Keytruda Qlex
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2043. Anchor type: DRUG_SUBSTANCE. Patent anchor: 2043-05-25. Exclusivity anchor: 2026-09-04. Anchor date: 2043-05-25. Patent tail: no. Exclusivity tail: no. Review status: FINAL_CHECKING. 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 |
|---|---|---|---|---|---|---|---|---|
| US8900587 | 2028-08-22 | — — | Y | N | TRUE_DS_SCOPE_SUPPORTED English description not available. | — | — | — |
| US8354509 | 2028-12-06 | — — | Y | N | TRUE_DS_SCOPE_SUPPORTED English description not available. | — | — | — |
| US9834605 | 2029-05-14 | — — | N | N | PROCESS_NON_DS English description not available. | — | — | — |
| US11117961 | 2029-11-09 | — — | N | Y | DS_EQUIVALENT_SCOPE_SUPPORTED English description not available. | — | — | — |
| US11633476 | 2039-10-14 | — — | N | N | DP_NON_DS English description not available. | — | — | — |
| US12371683 | 2043-01-03 | — — | Y | N | TRUE_DS_COMPONENT_SCOPE_SUPPORTED English description not available. | — | — | — |
| US12570766 | 2043-05-25 | — — | Y | N | COMBINATION_SCOPE_SUPPORTED English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE | 2014-09-04 | 2021-09-04 | N | N | — | — | Source | |
| ODE | 2017-09-22 | 2022-02-04 | N | N | — | — | Source | |
| ODE | 2015-12-18 | 2022-12-18 | N | N | — | — | Source | |
| ODE | 2018-11-09 | 2025-11-09 | N | N | — | — | Source | |
| ODE | 2019-02-15 | 2026-02-15 | N | N | — | — | Source | |
| ODE | 2019-07-30 | 2026-07-30 | N | N | — | — | Source | |
| RPE_BASELINE | 2014-09-04 | 2026-09-04 | Full-product 12-year operational assumption; not FDA determination | Y | Y | — | — | Source |
| ODE | 2021-03-22 | 2028-03-22 | N | N | — | — | Source | |
| ODE | 2021-05-05 | 2028-05-05 | N | N | — | — | Source | |
| ODE | 2021-12-03 | 2028-12-03 | N | N | — | — | Source | |
| ODE | 2023-10-31 | 2030-10-31 | N | N | — | — | Source | |
| ODE | 2023-11-16 | 2030-11-16 | N | N | — | — | Source | |
| ODE | 2024-01-25 | 2031-01-25 | N | N | — | — | Source |
2026-10-10 · PENDING_EXCLUSIVITY_CONFIRMATION · 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 (20)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-08-22 | OTHER_RIGHT_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| PATENT | 2028-12-06 | OTHER_RIGHT_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| PATENT | 2029-05-14 | OTHER_RIGHT_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| PATENT | 2029-11-09 | OTHER_RIGHT_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| PATENT | 2039-10-14 | OTHER_RIGHT_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| PATENT | 2043-01-03 | OTHER_RIGHT_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| PATENT | 2043-05-25 | ANCHOR_REFERENCE | Classification includes excluded and conditional scope; use payload; current official term pending | Source |
| REGULATORY_EXCLUSIVITY | 2021-09-04 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2022-02-04 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2022-12-18 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2025-11-09 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2026-02-15 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2026-07-30 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2026-09-04 | SCOPE_HISTORY | User-adopted operational baseline; inherited dates do not restart RPE; not FDA determination | Source |
| REGULATORY_EXCLUSIVITY | 2028-03-22 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-05-05 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-12-03 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-10-31 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-11-16 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2031-01-25 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
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.