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TRIKAFTA (COPACKAGED) Drug Profile
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When do Trikafta (copackaged) patents expire, and when can generic versions of Trikafta (copackaged) launch?
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 fifty-three 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.
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 December 8, 2037. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TRIKAFTA (COPACKAGED)
| International Patents: | 353 |
| US Patents: | 21 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| DailyMed Link: | TRIKAFTA (COPACKAGED) at DailyMed |
-patent-expirations.png "TRIKAFTA (COPACKAGED) drug patent expirations")
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)
International Patents for TRIKAFTA (COPACKAGED)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Montenegro | 03019 | Start Trial |
| Serbia | 60205 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011019413 | Start Trial |
| Lithuania | 2489659 | Start Trial |
| Israel | 221827 | Start Trial |
| Russian Federation | 2552353 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1773816 | CR 2015 00038 | Denmark | Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725 |
| 1773816 | 2015/036 | Ireland | Start Trial | PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723 |
| 1773816 | 1590036-8 | Sweden | Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725 |
| 1773816 | PA2015028 | Lithuania | Start Trial | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
| 1773816 | C01773816/01 | Switzerland | Start Trial | PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014 |
| 1773816 | 300748 | Netherlands | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
