Product profile · United States
TRIKAFTA (COPACKAGED)
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2037. Anchor type: PATENT. Patent anchor: 2037-12-08. Exclusivity anchor: 2028-06-08. Anchor date: 2037-12-08. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8354427 | 2026-07-06 | U U-3145 | N | N | U English description not available. | — | — | — |
| 8354427 | 2026-07-06 | ORANGE_BOOK U-3145 | N | N | U English description not available. | — | — | — |
| 8410274 | 2026-12-28 | DP — | N | N | DP English description not available. | — | — | — |
| 8410274 | 2026-12-28 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8754224 | 2026-12-28 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 8754224 | 2026-12-28 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-4078 | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-4477 | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | DP/U U-3155 | N | N | DP English description not available. | — | — | — |
| 9670163 | 2026-12-28 | ORANGE_BOOK U-3155;U-4078;U-4477 | N | N | DP English description not available. | — | — | — |
| 9931334 | 2026-12-28 | DP/U U-3155 | N | N | U English description not available. | — | — | — |
| 9931334 | 2026-12-28 | DP/U U-4078 | N | N | U English description not available. | — | — | — |
| 9931334 | 2026-12-28 | DP/U U-4479 | N | N | U English description not available. | — | — | — |
| 9931334 | 2026-12-28 | ORANGE_BOOK U-3155;U-4078;U-4479 | N | N | U English description not available. | — | — | — |
| 10022352 | 2027-04-09 | DP/U U-3156 | N | N | U English description not available. | — | — | — |
| 10022352 | 2027-04-09 | ORANGE_BOOK U-3156 | N | N | U English description not available. | — | — | — |
| 10239867 | 2027-04-09 | DS/DP/U U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10239867 | 2027-04-09 | DS/DP/U U-4056 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10239867 | 2027-04-09 | DS/DP/U U-3158 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10239867 | 2027-04-09 | ORANGE_BOOK U-3158;U-4056;U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | DS/DP/U U-3587 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | DS/DP/U U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | DS/DP/U U-4056 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11639347 | 2027-04-09 | ORANGE_BOOK U-3587;U-4056;U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9974781 | 2027-04-09 | DP/U U-4073 | N | Y | U English description not available. | — | — | — |
| 9974781 | 2027-04-09 | DP/U U-3144 | N | Y | U English description not available. | — | — | — |
| 9974781 | 2027-04-09 | DP/U U-4475 | N | Y | U English description not available. | — | — | — |
| 9974781 | 2027-04-09 | ORANGE_BOOK U-3144;U-4073;U-4475 | N | Y | U English description not available. | — | — | — |
| 7645789 | 2027-05-01 | DS/DP — | N | N | TRUE_DS English description not available. | — | — | — |
| 7645789 | 2027-05-01 | ORANGE_BOOK — | N | N | TRUE_DS English description not available. | — | — | — |
| 8598181 | 2027-05-01 | U U-4056 | N | N | U English description not available. | — | — | — |
| 8598181 | 2027-05-01 | U U-4475 | N | N | U English description not available. | — | — | — |
| 8598181 | 2027-05-01 | U U-3144 | N | N | U English description not available. | — | — | — |
| 8598181 | 2027-05-01 | ORANGE_BOOK U-3144;U-4056;U-4475 | N | N | U English description not available. | — | — | — |
| 8623905 | 2027-05-01 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8623905 | 2027-05-01 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7495103 | 2027-05-20 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7495103 | 2027-05-20 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7776905 | 2027-06-03 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7776905 | 2027-06-03 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8324242 | 2027-08-05 | U U-3144 | N | Y | U English description not available. | — | — | — |
| 8324242 | 2027-08-05 | U U-4475 | N | Y | U English description not available. | — | — | — |
| 8324242 | 2027-08-05 | U U-4073 | N | Y | U English description not available. | — | — | — |
| 8324242 | 2027-08-05 | ORANGE_BOOK U-3144;U-4073;U-4475 | N | Y | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | U U-4475 | N | Y | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | U U-3144 | N | Y | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | U U-4073 | N | Y | U English description not available. | — | — | — |
| 8415387 | 2027-11-12 | ORANGE_BOOK U-3144;U-4073;U-4475 | N | Y | U English description not available. | — | — | — |
| 10646481 | 2029-08-13 | DP — | N | N | DP English description not available. | — | — | — |
| 10646481 | 2029-08-13 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11564916 | 2029-08-13 | U U-3525 | N | N | U English description not available. | — | — | — |
| 11564916 | 2029-08-13 | U U-4063 | N | N | U English description not available. | — | — | — |
| 11564916 | 2029-08-13 | U U-4491 | N | N | U English description not available. | — | — | — |
| 11564916 | 2029-08-13 | ORANGE_BOOK U-3525;U-4063;U-4491 | N | N | U English description not available. | — | — | — |
| 12458635 | 2029-08-13 | DP/U U-4330 | N | N | DP English description not available. | — | — | — |
| 12458635 | 2029-08-13 | DP/U U-4486 | N | N | DP English description not available. | — | — | — |
| 12458635 | 2029-08-13 | ORANGE_BOOK U-4330;U-4486 | N | N | DP English description not available. | — | — | — |
| 10081621 | 2031-03-25 | DP/U U-3157 | N | N | DP English description not available. | — | — | — |
| 10081621 | 2031-03-25 | DP/U U-4075 | N | N | DP English description not available. | — | — | — |
| 10081621 | 2031-03-25 | DP/U U-4480 | N | N | DP English description not available. | — | — | — |
| 10081621 | 2031-03-25 | ORANGE_BOOK U-3157;U-4075;U-4480 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | DP/U U-4490 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | DP/U U-3544 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | DP/U U-4054 | N | N | DP English description not available. | — | — | — |
| 11578062 | 2031-03-25 | ORANGE_BOOK U-3544;U-4054;U-4490 | N | N | DP English description not available. | — | — | — |
| RE50453 | 2031-07-10 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| RE50453 | 2031-07-10 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9012496 | 2033-07-15 | U U-3154 | N | N | U English description not available. | — | — | — |
| 9012496 | 2033-07-15 | ORANGE_BOOK U-3154 | N | N | U English description not available. | — | — | — |
| 10758534 | 2035-10-06 | DS/DP/U U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10758534 | 2035-10-06 | DS/DP/U U-3144 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10758534 | 2035-10-06 | DS/DP/U U-4073 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10758534 | 2035-10-06 | ORANGE_BOOK U-3144;U-4073;U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11426407 | 2035-10-06 | DS/DP/U U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11426407 | 2035-10-06 | DS/DP/U U-3425 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11426407 | 2035-10-06 | DS/DP/U U-4070 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11426407 | 2035-10-06 | ORANGE_BOOK U-3425;U-4070;U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10793547 | 2037-12-08 | DS/DP/U U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10793547 | 2037-12-08 | DS/DP/U U-4073 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10793547 | 2037-12-08 | DS/DP/U U-3144 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10793547 | 2037-12-08 | ORANGE_BOOK U-3144;U-4073;U-4475 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11179367 | 2037-12-08 | DP/U U-4487 | N | N | DP English description not available. | — | — | — |
| 11179367 | 2037-12-08 | DP/U U-3253 | N | N | DP English description not available. | — | — | — |
| 11179367 | 2037-12-08 | DP/U U-4071 | N | N | DP English description not available. | — | — | — |
| 11179367 | 2037-12-08 | ORANGE_BOOK U-3253;U-4071;U-4487 | N | N | DP English description not available. | — | — | — |
| 11453655 | 2037-12-08 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 11453655 | 2037-12-08 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11517564 | 2037-12-08 | DP/U U-4069 | N | Y | U English description not available. | — | — | — |
| 11517564 | 2037-12-08 | DP/U U-4475 | N | Y | U English description not available. | — | — | — |
| 11517564 | 2037-12-08 | DP/U U-3498 | N | Y | U English description not available. | — | — | — |
| 11517564 | 2037-12-08 | ORANGE_BOOK U-3498;U-4069;U-4475 | N | Y | U English description not available. | — | — | — |
| 12350262 | 2038-07-17 | U U-4222 | N | N | U English description not available. | — | — | — |
| 12350262 | 2038-07-17 | U U-4475 | N | N | U English description not available. | — | — | — |
| 12350262 | 2038-07-17 | ORANGE_BOOK U-4222;U-4475 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2018-02-12 | 2023-02-12 | English description not available. | Y | Y | 2023-02-12 | ODE-357 + ODE-512 + ODE-543
Full coverage date: 2023-02-12
| Source |
| NPP | 2021-06-08 | 2024-06-08 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| Source |
| NCE | 2019-10-21 | 2024-10-21 | English description not available. | Y | Y | 2024-10-21 | ODE-357 + ODE-512 + ODE-543
Full coverage date: 2024-10-21
| Source |
| ODE-275 | 2019-10-21 | 2026-10-21 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| Source |
| ODE* | — | 2026-10-21 | — | — | — | — | Source | |
| M-313 | 2024-12-20 | 2027-12-20 | English description not available. | N | N | — | — | Source |
| M-313 | 2024-12-20 | 2027-12-20 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| Source |
| ODE-323 | 2020-12-21 | 2027-12-21 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| Source |
| ODE* | — | 2027-12-21 | — | — | — | — | Source | |
| ODE-357 | 2021-06-08 | 2028-06-08 | English description not available. | N | N | — | — | Source |
| ODE-357 | 2021-06-08 | 2028-06-08 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| Source |
| ODE-512 | 2024-12-20 | 2031-12-20 | English description not available. | N | N | — | — | Source |
| ODE-512 | 2024-12-20 | 2031-12-20 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| Source |
| ODE-543 | 2026-03-27 | 2033-03-27 | English description not available. | N | N | — | — | Source |
| ODE-543 | 2026-03-27 | 2033-03-27 | English description not available. | N | N | — | ODE-357 + ODE-512 + ODE-543
Full coverage date: —
| 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 (40)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-07-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-05-01 | NOT_APPLICABLE_TO_EXACT_PRODUCT | English description not available. | Source |
| PATENT | 2027-05-01 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-05-01 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-05-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-06-03 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-08-05 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-08-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-08-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-08-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-03-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-03-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-07-10 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-07-15 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-10-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-10-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2037-12-08 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2037-12-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2037-12-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2037-12-08 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2038-07-17 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_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_EXCLUSIVITY | — | REGULATORY_SCOPE_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 | — | 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 | 2037-12-08 | CANONICAL_DECISION | English description not available. | 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.