ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - Generic Drug Details
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What are the generic sources for elexacaftor, ivacaftor, tezacaftor; ivacaftor and what is the scope of patent protection?
Elexacaftor, ivacaftor, tezacaftor; ivacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elexacaftor, ivacaftor, tezacaftor; ivacaftor has five hundred and one patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
| International Patents: | 501 |
| US Patents: | 32 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 21 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
| DailyMed Link: | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
*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.
Recent Clinical Trials for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chiesi USA, Inc. | Phase 4 |
| University of North Carolina, Chapel Hill | Phase 4 |
| Emory University | Phase 4 |
See all ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patents and Regulatory Information for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
| 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;ORAL | 212273-001 | Oct 21, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660-001 | Apr 26, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | TABLET;ORAL | 212273-002 | Jun 8, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | TABLET;ORAL | 212273-001 | Oct 21, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 2464337 | ⤷ Sign Up | |
| New Zealand | 718018 | Solid forms of (r)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-n-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1h-indol-5-yl) cyclopropanecarboxamide | ⤷ Sign Up |
| Hong Kong | 1256805 | ⤷ Sign Up | |
| South Africa | 201406233 | PHARMACEUTICAL COMPOSITION AND ADMINISTRATION THEREOF | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1773816 | 2015/036 | Ireland | ⤷ Sign Up | 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 | 300748 | Netherlands | ⤷ Sign Up | 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 |
| 1773816 | 15C0045 | France | ⤷ Sign Up | PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
| 1773816 | 237 5014-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
