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ORKAMBI Drug Profile
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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 nineteen patents protecting this drug.
This drug has four hundred and thirty-three 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.
DrugPatentWatch® 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: | 433 |
| US Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 18 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information for ORKAMBI |
| What excipients (inactive ingredients) are in ORKAMBI? | ORKAMBI excipients list |
| DailyMed Link: | ORKAMBI at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| Istituto Auxologico Italiano | Phase 2 |
| Assistance Publique - Hôpitaux de Paris | N/A |
| 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 | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Get Started Free | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-002 | Aug 7, 2018 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| >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 |
|---|---|---|
| European Patent Office | 1255772 | Get Started Free |
| Hong Kong | 1105970 | Get Started Free |
| Australia | 2011237494 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ORKAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404919 | 249 5006-2016 | Slovakia | Get Started Free | PRODUCT NAME: LUMAKAFTOR; REGISTRATION NO/DATE: EU/1/15/1059 20151124 |
| 1773816 | 122015000050 | Germany | Get Started Free | 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 |
| 2404919 | PA2016015,C2404919 | Lithuania | Get Started Free | PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOKSOL-5-IL)CIKLOPROPANKARBONIL)AMINO)-3-METILPIRIDIN-2-IL)BENZOINE RUGSTIS ARBA JOS FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/15/1059 20151119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
