You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Colorcon
AstraZeneca
McKesson
Johnson and Johnson

Last Updated: May 13, 2021

DrugPatentWatch Database Preview

IVACAFTOR; IVACAFTOR, TEZACAFTOR - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of freedom to operate?

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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; ivacaftor, tezacaftor has three hundred and forty-three patent family members in thirty-seven countries.

There are three drug master file entries for ivacaftor; ivacaftor, tezacaftor. One supplier is listed for this compound.

Summary for IVACAFTOR; IVACAFTOR, TEZACAFTOR
International Patents:343
US Patents:21
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Clinical Trials: 29
DailyMed Link:IVACAFTOR; IVACAFTOR, TEZACAFTOR at DailyMed
Recent Clinical Trials for IVACAFTOR; IVACAFTOR, TEZACAFTOR

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

SponsorPhase
Children's Hospital Medical Center, CincinnatiN/A
Cystic Fibrosis TrustPhase 2
Nottingham University Hospitals NHS TrustPhase 2

See all IVACAFTOR; IVACAFTOR, TEZACAFTOR clinical trials

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, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
>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 IVACAFTOR; IVACAFTOR, TEZACAFTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 PA2015028 Lithuania   Get Started for $10 PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816 C20150028 00162 Estonia   Get Started for $10 PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
1773816 122015000050 Germany   Get Started for $10 PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
1773816 C300748 Netherlands   Get Started for $10 PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 300748 Netherlands   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
AstraZeneca
Dow
Merck
McKinsey

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.