You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 22, 2024

Ivacaftor; ivacaftor, tezacaftor - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Ivacaftor; ivacaftor, tezacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; ivacaftor, tezacaftor has four hundred and sixteen patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for ivacaftor; ivacaftor, tezacaftor
International Patents:416
US Patents:24
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 44
DailyMed Link:ivacaftor; ivacaftor, tezacaftor at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ivacaftor; ivacaftor, tezacaftor
Generic Entry Date for ivacaftor; ivacaftor, tezacaftor*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, 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.

Recent Clinical Trials for ivacaftor; ivacaftor, tezacaftor

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

SponsorPhase
University of North Carolina, Chapel HillPhase 4
Chiesi USA, Inc.Phase 4
Emory UniversityPhase 4

See all ivacaftor; ivacaftor, tezacaftor clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ivacaftor; ivacaftor, tezacaftor

US Patents and Regulatory Information for ivacaftor; ivacaftor, tezacaftor

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 SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ivacaftor; ivacaftor, tezacaftor

Country Patent Number Title Estimated Expiration
Canada 2733908 COMPOSITION PHARMACEUTIQUE ET ADMINISTRATIONS DE CELLE-CI (PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS THEREOF) ⤷  Try a Trial
Serbia 56894 FARMACEUTSKA KOMPOZICIJA N-[2,4-BIS(1,1-DIMETILETIL)-5-HIDROKSIFENIL]-1,4-DIHIDRO-4-OKSOHINOLIN-3-KARBOKSAMIDA I NJENO ORDINIRANJE (PHARMACEUTICAL COMPOSITION OF N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4- OXOQUINOLINE-3-CARBOXAMIDE AND ADMINISTRATION THEREOF) ⤷  Try a Trial
Cyprus 1119945 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivacaftor; ivacaftor, tezacaftor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3170818 C202030042 Spain ⤷  Try a Trial PRODUCT NAME: UNA COMBINACION DE A) LUMACAFTOR Y B) IVACAFTOR; NATIONAL AUTHORISATION NUMBER: EU/1/15/1059; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1059; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1773816 300748 Netherlands ⤷  Try a Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 C01773816/01 Switzerland ⤷  Try a Trial PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.