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 patents protecting this drug.
This drug has four hundred and fifty-six 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: | 456 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 18 |
| Patent Applications: | 32 |
| 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 |
|---|---|
| Children's Hospital Medical Center, Cincinnati | N/A |
| University of North Carolina | Early Phase 1 |
| University of Miami | Early Phase 1 |
Pharmacology for ORKAMBI
Anatomical Therapeutic Chemical (ATC) Classes for ORKAMBI
US Patents and Regulatory Information for ORKAMBI
ORKAMBI is protected by thirty-four US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORKAMBI is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ORKAMBI
Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 12 YEARS OR OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1, 19, OR 21 OF U.S. PATENT NO. 10,076,513 AND IVACAFTOR
Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 2 TO 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
Pharmaceutical composition and administrations thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET ACCORDING TO CLAIM 1 OF U.S. PATENT NO. 11,052,075, WHERE THE TABLET FURTHER COMPRISES IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS USING N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE AND 3-(6-(1-2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR
Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338
Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE.
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND LUMACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING A DOSAGE UNIT AS DEFINED IN CLAIM 1 OF U.S. PATENT NO. 9,192,606
Modulators of ATP-binding cassette transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT AGE 6 OR OLDER HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
FDA Regulatory Exclusivity protecting ORKAMBI
FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR F508DEL MUTATION IN THE CFTR GENE
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
Exclusivity Expiration: See Plans and Pricing
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/003954 Orkambi 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 2 years and older who are homozygous for the F508del mutation in the CFTR gene., |
Authorised | no | no | no | 2015-11-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ORKAMBI
When does loss-of-exclusivity occur for ORKAMBI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05210474
Estimated Expiration: See Plans and Pricing
Patent: 06311650
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0507278
Estimated Expiration: See Plans and Pricing
Canada
Patent: 54796
Estimated Expiration: See Plans and Pricing
Patent: 27358
Estimated Expiration: See Plans and Pricing
China
Patent: 38279
Estimated Expiration: See Plans and Pricing
Patent: 1356170
Estimated Expiration: See Plans and Pricing
Patent: 2775396
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 14727
Estimated Expiration: See Plans and Pricing
Patent: 15750
Estimated Expiration: See Plans and Pricing
Patent: 16258
Estimated Expiration: See Plans and Pricing
Patent: 18768
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 45632
Estimated Expiration: See Plans and Pricing
Patent: 95002
Estimated Expiration: See Plans and Pricing
Patent: 04919
Estimated Expiration: See Plans and Pricing
Patent: 74925
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 16122
Estimated Expiration: See Plans and Pricing
Patent: 45632
Estimated Expiration: See Plans and Pricing
Patent: 95002
Estimated Expiration: See Plans and Pricing
Patent: 04919
Estimated Expiration: See Plans and Pricing
Patent: 74925
Estimated Expiration: See Plans and Pricing
Patent: 08272
Estimated Expiration: See Plans and Pricing
Patent: 19709
Estimated Expiration: See Plans and Pricing
Patent: 96174
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 04292
Estimated Expiration: See Plans and Pricing
Patent: 25366
Estimated Expiration: See Plans and Pricing
Patent: 78892
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 32640
Estimated Expiration: See Plans and Pricing
Patent: 600023
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1141
Estimated Expiration: See Plans and Pricing
Patent: 2784
Estimated Expiration: See Plans and Pricing
Japan
Patent: 60708
Estimated Expiration: See Plans and Pricing
Patent: 17184
Estimated Expiration: See Plans and Pricing
Patent: 66525
Estimated Expiration: See Plans and Pricing
Patent: 69319
Estimated Expiration: See Plans and Pricing
Patent: 40239
Estimated Expiration: See Plans and Pricing
Patent: 41095
Estimated Expiration: See Plans and Pricing
Patent: 58985
Estimated Expiration: See Plans and Pricing
Patent: 07519740
Estimated Expiration: See Plans and Pricing
Patent: 09514962
Estimated Expiration: See Plans and Pricing
Patent: 12077094
Estimated Expiration: See Plans and Pricing
Patent: 12233011
Estimated Expiration: See Plans and Pricing
Patent: 14088437
Estimated Expiration: See Plans and Pricing
Patent: 14139243
Estimated Expiration: See Plans and Pricing
Patent: 15091875
Estimated Expiration: See Plans and Pricing
Patent: 15134835
Estimated Expiration: See Plans and Pricing
Patent: 16153424
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 404919
Estimated Expiration: See Plans and Pricing
Patent: 74925
Estimated Expiration: See Plans and Pricing
Luxembourg
Patent: 073
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 06008606
Estimated Expiration: See Plans and Pricing
Netherlands
Patent: 0812
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 7892
Estimated Expiration: See Plans and Pricing
Norway
Patent: 082674
Estimated Expiration: See Plans and Pricing
Poland
Patent: 45632
Estimated Expiration: See Plans and Pricing
Patent: 95002
Estimated Expiration: See Plans and Pricing
Patent: 04919
Estimated Expiration: See Plans and Pricing
Patent: 74925
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 45632
Estimated Expiration: See Plans and Pricing
Patent: 95002
Estimated Expiration: See Plans and Pricing
Patent: 04919
Estimated Expiration: See Plans and Pricing
Patent: 74925
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 63303
Estimated Expiration: See Plans and Pricing
Patent: 08610
Estimated Expiration: See Plans and Pricing
Patent: 65714
Estimated Expiration: See Plans and Pricing
Patent: 08122929
Estimated Expiration: See Plans and Pricing
Patent: 12123372
Estimated Expiration: See Plans and Pricing
Patent: 16150386
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 45632
Estimated Expiration: See Plans and Pricing
Patent: 95002
Estimated Expiration: See Plans and Pricing
Patent: 04919
Estimated Expiration: See Plans and Pricing
Patent: 74925
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0803887
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1331768
Estimated Expiration: See Plans and Pricing
Patent: 1561482
Estimated Expiration: See Plans and Pricing
Patent: 080066086
Estimated Expiration: See Plans and Pricing
Patent: 130034062
Estimated Expiration: See Plans and Pricing
Patent: 130042034
Estimated Expiration: See Plans and Pricing
Patent: 140009566
Estimated Expiration: See Plans and Pricing
Patent: 150041174
Estimated Expiration: See Plans and Pricing
Patent: 160067985
Estimated Expiration: See Plans and Pricing
Spain
Patent: 31388
Estimated Expiration: See Plans and Pricing
Patent: 39736
Estimated Expiration: See Plans and Pricing
Patent: 01594
Estimated Expiration: See Plans and Pricing
Patent: 19608
Estimated Expiration: See Plans and Pricing
Patent: 31362
Estimated Expiration: See Plans and Pricing
Patent: 78846
Estimated Expiration: See Plans and Pricing
Patent: 91303
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ORKAMBI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E035931 | See Plans and Pricing | |
| European Patent Office | 3216787 | INTERMÉDIAIRES POUR LA PRÉPARATION DE MODULATEURS DE TRANSPORTEURS DE CASSETTE À LIAISON ATP (INTERMEDIATES FOR THE PREPARATION OF MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) | See Plans and Pricing |
| New Zealand | 702159 | Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid | See Plans and Pricing |
| South Korea | 20190143497 | 제약 조성물 및 그의 투여 (PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS THEREOF) | See Plans and Pricing |
| Portugal | 2404919 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORKAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404919 | 132016000049236 | Italy | See Plans and Pricing | PRODUCT NAME: LUMACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, O UN SUO ESTERE PROFARMACO(ORKAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1059/001, 20151124 |
| 2404919 | 1690018-5 | Sweden | See Plans and Pricing | PRODUCT NAME: 3-6-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYLAMINO-3-METHYLPYRIDIN-2-YLBENZOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER THEREOF.; REG. NO/DATE: EU/1/15/1059 20151124 |
| 2404919 | CR 2016 00019 | Denmark | See Plans and Pricing | 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 |
| 2404919 | SPC/GB16/026 | United Kingdom | See Plans and Pricing | PRODUCT NAME: LUMACAFTOR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER PRODRUG THEREOF; REGISTERED: UK EU/1/15/1059/001 20151124; UK EU/1/15/1059/002 20151124 |
| 2826776 | C02826776/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: TEZACAFTOR UND IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66742 10.05.2019 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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