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KALYDECO Drug Patent Profile

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

Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and fifty-three patent family members in thirty-two countries.

The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.

DrugPatentWatch^® Generic Entry Outlook for Kalydeco

Kalydeco was eligible for patent challenges on January 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 13, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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.

There is one tentative approval for the generic drug (ivacaftor), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for KALYDECO

International Patents:	253
US Patents:	13
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	26
Patent Applications:	806
Drug Prices:	Drug price information for KALYDECO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KALYDECO
What excipients (inactive ingredients) are in KALYDECO?	KALYDECO excipients list
DailyMed Link:	KALYDECO at DailyMed

Drug patent expirations by year for KALYDECO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KALYDECO

Generic Entry Dates for KALYDECO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 207925 Dosage: GRANULE;ORAL
Generic Entry Dates for KALYDECO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203188 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 KALYDECO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
University of Kansas Medical Center	Early Phase 1
University of North Carolina	Early Phase 1

See all KALYDECO clinical trials

Pharmacology for KALYDECO

Drug Class	Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Mechanism of Action	Chloride Channel Activation Potentiators Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for KALYDECO

R07AX	Other respiratory system products
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

Paragraph IV (Patent) Challenges for KALYDECO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KALYDECO	Oral Granules	ivacaftor	25 mg, 50 mg and 75 mg	207925	1	2022-04-13
KALYDECO	Tablets	ivacaftor	150 mg	203188	1	2020-06-10

US Patents and Regulatory Information for KALYDECO

KALYDECO is protected by thirty-two US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KALYDECO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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 KALYDECO

Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO

Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO

Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO

Pharmaceutical composition and administrations thereof
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Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO

Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO

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Patented Use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO

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Patented Use: TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO

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Patented Use: TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916

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Patented Use: TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO

Modulators of ATP-binding cassette transporters
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO

Modulators of ATP-binding cassette transporters
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Patented Use: METHOD OF TREATING CYSTIC FIBROSIS

Modulators of ATP-binding cassette transporters
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Patented Use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, SUCH AS A PATIENT HAVING A G551D MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE

Modulators of ATP-binding cassette transporters
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Patented Use: METHOD OF TREATING CYSTIC FIBROSIS

Modulators of ATP-binding cassette transporters
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Patented Use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO

Modulators of ATP-binding cassette transporters
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Patented Use: USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷ Sign Up
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Pharmaceutical composition and administrations thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO < 6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR

FDA Regulatory Exclusivity protecting KALYDECO

THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 1 MONTH TO LESS THAN 4 MONTHS OF AGE WHO HAVE AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
Exclusivity Expiration: ⤷ Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 MONTHS TO LESS THAN 12 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
Exclusivity Expiration: ⤷ Sign Up

TX OF CF IN PTS 2 YRS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
Exclusivity Expiration: ⤷ Sign Up

THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
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TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T
Exclusivity Expiration: ⤷ Sign Up

FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertex Pharms	KALYDECO	ivacaftor	TABLET;ORAL	203188-001	Jan 31, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 KALYDECO

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vertex Pharmaceuticals (Ireland) Limited	Kalydeco	ivacaftor	EMEA/H/C/002494 Kalydeco tablets are indicated:As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.In a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene (see section 5.1).Kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).	Authorised	no	no	no	2012-07-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for KALYDECO

When does loss-of-exclusivity occur for KALYDECO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09282419
Estimated Expiration: ⤷ Sign Up

Patent: 10282986
Estimated Expiration: ⤷ Sign Up

Patent: 13226076
Estimated Expiration: ⤷ Sign Up

Patent: 16216569
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2014021090
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Canada

Patent: 65519
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China

Patent: 4470518
Estimated Expiration: ⤷ Sign Up

Patent: 9966264
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European Patent Office

Patent: 19670
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 03840
Estimated Expiration: ⤷ Sign Up

Patent: 05690
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Israel

Patent: 4307
Estimated Expiration: ⤷ Sign Up

Patent: 5430
Estimated Expiration: ⤷ Sign Up

Patent: 1180
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 34041
Estimated Expiration: ⤷ Sign Up

Patent: 15511583
Estimated Expiration: ⤷ Sign Up

Patent: 17190356
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 14010253
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 9199
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 92779
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Patent: 14139006
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Patent: 19116577
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South Africa

Patent: 1406233
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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 KALYDECO around the world.

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Country	Patent Number	Title	Estimated Expiration
Ukraine	102261	ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ОСНОВІ ТВЕРДОЇ ДИСПЕРСІЇ N-[2,4-БІС(1,1-ДИМЕТИЛЕТИЛ)-5-ГІДРОКСИФЕНІЛ]-1,4-ДИГІДРО-4-ОКСОХІНОЛІН-3-КАРБОКСАМІДУ[ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИЯ НА ОСНОВЕ ТВЕРДОЙ ДИСПЕРСИИ N-[2,4-БИС(1,1-ДИМЕТИЛЭТИЛ)-5-ГИДРОКСИФЕНИЛ]-1,4-ДИГИДРО-4-ОКСОХИНОЛИН-3-КАРБОКСАМИДА (PHARMACEUTICAL COMPOSITIONS COMPRISING A SOLID DISPERSION OF N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE)	⤷ Sign Up
Denmark	2502911		⤷ Sign Up
Lithuania	1993360		⤷ Sign Up
Canada	2635581	FORMES SOLIDES DE N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4-OXOQUINOLEINE-3-CARBOXAMIDE (SOLID FORMS OF N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE)	⤷ Sign Up
Russian Federation	2009141996	МОДУЛЯТОРЫ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ	⤷ Sign Up
New Zealand	598393	Modulators of atp-binding cassette transporters	⤷ Sign Up
Australia	2010327993	4-oxo-1H-quinoline-3-carboxamides as modulators of ATP-Binding cassette transporters	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for KALYDECO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3170818	C202030042	Spain	⤷ Sign Up	PRODUCT NAME: UNA COMBINACION DE A) LUMACAFTOR Y B) IVACAFTOR; NATIONAL AUTHORISATION NUMBER: EU/1/15/1059; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1059; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1773816	92761	Luxembourg	⤷ Sign Up	PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
1773816	PA2015028	Lithuania	⤷ Sign Up	PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
2826776	132021000000062	Italy	⤷ Sign Up	PRODUCT NAME: UNA COMBINAZIONE DI (A) TEZACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SYMKEVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1306, 20181106
2826776	2021C/517	Belgium	⤷ Sign Up	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
1773816	C300748	Netherlands	⤷ Sign Up	PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816	2015/036	Ireland	⤷ Sign Up	PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description