DrugPatentWatch Database Preview
ORKAMBI Drug Profile
When do Orkambi patents expire, and what generic alternatives are available?
Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are seventeen patents protecting this drug.
This drug has three hundred and twenty-three patent family members in thirty-four countries.
The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.
Summary for ORKAMBI
| International Patents: | 323 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 15 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information for ORKAMBI |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for ORKAMBI |
| DailyMed Link: | ORKAMBI at DailyMed |
Generic Entry Opportunity Date for ORKAMBI
*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.
Pharmacology for ORKAMBI
Synonyms for ORKAMBI
| 1815566-23-4 |
| Ivacaftor mixture with lumacaftor |
| Lumacaftor / Ivacaftor |
| Lumacaftor and ivacaftor tablet |
| Lumacaftor, ivacaftor drug combination |
| S900006790 |
| SCHEMBL19410545 |
| VX 700-VX 809 combination |
| VX 809-VX 770 combination |
US Patents and Regulatory Information for ORKAMBI
| 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 | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-002 | Aug 7, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | 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 ORKAMBI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 587548 | ➤ Sign Up |
| New Zealand | 552543 | ➤ Sign Up |
| Israel | 221827 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for ORKAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2404919 | 93073 | Luxembourg | ➤ Sign Up | PRODUCT NAME: ACIDE BENZOIQUE 3-{6-{-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5-YL)CYCLOPROPANECARBONYL AMINO}-3-METHYLPYRIDIN-2-YL}, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN PRO-MEDICAMENT DE TYPE ESTER DE CELUI-CI; FIRST REGISTRATION DATE: 20151124 |
| 1773816 | 1590036-8 | Sweden | ➤ Sign Up | 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 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
