Product profile · United States

ORKAMBI

· Patent Litigation & Settlement History ↓

IngredientIVACAFTOR; LUMACAFTOR

Application typeNDA

Application211358

Product002

Dosage formGRANULE

RouteORAL

Strength188MG/PACKET;150MG/PACKET

Approval date2018-08-07

Marketing statusPrescription

Status event—

ApplicantVERTEX PHARMS INC

Product source

Current GenericRadar decision

Year2031

SelectionCANDIDATE

ReviewFINAL

Anchor typeDS_EQUIVALENT_PATENT

Anchor date2031-06-11

Patent anchor2031-06-11

Exclusivity anchor2025-08-07

Protection date2031-06-11

First Final ANDA—

Status event—

Canonical 2031-06-11; CANDIDATE; latest post-anchor right NO_POST_ANCHOR_TAIL; 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
7973038	2026-11-08	U U-2374	—	—	—	—	—	—
8741933	2026-11-08	U U-2374	—	—	—	—	—	—
9216969	2026-11-08	DP —	—	—	—	—	—	—
8410274	2026-12-28	DP —	—	—	—	—	—	—
8754224	2026-12-28	DS/DP —	—	—	—	—	—	—
9670163	2026-12-28	DP/U U-2376	—	—	—	—	—	—
9931334	2026-12-28	DP/U U-2376	—	—	—	—	—	—
7973038	2027-05-08	— —	—	—	—	—	2027-05-08	—
7973038	2027-05-08	ORANGE_BOOK U-2374	N	Y	DS_EQUIVALENT English description not available.	—	2027-05-08	—
8741933	2027-05-08	— —	—	—	—	—	2027-05-08	—
8741933	2027-05-08	ORANGE_BOOK U-2374	N	Y	DS_EQUIVALENT English description not available.	—	2027-05-08	—
9216969	2027-05-08	— —	—	—	—	—	2027-05-08	—
9216969	2027-05-08	ORANGE_BOOK —	N	Y	DS_EQUIVALENT English description not available.	—	2027-05-08	—
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-2376	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2027-06-28	—
9931334	2027-06-28	— —	—	—	—	—	2027-06-28	—
9931334	2027-06-28	ORANGE_BOOK U-2376	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2027-06-28	—
8324242	2027-08-05	U U-2374	—	—	—	—	—	—
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-2374	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	—
10597384	2028-12-04	DS/DP/U U-2778	—	—	—	—	—	—
12065432	2028-12-04	U U-3983	—	—	—	—	—	—
8653103	2028-12-04	DP —	—	—	—	—	—	—
9150552	2028-12-04	U U-2375	—	—	—	—	—	—
10597384	2029-06-04	— —	—	—	—	—	2029-06-04	—
10597384	2029-06-04	ORANGE_BOOK U-2778	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2029-06-04	—
12065432	2029-06-04	— —	—	—	—	—	2029-06-04	—
12065432	2029-06-04	ORANGE_BOOK U-3983	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2029-06-04	—
8653103	2029-06-04	— —	—	—	—	—	2029-06-04	—
8653103	2029-06-04	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2029-06-04	—
9150552	2029-06-04	— —	—	—	—	—	2029-06-04	—
9150552	2029-06-04	ORANGE_BOOK U-2375	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2029-06-04	—
8846718	2029-07-02	U U-2375	—	—	—	—	—	—
10646481	2029-08-13	DP —	—	—	—	—	—	—
11564916	2029-08-13	U U-3526	—	—	—	—	—	—
12458635	2029-08-13	DP/U U-4335	—	—	—	—	—	—
9192606	2029-09-29	DP/U U-2397	—	—	—	—	—	—
8846718	2030-01-02	— —	—	—	—	—	2030-01-02	—
8846718	2030-01-02	ORANGE_BOOK U-2375	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2030-01-02	—
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-3526	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-4335	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2030-02-13	—
9192606	2030-03-29	— —	—	—	—	—	2030-03-29	—
9192606	2030-03-29	ORANGE_BOOK U-2397	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2030-03-29	—
8507534	2030-09-20	DS/DP —	—	—	—	—	—	—
8716338	2030-09-20	DP/U U-2396	—	—	—	—	—	—
8993600	2030-12-11	DP —	—	—	—	—	—	—
8507534	2031-03-20	— —	—	—	—	—	2031-03-20	—
8507534	2031-03-20	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2031-03-20	—
8716338	2031-03-20	— —	—	—	—	—	2031-03-20	—
8716338	2031-03-20	ORANGE_BOOK U-2396	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2031-03-20	—
8993600	2031-06-11	— —	—	—	—	—	2031-06-11	—
8993600	2031-06-11	ORANGE_BOOK —	N	Y	DS_EQUIVALENT Claim 1: published chemical structure is lumacaftor; the composition requires only an effective amount and any pharmaceutically acceptable carrier. No mandatory polymorph, specific excipient, age, ratio or indication limitation. Approved ORKAMBI granules contain lumacaftor and carriers. DS-equivalent on this specific structural and product match, not automatic DP promotion.	—	2031-06-11	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2015-07-02	2020-07-02	English description not available.	Y	Y	—		Source
NP	2018-08-07	2021-08-07	English description not available.	N	N	—		Source
ODE-195	2018-08-07	2025-08-07	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	N	N	—		Source
NPP	2022-09-02	2025-09-02	English description not available.	N	N	—		Source
M-14	—	2027-12-13		—	—	—	—	Source
M-14	2024-12-13	2027-12-13	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION	N	N	—		Source
PED	—	2028-06-13		—	—	—	—	Source
PED	2027-12-13	2028-06-13	English description not available.	N	N	—		Source
ODE-408	—	2029-09-02		—	—	—	—	Source
ODE-408	2022-09-02	2029-09-02	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	N	N	—		Source
PED	—	2030-03-02		—	—	—	—	Source
PED	2029-09-02	2030-03-02	English description not available.	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 (30)

Type	Date	Role	Basis	Source
PATENT	2027-05-08	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-05-08	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-05-08	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	2027-06-28	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	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	HISTORICAL_CONTEXT	Claim 1: ivacaftor treatment of CF, no age/genotype or solid-form restriction; the ORKAMBI indication is a subset.	Source
PATENT	2029-06-04	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2029-06-04	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2029-06-04	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2029-06-04	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2030-01-02	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2030-02-13	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2030-02-13	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2030-02-13	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2030-03-29	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-03-20	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-03-20	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-06-11	CANONICAL_ANCHOR	Claim 1: published chemical structure is lumacaftor; the composition requires only an effective amount and any pharmaceutically acceptable carrier. No mandatory polymorph, specific excipient, age, ratio or indication limitation. Approved ORKAMBI granules contain lumacaftor and carriers. DS-equivalent on this specific structural and product match, not automatic DP promotion.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	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	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	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	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_STATUS	2031-06-11	CANONICAL_DECISION	Canonical 2031-06-11; CANDIDATE; latest post-anchor right NO_POST_ANCHOR_TAIL; 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.