DrugPatentWatch Database Preview
ORKAMBI Drug Profile
» See Plans and Pricing
Which patents cover Orkambi, and when can generic versions of Orkambi launch?
Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are eighteen patents protecting this drug.
This drug has three hundred and forty-four patent family members in thirty-five 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.
US ANDA Litigation and Generic Entry Outlook for Orkambi
Orkambi was eligible for patent challenges on July 2, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 11, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ORKAMBI
| International Patents: | 344 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 16 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information for ORKAMBI |
| DailyMed Link: | ORKAMBI at DailyMed |
Generic Entry Opportunity Date for ORKAMBI
Generic Entry Dates for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL |
Generic Entry Dates for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
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.
Recent Clinical Trials for ORKAMBI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | N/A |
| University of Miami | Early Phase 1 |
| University of North Carolina | Early Phase 1 |
Pharmacology for ORKAMBI
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-002 | Aug 7, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | Start Trial | Start Trial | Start 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 ORKAMBI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20140009566 | Start Trial |
| Montenegro | 02970 | Start Trial |
| China | 103626744 | Start Trial |
| China | 106943403 | Start Trial |
| Australia | 2010251787 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ORKAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2404919 | C20160015 00195 | Estonia | Start Trial | PRODUCT NAME: LUMAKAFTOOR / IVAKAFTOOR;REG NO/DATE: EU/1/15/1059 24.11.2015 |
| 2404919 | CA 2016 00019 | Denmark | Start Trial | PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCATBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOSYRE, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET ESTERPRODRUG DERAF; REG. NO/DATE: EU/1/15/1059 20151124 |
| 1773816 | 15C0045 | France | Start Trial | PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
| 1773816 | C300748 | Netherlands | Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
