ORKAMBI Drug Patent 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 twenty-two patents protecting this drug.
This drug has four hundred and sixty-six patent family members in thirty-six 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 June 11, 2031. This may change due to patent challenges or generic licensing.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ORKAMBI?
- What are the global sales for ORKAMBI?
- What is Average Wholesale Price for ORKAMBI?
Summary for ORKAMBI
| International Patents: | 466 |
| US Patents: | 22 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 19 |
| Patent Applications: | 176 |
| Drug Prices: | Drug price information for ORKAMBI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ORKAMBI |
| What excipients (inactive ingredients) are in ORKAMBI? | ORKAMBI excipients list |
| DailyMed Link: | ORKAMBI at DailyMed |

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| Qanatpharma Canada LTD | Phase 1 |
| Children's Hospital Medical Center, Cincinnati | N/A |
| University of North Carolina | Early Phase 1 |
Pharmacology for ORKAMBI
US Patents and Regulatory Information for ORKAMBI
ORKAMBI is protected by twenty-two US patents and seven FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORKAMBI is ⤷ Get Started Free.
This potential generic entry date is based on patent 8,993,600.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | GRANULE;ORAL | 211358-002 | Aug 7, 2018 | RX | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | 9,931,334*PED | ⤷ Get Started Free | Y | ⤷ Get Started Free | |||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-001 | Aug 7, 2018 | RX | Yes | No | 9,192,606*PED | ⤷ 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 |
EU/EMA Drug Approvals for ORKAMBI
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharmaceuticals (Ireland) Limited | Orkambi | lumacaftor, ivacaftor | EMEA/H/C/003954Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. | Authorised | no | no | no | 2015-11-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ORKAMBI
See the table below for patents covering ORKAMBI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2008504291 | ⤷ Get Started Free | |
| Spain | 2778846 | ⤷ Get Started Free | |
| Canada | 2635581 | ⤷ Get Started Free | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORKAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1773816 | 617 | Finland | ⤷ Get Started Free | |
| 3170818 | 122020000044 | Germany | ⤷ Get Started Free | PRODUCT NAME: KOMBINATION AUS (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)CYCLOPROPAN-CARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE UND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1059 20151119 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for ORKAMBI
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