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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.
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
DrugPatentWatch® Estimated Generic Entry Opportunity Date for trikafta (copackaged)
*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.
|Country||Patent Number||Estimated Expiration|
|World Intellectual Property Organization (WIPO)||2006002421||Get Started for $10|
|China||109081804||Get Started for $10|
|New Zealand||587547||Get Started for $10|
|Poland||2674428||Get Started for $10|
|>Country||>Patent Number||>Estimated Expiration|
|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|