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Last Updated: May 15, 2021

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trikafta (copackaged) Drug Profile

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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 twenty-one patents protecting this drug.

This drug has three hundred and sixty-four patent family members in forty 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.

DrugPatentWatch® 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 December 8, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for trikafta (copackaged)
International Patents:364
US Patents:21
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:trikafta (copackaged) at DailyMed
Drug patent expirations by year for trikafta (copackaged)
DrugPatentWatch® Estimated 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   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 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 trikafta (copackaged)

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 35/2015 Austria   Get Started for $10 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
1773816 PA2015028,C1773816 Lithuania   Get Started for $10 PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
1773816 CA 2015 00038 Denmark   Get Started for $10 PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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