Product profile · United States
KALYDECO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8354427 | 2026-07-06 | U U-1905 | N | N | LIMITED_USE | — | — | — |
| 8354427 | 2026-07-06 | U U-1311 | N | N | LIMITED_USE | — | — | — |
| 8354427 | 2026-07-06 | U U-1905 | N | N | LIMITED_USE Ivacaftor cystic fibrosis treatment restricted to R117H CFTR mutation, not all label-responsive mutations. | — | — | — |
| 8354427 | 2026-07-06 | U U-1311 | N | N | LIMITED_USE Ivacaftor cystic fibrosis treatment restricted to R117H CFTR mutation, not all label-responsive mutations. | — | — | — |
| 8410274 | 2026-12-28 | DP — | N | N | AMORPHOUS_FORMULATION | — | — | — |
| 8410274 | 2026-12-28 | DP — | N | N | AMORPHOUS_FORMULATION Amorphous ivacaftor solid dispersion, with polymer or specific HPMCAS/SLS embodiments. | — | — | — |
| 8754224 | 2026-12-28 | DS/DP — | N | N | AMORPHOUS_FORMULATION | — | — | — |
| 8754224 | 2026-12-28 | DS/DP — | N | N | AMORPHOUS_FORMULATION Ivacaftor amorphous solid form/dispersion with polymer embodiments; not unrestricted molecule protection. | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-1311 | N | N | AMORPHOUS_FORMULATION_PROCESS | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-1311 | N | N | AMORPHOUS_FORMULATION_PROCESS Ivacaftor amorphous fraction/solid form and spray-drying process restrictions. | — | — | — |
| 8354427 | 2027-01-06 | — — | N | N | LIMITED_USE | — | 2027-01-06 | — |
| 8354427 | 2027-01-06 | PED — | N | N | LIMITED_USE Ivacaftor cystic fibrosis treatment restricted to R117H CFTR mutation, not all label-responsive mutations. | — | — | — |
| 7495103 | 2027-05-20 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 7495103 | 2027-05-20 | DS/DP — | Y | Y | TRUE_DS Independent claim 1 explicitly claims ivacaftor by chemical name or a pharmaceutically acceptable salt; no crystal, formulation or indication limit. | — | — | — |
| 8410274 | 2027-06-28 | — — | N | N | AMORPHOUS_FORMULATION | — | 2027-06-28 | — |
| 8410274 | 2027-06-28 | PED — | N | N | AMORPHOUS_FORMULATION Amorphous ivacaftor solid dispersion, with polymer or specific HPMCAS/SLS embodiments. | — | — | — |
| 8754224 | 2027-06-28 | — — | N | N | AMORPHOUS_FORMULATION | — | 2027-06-28 | — |
| 8754224 | 2027-06-28 | PED — | N | N | AMORPHOUS_FORMULATION Ivacaftor amorphous solid form/dispersion with polymer embodiments; not unrestricted molecule protection. | — | — | — |
| 9670163 | 2027-06-28 | — — | N | N | AMORPHOUS_FORMULATION_PROCESS | — | 2027-06-28 | — |
| 9670163 | 2027-06-28 | PED — | N | N | AMORPHOUS_FORMULATION_PROCESS Ivacaftor amorphous fraction/solid form and spray-drying process restrictions. | — | — | — |
| 8324242 | 2027-08-05 | U U-1311 | N | Y | DS_EQUIVALENT | — | — | — |
| 8324242 | 2027-08-05 | U U-1906 | N | Y | DS_EQUIVALENT | — | — | — |
| 8324242 | 2027-08-05 | U U-1906 | N | Y | DS_EQUIVALENT Independent claim 1 broadly treats or lessens cystic fibrosis with ivacaftor, without mutation, age or formulation restriction; G551D is dependent claim 2 only. | — | — | — |
| 8324242 | 2027-08-05 | U U-1311 | N | Y | DS_EQUIVALENT Independent claim 1 broadly treats or lessens cystic fibrosis with ivacaftor, without mutation, age or formulation restriction; G551D is dependent claim 2 only. | — | — | — |
| 7495103 | 2027-11-20 | — — | Y | Y | TRUE_DS | — | 2027-11-20 | — |
| 7495103 | 2027-11-20 | PED — | Y | Y | TRUE_DS Independent claim 1 explicitly claims ivacaftor by chemical name or a pharmaceutically acceptable salt; no crystal, formulation or indication limit. | — | — | — |
| 8324242 | 2028-02-05 | — — | N | Y | DS_EQUIVALENT | — | 2028-02-05 | — |
| 8324242 | 2028-02-05 | PED — | N | Y | DS_EQUIVALENT Independent claim 1 broadly treats or lessens cystic fibrosis with ivacaftor, without mutation, age or formulation restriction; G551D is dependent claim 2 only. | — | — | — |
| 10646481 | 2029-08-13 | DP — | N | N | FORMULATION | — | — | — |
| 10646481 | 2029-08-13 | DP — | N | N | FORMULATION Specified amorphous ivacaftor/HPMCAS/SLS solid dispersion proportions. | — | — | — |
| 11564916 | 2029-08-13 | U U-3530 | N | N | FORMULATION_USE | — | — | — |
| 11564916 | 2029-08-13 | U U-3530 | N | N | FORMULATION_USE CF treatment requires specified amorphous ivacaftor/HPMCAS/SLS solid dispersion or tablet excipient proportions. | — | — | — |
| 12458635 | 2029-08-13 | DP/U U-4339 | N | N | FORMULATION | — | — | — |
| 12458635 | 2029-08-13 | DP/U U-4339 | N | N | FORMULATION Ivacaftor single solid dispersion with specific amorphous loading and HPMCAS/SLS percentages. | — | — | — |
| 10646481 | 2030-02-13 | — — | N | N | FORMULATION | — | 2030-02-13 | — |
| 10646481 | 2030-02-13 | PED — | N | N | FORMULATION Specified amorphous ivacaftor/HPMCAS/SLS solid dispersion proportions. | — | — | — |
| 11564916 | 2030-02-13 | — — | N | N | FORMULATION_USE | — | 2030-02-13 | — |
| 11564916 | 2030-02-13 | PED — | N | N | FORMULATION_USE CF treatment requires specified amorphous ivacaftor/HPMCAS/SLS solid dispersion or tablet excipient proportions. | — | — | — |
| 12458635 | 2030-02-13 | — — | N | N | FORMULATION | — | 2030-02-13 | — |
| 12458635 | 2030-02-13 | PED — | N | N | FORMULATION Ivacaftor single solid dispersion with specific amorphous loading and HPMCAS/SLS percentages. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2012-01-31 | 2017-01-31 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2017-01-31 | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: 2017-01-31
| Source |
| I-740 | 2014-02-21 | 2017-02-21 | EXPANDED INDICATION FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER TO INCLUDE THE G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, OR S549R MUTATION IN THE CFTR GENE | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| I-705 | 2014-12-29 | 2017-12-30 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE | 2012-01-31 | 2019-01-31 | Original G551D CF population, age 6 years and older; historical unnumbered alias of ODE-20. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE-20 | 2012-01-31 | 2019-01-31 | CF with G551D mutation, age 6 years and older; excludes other current responsive mutations. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| NPP | 2017-07-31 | 2020-07-31 | 2017 expansion associated with additional splice mutations; original G551D and the complete current mutation list are not covered. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE-186 | 2014-02-21 | 2021-02-21 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, OR S549R | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE-187 | 2014-12-29 | 2021-12-29 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| 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 | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| 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 | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE-199 | 2018-08-15 | 2025-08-15 | Actual OOPD-protected use: CF patients aged 12 months to less than 2 years with a responsive mutation. The broad Orange Book description is not the protected population. Not applicable to the 150 mg tablet age-6-and-older population. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE-338 | 2020-12-21 | 2027-12-21 | Additional responsive CFTR mutations approved on 2020-12-21 only; does not cover all previously approved responsive mutations. Tablet-relevant patients are age 6 years and older. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| ODE-338 | 2020-12-21 | 2027-12-21 | Additional responsive CFTR mutations approved on 2020-12-21 only; does not cover all previously approved responsive mutations. Tablet-relevant patients are age 6 years and older. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| PED | 2027-12-21 | 2028-06-21 | Six-month extension of ODE-338: Additional responsive CFTR mutations approved on 2020-12-21 only; does not cover all previously approved responsive mutations. Tablet-relevant patients are age 6 years and older. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
| PED | 2027-12-21 | 2028-06-21 | Six-month extension of ODE-338: Additional responsive CFTR mutations approved on 2020-12-21 only; does not cover all previously approved responsive mutations. Tablet-relevant patients are age 6 years and older. | N | N | — | ODE-20 + ODE-186 + ODE-187 + ODE-189 + ODE-190 + ODE-338
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 216074 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 (34)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-07-06 | LISTING_CONTEXT | Ivacaftor cystic fibrosis treatment restricted to R117H CFTR mutation, not all label-responsive mutations. | Source |
| PATENT | 2026-07-06 | LISTING_CONTEXT | Ivacaftor cystic fibrosis treatment restricted to R117H CFTR mutation, not all label-responsive mutations. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ivacaftor amorphous solid form/dispersion with polymer embodiments; not unrestricted molecule protection. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ivacaftor amorphous fraction/solid form and spray-drying process restrictions. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Amorphous ivacaftor solid dispersion, with polymer or specific HPMCAS/SLS embodiments. | Source |
| PATENT | 2027-01-06 | LISTING_CONTEXT | Ivacaftor cystic fibrosis treatment restricted to R117H CFTR mutation, not all label-responsive mutations. | Source |
| PATENT | 2027-05-20 | LISTING_CONTEXT | Independent claim 1 explicitly claims ivacaftor by chemical name or a pharmaceutically acceptable salt; no crystal, formulation or indication limit. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Ivacaftor amorphous fraction/solid form and spray-drying process restrictions. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Amorphous ivacaftor solid dispersion, with polymer or specific HPMCAS/SLS embodiments. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Ivacaftor amorphous solid form/dispersion with polymer embodiments; not unrestricted molecule protection. | Source |
| PATENT | 2027-08-05 | LISTING_CONTEXT | Independent claim 1 broadly treats or lessens cystic fibrosis with ivacaftor, without mutation, age or formulation restriction; G551D is dependent claim 2 only. | Source |
| PATENT | 2027-08-05 | LISTING_CONTEXT | Independent claim 1 broadly treats or lessens cystic fibrosis with ivacaftor, without mutation, age or formulation restriction; G551D is dependent claim 2 only. | Source |
| PATENT | 2027-11-20 | LISTING_CONTEXT | Independent claim 1 explicitly claims ivacaftor by chemical name or a pharmaceutically acceptable salt; no crystal, formulation or indication limit. | Source |
| PATENT | 2028-02-05 | CANONICAL_ANCHOR | Independent claim 1 broadly treats or lessens cystic fibrosis with ivacaftor, without mutation, age or formulation restriction; G551D is dependent claim 2 only. | Source |
| PATENT | 2029-08-13 | FTO_TAIL | Specified amorphous ivacaftor/HPMCAS/SLS solid dispersion proportions. | Source |
| PATENT | 2029-08-13 | FTO_TAIL | Ivacaftor single solid dispersion with specific amorphous loading and HPMCAS/SLS percentages. | Source |
| PATENT | 2029-08-13 | FTO_TAIL | CF treatment requires specified amorphous ivacaftor/HPMCAS/SLS solid dispersion or tablet excipient proportions. | Source |
| PATENT | 2030-02-13 | FTO_TAIL | CF treatment requires specified amorphous ivacaftor/HPMCAS/SLS solid dispersion or tablet excipient proportions. | Source |
| PATENT | 2030-02-13 | FTO_TAIL | Specified amorphous ivacaftor/HPMCAS/SLS solid dispersion proportions. | Source |
| PATENT | 2030-02-13 | FTO_TAIL | Ivacaftor single solid dispersion with specific amorphous loading and HPMCAS/SLS percentages. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Actual OOPD-protected use: CF patients aged 12 months to less than 2 years with a responsive mutation. The broad Orange Book description is not the protected population. Not applicable to the 150 mg tablet age-6-and-older population. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, OR S549R | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | CF with G551D mutation, age 6 years and older; excludes other current responsive mutations. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Original G551D CF population, age 6 years and older; historical unnumbered alias of ODE-20. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | EXPANDED INDICATION FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER TO INCLUDE THE G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, OR S549R MUTATION IN THE CFTR GENE | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_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 | — | SCOPE_CONTEXT | Six-month extension of ODE-338: Additional responsive CFTR mutations approved on 2020-12-21 only; does not cover all previously approved responsive mutations. Tablet-relevant patients are age 6 years and older. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_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 | — | SCOPE_CONTEXT | Additional responsive CFTR mutations approved on 2020-12-21 only; does not cover all previously approved responsive mutations. Tablet-relevant patients are age 6 years and older. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | 2017 expansion associated with additional splice mutations; original G551D and the complete current mutation list are not covered. | Source |
| REGULATORY_EXCLUSIVITY | 2017-01-31 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2028-02-05 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | 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.