Product profile · United States

KALYDECO

· Patent Litigation & Settlement History ↓

IngredientIVACAFTOR

Application typeNDA

Application207925

Product003

Dosage formGRANULE

RouteORAL

Strength25MG/PACKET

Approval date2019-04-29

Marketing statusPrescription

Status event—

ApplicantVERTEX PHARMS INC

Product source

Current GenericRadar decision

Year2028

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeDS_EQUIVALENT_PATENT

Anchor date2028-02-05

Patent anchor2028-02-05

Exclusivity anchor2022-03-17

Protection date2033-08-27

First Final ANDA—

Status event—

Canonical 2028-02-05; DEEP_REVIEW; latest post-anchor right 2033-08-27; Final exact ANDA link not identified; not certified generic absence.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8354427	2026-07-06	U U-1905	—	—	—	—	—	—
8354427	2026-07-06	U U-2964	—	—	—	—	—	—
8354427	2026-07-06	U U-1311	—	—	—	—	—	—
8410274	2026-12-28	DP —	—	—	—	—	—	—
8754224	2026-12-28	DS/DP —	—	—	—	—	—	—
9670163	2026-12-28	DP/U U-1311	—	—	—	—	—	—
9670163	2026-12-28	DP/U U-2966	—	—	—	—	—	—
8354427	2027-01-06	— —	—	—	—	—	2027-01-06	—
8354427	2027-01-06	ORANGE_BOOK U-1311,U-1905,U-2964	N	N	U English description not available.	—	2027-01-06	—
7495103	2027-05-20	DS/DP —	—	—	—	—	—	—
8410274	2027-06-28	— —	—	—	—	—	2027-06-28	—
8410274	2027-06-28	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2027-06-28	—
8754224	2027-06-28	— —	—	—	—	—	2027-06-28	—
8754224	2027-06-28	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2027-06-28	—
9670163	2027-06-28	— —	—	—	—	—	2027-06-28	—
9670163	2027-06-28	ORANGE_BOOK U-1311,U-2966	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2027-06-28	—
8324242	2027-08-05	U U-2963	—	—	—	—	—	—
8324242	2027-08-05	U U-1906	—	—	—	—	—	—
8324242	2027-08-05	U U-1311	—	—	—	—	—	—
7495103	2027-11-20	— —	—	—	—	—	2027-11-20	—
7495103	2027-11-20	ORANGE_BOOK —	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2027-11-20	—
8324242	2028-02-05	— —	—	—	—	—	2028-02-05	—
8324242	2028-02-05	ORANGE_BOOK U-1311,U-1906,U-2963	N	Y	DS_EQUIVALENT Claim 1: ivacaftor treatment of CF, no age/genotype or solid-form restriction; the ORKAMBI indication is a subset.	—	2028-02-05	—
10646481	2029-08-13	DP —	—	—	—	—	—	—
11564916	2029-08-13	U U-3528	—	—	—	—	—	—
12458635	2029-08-13	DP/U U-4337	—	—	—	—	—	—
10646481	2030-02-13	— —	—	—	—	—	2030-02-13	—
10646481	2030-02-13	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2030-02-13	—
11564916	2030-02-13	— —	—	—	—	—	2030-02-13	—
11564916	2030-02-13	ORANGE_BOOK U-3528	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2030-02-13	—
12458635	2030-02-13	— —	—	—	—	—	2030-02-13	—
12458635	2030-02-13	ORANGE_BOOK U-4337	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2030-02-13	—
10272046	2033-02-27	DP/U U-2967	—	—	—	—	—	—
11147770	2033-02-27	DP/U U-3339	—	—	—	—	—	—
11752106	2033-02-27	DP/U U-3697	—	—	—	—	—	—
12214083	2033-02-27	DP/U U-4128	—	—	—	—	—	—
8883206	2033-02-27	DP —	—	—	—	—	—	—
10272046	2033-08-27	— —	—	—	—	—	2033-08-27	—
10272046	2033-08-27	ORANGE_BOOK U-2967	N	N	DP English description not available.	—	2033-08-27	—
11147770	2033-08-27	— —	—	—	—	—	2033-08-27	—
11147770	2033-08-27	ORANGE_BOOK U-3339	N	N	DP English description not available.	—	2033-08-27	—
11752106	2033-08-27	— —	—	—	—	—	2033-08-27	—
11752106	2033-08-27	ORANGE_BOOK U-3697	N	N	DP English description not available.	—	2033-08-27	—
12214083	2033-08-27	— —	—	—	—	—	2033-08-27	—
12214083	2033-08-27	ORANGE_BOOK U-4128	N	N	DP English description not available.	—	2033-08-27	—
8883206	2033-08-27	— —	—	—	—	—	2033-08-27	—
8883206	2033-08-27	ORANGE_BOOK —	N	N	DP English description not available.	—	2033-08-27	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NPP	2017-07-31	2020-07-31	English description not available.	N	N	—		Source
ODE-188	2015-03-17	2022-03-17	TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGES 2 TO LESS THAN 6 YEARS WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, AND R117H	N	N	—		Source
NPP	2019-04-29	2022-04-29	English description not available.	N	N	—		Source
ODE-190	2017-05-17	2024-05-17	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	N	N	—		Source
ODE-189	2017-07-31	2024-07-31	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	N	N	—		Source
ODE-199	2018-08-15	2025-08-15	English description not available.	N	N	—		Source
ODE-236	—	2026-04-29		—	—	—	—	Source
ODE-236	2019-04-29	2026-04-29	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	N	N	—		Source
PED	—	2026-10-29		—	—	—	—	Source
PED	2026-04-29	2026-10-29	English description not available.	N	N	—		Source
OOPD-20200924	2020-09-24	2027-09-24	English description not available.	N	N	—		Source
ODE-338	—	2027-12-21		—	—	—	—	Source
ODE-338	2020-12-21	2027-12-21	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	N	N	—		Source
M-14	—	2028-05-22		—	—	—	—	Source
M-14	2025-05-22	2028-05-22	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION	N	N	—		Source
PED	—	2028-06-21		—	—	—	—	Source
PED	2027-12-21	2028-06-21	English description not available.	N	N	—		Source
PED	—	2028-11-22		—	—	—	—	Source
PED	2028-05-22	2028-11-22	English description not available.	N	N	—		Source
ODE-435	2023-05-03	2030-05-03	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	N	N	—		Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (29)

Type	Date	Role	Basis	Source
PATENT	2027-01-06	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-06-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2027-06-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2027-06-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2027-11-20	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2028-02-05	CANONICAL_ANCHOR	Claim 1: ivacaftor treatment of CF, no age/genotype or solid-form restriction; the ORKAMBI indication is a subset.	Source
PATENT	2030-02-13	FTO_TAIL	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2030-02-13	FTO_TAIL	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2030-02-13	FTO_TAIL	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2033-08-27	FTO_TAIL	English description not available.	Source
PATENT	2033-08-27	FTO_TAIL	English description not available.	Source
PATENT	2033-08-27	FTO_TAIL	English description not available.	Source
PATENT	2033-08-27	FTO_TAIL	English description not available.	Source
PATENT	2033-08-27	FTO_TAIL	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	FTO_TAIL	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGES 2 TO LESS THAN 6 YEARS WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, AND R117H	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	FTO_TAIL	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	FTO_TAIL	English description not available.	Source
REGULATORY_STATUS	2028-02-05	CANONICAL_DECISION	Canonical 2028-02-05; DEEP_REVIEW; latest post-anchor right 2033-08-27; Final exact ANDA link not identified; not certified generic absence.	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.