Product profile · United States
KALYDECO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Canonical 2030-11-03; 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-3608 | — | — | — | — | — | — |
| 8410274 | 2026-12-28 | DP — | — | — | — | — | — | — |
| 8754224 | 2026-12-28 | DS/DP — | — | — | — | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-3606 | — | — | — | — | — | — |
| 8354427 | 2027-01-06 | — — | — | — | — | — | 2027-01-06 | — |
| 8354427 | 2027-01-06 | ORANGE_BOOK U-3608 | 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-3606 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2027-06-28 | — |
| 8324242 | 2027-08-05 | U U-3609 | — | — | — | — | — | — |
| 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-3609 | 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-3603 | — | — | — | — | — | — |
| 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-3603 | 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-3605 | — | — | — | — | — | — |
| 11147770 | 2033-02-27 | DP/U U-3604 | — | — | — | — | — | — |
| 11752106 | 2033-02-27 | DP/U U-3697 | — | — | — | — | — | — |
| 12214083 | 2033-02-27 | DP/U U-4127 | — | — | — | — | — | — |
| 8883206 | 2033-02-27 | DP — | — | — | — | — | — | — |
| 10272046 | 2033-08-27 | — — | — | — | — | — | 2033-08-27 | — |
| 10272046 | 2033-08-27 | ORANGE_BOOK U-3605 | N | N | DP English description not available. | — | 2033-08-27 | — |
| 11147770 | 2033-08-27 | — — | — | — | — | — | 2033-08-27 | — |
| 11147770 | 2033-08-27 | ORANGE_BOOK U-3604 | 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-4127 | 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 | — | 2026-05-03 | — | — | — | — | Source | |
| NPP | 2023-05-03 | 2026-05-03 | English description not available. | N | N | — | Source | |
| PED | — | 2026-11-03 | — | — | — | — | Source | |
| PED | 2026-05-03 | 2026-11-03 | English description not available. | 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 | — | 2028-11-22 | — | — | — | — | Source | |
| PED | 2028-05-22 | 2028-11-22 | English description not available. | N | N | — | Source | |
| ODE-435 | — | 2030-05-03 | — | — | — | — | 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 | Y | Y | 2030-05-03 | Source | |
| PED | — | 2030-11-03 | — | — | — | — | Source | |
| PED | 2030-05-03 | 2030-11-03 | English description not available. | Y | Y | 2030-11-03 | 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 (21)
| 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 | 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 | 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 | — | REGULATORY_SCOPE_CONTEXT | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_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 | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2030-11-03 | CANONICAL_DECISION | Canonical 2030-11-03; 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.