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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 freedom to operate?
Ivacaftor; ivacaftor, tezacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; ivacaftor, tezacaftor has two hundred and three patent family members in twenty-eight countries.
There are three drug master file entries for ivacaftor; ivacaftor, tezacaftor. One supplier is listed for this compound.
Summary for ivacaftor; ivacaftor, tezacaftor
| International Patents: | 203 |
| US Patents: | 17 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 17 |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| 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 |
|---|---|---|
| Canada | 2783314 | ➤ Try a Free Trial |
| European Patent Office | 3091011 | ➤ Try a Free Trial |
| European Patent Office | 2509954 | ➤ Try a Free Trial |
| Mexico | 2012011062 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ivacaftor; ivacaftor, tezacaftor
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2015028,C1773816 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723 |
| 0748 | Netherlands | ➤ Try a Free 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 |
| 00748 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
| 761 | Luxembourg | ➤ Try a Free Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
