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Last Updated: May 19, 2024

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ORKAMBI Drug Patent Profile


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Which patents cover Orkambi, and what generic alternatives are available?

Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are twenty-one 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

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Summary for ORKAMBI
International Patents:456
US Patents:21
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 2
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
Drug patent expirations by year for ORKAMBI
Drug Prices for ORKAMBI

See drug prices for ORKAMBI

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

SponsorPhase
Children's Hospital Medical Center, CincinnatiN/A
University of North CarolinaEarly Phase 1
University of MiamiEarly Phase 1

See all ORKAMBI clinical trials

US Patents and Regulatory Information for ORKAMBI

ORKAMBI is protected by forty-six US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORKAMBI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN A PATIENT AGE 1 TO


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

NEW STRENGTH
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

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 206038-002 Sep 28, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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/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 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
Canada 2706920 FORMES SOLIDES D'ACIDE 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL)CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIQUE (SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID) ⤷  Try a Trial
Canada 2881078 MODULATEURS DE TRANSPORTEURS DE CASSETTE DE LIAISON A L'ATP (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) ⤷  Try a Trial
Hong Kong 1152707 MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS ATP- ⤷  Try a Trial
Netherlands 300812 ⤷  Try a Trial
Cyprus 2016012 ⤷  Try a Trial
Croatia P20200664 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORKAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 92761 Luxembourg ⤷  Try a Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
2404919 132016000049236 Italy ⤷  Try a Trial 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
2826776 2021C/517 Belgium ⤷  Try a Trial PRODUCT NAME: SYMKEVI - TEZACAFTOR/IVACAFTOR; EEN COMBINATIE VAN (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
3170818 PA2020525 Lithuania ⤷  Try a Trial PRODUCT NAME: (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)CIKLOPROPANKARBOKSAMIDO)-3-METILPIRIDIN-2-IL)BENZENKARBOKSIRUGSTIES IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
2404919 16C0020 France ⤷  Try a Trial PRODUCT NAME: LUMACAFTOR, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SES PROMEDICAMENTS ESTERS; REGISTRATION NO/DATE: EU/1/15/1059 20151124
1773816 35/2015 Austria ⤷  Try a Trial PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725
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