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Ivacaftor; ivacaftor, tezacaftor - Generic Drug Details
What are the generic sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of ivacaftor; ivacaftor, tezacaftor patent protection?
Ivacaftor; ivacaftor, tezacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for ivacaftor; ivacaftor, tezacaftor. One supplier is listed for this compound.
Summary for ivacaftor; ivacaftor, tezacaftor
| US Patents: | 16 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| DailyMed Link: | ivacaftor; ivacaftor, tezacaftor at DailyMed |
US Patents and Regulatory Information for ivacaftor; ivacaftor, tezacaftor
| 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 | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | 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 ivacaftor; ivacaftor, tezacaftor
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Poland | 2674428 | ➤ Sign Up |
| Russian Federation | 2008144124 | ➤ Sign Up |
| European Patent Office | 2502914 | ➤ Sign Up |
| Japan | 4947658 | ➤ Sign Up |
| Russian Federation | 2451018 | ➤ Sign Up |
| Hong Kong | 1209318 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ivacaftor; ivacaftor, tezacaftor
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| /2015 | Austria | ➤ Sign Up | 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 |
| 7 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 |
| 2015028 | Lithuania | ➤ Sign Up | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
| 2015000050 | Germany | ➤ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723 |
| 761 | Luxembourg | ➤ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725 |
| 2015 00038 | Denmark | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
