenyl)-6-methoxy-7-[(1-methyl-4-piperidyl)methoxy]quinazolin-4-amine
N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-((1-methyl-4-piperidinyl)methoxy)-4-quinazolinamine
N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-((1-methylpiperidin-4-yl)methoxy)quinazolin-4-amine
N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-[(1-methyl-4-piperidinyl)methoxy]-4-quinazolinamine
N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl)methoxy]quinazolin-4-amine
NCGC00167513-01
NCGC00167513-02
NCGC00167513-03
NCGC00167513-04
NSC-744325
NSC-760766
NSC744325
NSC760766
PubChem22460
QCR-37
Quinazolin-4-amine, N-(4-bromo-2-fluorophenyl)-6-mthoxy-7-[(1-methyl-4-piperidinyl)methoxy]-
RS0036
RT-016214
s1046
SC-23330
SCHEMBL9044
SMR002530472
SR-00000000462
SR-00000000462-2
ST2407381
SYN1090
Tox21_112511
Tox21_112511_1
UHTHHESEBZOYNR-UHFFFAOYSA-N
UNII-YO460OQ37K
V-9402
Vandetanib
Vandetanib (JAN/INN)
Vandetanib (JAN/USAN/INN)
Vandetanib (Pan-TK inhibitor)
vandetanib (zd6474)
Vandetanib [INN]
Vandetanib [USAN:INN:BAN:JAN]
Vandetanib, Zactima, ZD6474
Vandetanib;7-((4-aminocyclohexyl)methoxy)-N-(4-bromo-2-fluorophenyl)-6-methoxyquinazolin-4-amine
Vandetanib(Zactima),ZD6474/
Vandetinib
W-5356
YO460OQ37K
Zactima
Zactima, ZD6474
ZD 6474
ZD-64
ZD-6474
ZD6474
ZINC53683345

US Patents and Regulatory Information for CAPRELSA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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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Supplementary Protection Certificates for CAPRELSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0048 France ➤ Sign Up PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
2012000057 Germany ➤ Sign Up PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
057 Luxembourg ➤ Sign Up 92057, EXPIRES: 20251101
2012 00032 Denmark ➤ Sign Up
12/029 Ireland ➤ Sign Up PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
0543 Netherlands ➤ Sign Up PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
2012000001 Germany ➤ Sign Up PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Dow
Cantor Fitzgerald
McKinsey
QuintilesIMS
Chinese Patent Office
Queensland Health
Medtronic
Merck

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