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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
UBS
Johnson and Johnson
Boehringer Ingelheim
Healthtrust
Queensland Health
Fish and Richardson
Harvard Business School
Accenture

Generated: May 25, 2018

DrugPatentWatch Database Preview

Ivacaftor - Generic Drug Details

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

Ivacaftor
is the generic ingredient in three branded drugs marketed by Vertex Pharms Inc and Vertex Pharms, and is included in four NDAs. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has one hundred and thirty-six patent family members in twenty-five countries.

There are three drug master file entries for ivacaftor. One supplier is listed for this compound.
Summary for ivacaftor
International Patents:136
US Patents:25
Tradenames:3
Applicants:2
NDAs:4
Drug Master File Entries: 3
Suppliers / Packagers: 1
Bulk Api Vendors: 64
Clinical Trials: 71
Patent Applications: 279
DailyMed Link:ivacaftor at DailyMed
Synonyms for ivacaftor
1134822-00-6
1174930-71-2
1413431-05-6
1Y740ILL1Z
3-Quinolinecarboxamide, N-(2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl)-1,4-dihydro-4-oxo-
3-Quinolinecarboxamide, N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-
4CA-0661
873054-44-5
A25626
AB0008116
AB01565806_02
AB2000007
ABP000259
AC-28324
AK170457
AKOS015994762
AKOS032950001
AN-16981
AOB31714
BC660099
BCP9000799
BCPP000199
BDBM50032693
CHEBI:66901
CHEMBL2010601
CS-0497
D09916
D0W7WC
DB08820
DTXSID00236281
EX-7211
EX-A441
FT-0696681
GTPL4342
HE066376
HE399755
HMS3654E10
HY-13017
Ivacaftor (USAN/INN)
Ivacaftor (VX-770)
Ivacaftor [USAN:INN]
Ivacaftor-d18
ivacaftorum
Kalydeco
Kalydeco (TN)
Kalydeco|||N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-3-quinolinecarboxamide
KB-81476
KS-0000063W
LE-0002
MFCD17171361
MLS006011119
MolPort-009-194-229
N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
N-(2,4-ditert-butyl-5-hydroxy-phenyl)-4-oxo-1H-quinoline-3-carboxamide
N-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide
N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
N-[2,4-Bis(tert-butyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-3-quinolinecarboxamide
NCGC00242480-01
PURKAOJPTOLRMP-UHFFFAOYSA-N
QCR-155
QUI135
s1144
SC-95534
SCHEMBL351373
SMR004702900
Tube715
UNII-1Y740ILL1Z
VX 770
VX-770
VX-770 - Ivacaftor
VX-770, Ivacaftor, Kalydeco
VX-770/VX770
VX770
VX770, VX 770, Ivacaftor, 873054-44-5
W-5681
X7565
ZINC52509463

US Patents and Regulatory Information for ivacaftor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-001 Jan 31, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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

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Non-Orange Book US Patents for ivacaftor

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
9,090,619 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
8,614,327 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
2,014,187,770 ➤ Try a Free Trial
8,829,204 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ivacaftor

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725
90036-8 Sweden ➤ Try a Free Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725
2015028 Lithuania ➤ Try a Free Trial PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
00748 Netherlands ➤ Try a Free Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Express Scripts
AstraZeneca
Dow
Merck
Accenture
Mallinckrodt
Covington

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.