➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Dow
Express Scripts
Colorcon
AstraZeneca

Last Updated: May 27, 2020

DrugPatentWatch Database Preview

TRIKAFTA (COPACKAGED) Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Trikafta (copackaged), and what generic alternatives are available?

Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has two hundred and twenty-six patent family members in twenty-nine countries.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.

US ANDA Litigation and Generic Entry Outlook for Trikafta (copackaged)

Trikafta (copackaged) will be eligible for patent challenges on October 21, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Summary for TRIKAFTA (COPACKAGED)
International Patents:226
US Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: 1
DailyMed Link:TRIKAFTA (COPACKAGED) at DailyMed
Drug patent expirations by year for TRIKAFTA (COPACKAGED)
Generic Entry Opportunity Date for TRIKAFTA (COPACKAGED)
Generic Entry Date for TRIKAFTA (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for TRIKAFTA (COPACKAGED)

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 TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 TRIKAFTA (COPACKAGED)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 PA2015028,C1773816 Lithuania   Start Trial PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
1773816 C 2015 027 Romania   Start Trial PRODUCT NAME: IVACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAN-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1H-CHINOLIN-3-CARBOXAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001, EU/1/12/782/002; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782/001, EU/1/12/782/002; DATE OF FIRST AUTHORISATION IN EEA: 20120723
1773816 15C0045 France   Start Trial PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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:

Johnson and Johnson
McKesson
Dow
Express Scripts
Colorcon
AstraZeneca

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.