Product profile · United States
LYNPARZA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2027. Anchor type: PATENT. Patent anchor: 2027-09-08. Exclusivity anchor: 2020-08-17. Anchor date: 2027-09-08. 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 |
|---|---|---|---|---|---|---|---|---|
| 8071579 | 2027-08-12 | U U-2480 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2824 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-3333 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2821 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2832 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2823 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2716 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-3631 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-3695 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2482 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2833 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2820 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2822 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2819 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | U U-2483 | N | N | U English description not available. | — | — | — |
| 8071579 | 2027-08-12 | ORANGE_BOOK U-2480;U-2482;U-2483;U-2716;U-2819;U-2820;U-2821;U-2822;U-2823;U-2824;U-2832;U-2833;U-3333;U-3631;U-3695 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2832 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2824 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-3333 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2820 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2823 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2716 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-3631 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2822 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2483 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2821 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2819 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2833 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2482 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-2480 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | U U-3695 | N | N | U English description not available. | — | — | — |
| 8143241 | 2027-08-12 | ORANGE_BOOK U-2480;U-2482;U-2483;U-2716;U-2819;U-2820;U-2821;U-2822;U-2823;U-2824;U-2832;U-2833;U-3333;U-3631;U-3695 | N | N | U English description not available. | — | — | — |
| 7449464 | 2027-09-08 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7449464 | 2027-09-08 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11633396 | 2029-10-07 | DP — | N | N | DP English description not available. | — | — | — |
| 11633396 | 2029-10-07 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11975001 | 2029-10-07 | DP — | N | N | DP English description not available. | — | — | — |
| 11975001 | 2029-10-07 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12048695 | 2029-10-07 | DP — | N | N | DP English description not available. | — | — | — |
| 12048695 | 2029-10-07 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12144810 | 2029-10-07 | DP — | N | N | DP English description not available. | — | — | — |
| 12144810 | 2029-10-07 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12178816 | 2029-10-07 | DP — | N | N | DP English description not available. | — | — | — |
| 12178816 | 2029-10-07 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8475842 | 2029-12-31 | DP — | N | N | DP English description not available. | — | — | — |
| 8475842 | 2029-12-31 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-3333 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-3631 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2819 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2824 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-3695 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2833 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2822 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2821 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2716 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2101 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2103 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2823 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2832 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2820 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2480 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2482 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | U U-2483 | N | N | U English description not available. | — | — | — |
| 8859562 | 2031-08-04 | ORANGE_BOOK U-2101;U-2103;U-2480;U-2482;U-2483;U-2716;U-2819;U-2820;U-2821;U-2822;U-2823;U-2824;U-2832;U-2833;U-3333;U-3631;U-3695 | N | N | U English description not available. | — | — | — |
| 11970530 | 2041-10-25 | U U-3929 | N | N | U English description not available. | — | — | — |
| 11970530 | 2041-10-25 | U U-3931 | N | N | U English description not available. | — | — | — |
| 11970530 | 2041-10-25 | U U-3930 | N | N | U English description not available. | — | — | — |
| 11970530 | 2041-10-25 | ORANGE_BOOK U-3929;U-3930;U-3931 | 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 | 2014-12-19 | 2019-12-19 | English description not available. | Y | Y | 2019-12-19 | NP
Full coverage date: 2019-12-19
| Source |
| NP | 2017-08-17 | 2020-08-17 | English description not available. | Y | Y | 2020-08-17 | NP
Full coverage date: 2020-08-17
| Source |
| I-762 | 2018-01-12 | 2021-01-12 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| I-776 | 2018-12-19 | 2021-12-19 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| ODE-83 | 2014-12-19 | 2021-12-19 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| I-818 | 2019-12-27 | 2022-12-27 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| I-831 | 2020-05-08 | 2023-05-08 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| I-832 | 2020-05-19 | 2023-05-19 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| ODE-180 | 2017-08-17 | 2024-08-17 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| ODE-181 | 2017-08-17 | 2024-08-17 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| I-885 | 2022-03-11 | 2025-03-11 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| ODE-226 | 2018-12-19 | 2025-12-19 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| I-914 | 2023-05-31 | 2026-05-31 | English description not available. | N | N | — | — | Source |
| I-914 | 2023-05-31 | 2026-05-31 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| ODE-283 | 2019-12-27 | 2026-12-27 | English description not available. | N | N | — | — | Source |
| ODE-283 | 2019-12-27 | 2026-12-27 | English description not available. | N | N | — | NP
Full coverage date: —
| Source |
| ODE-306 | 2020-05-08 | 2027-05-08 | English description not available. | N | N | — | — | Source |
| ODE-306 | 2020-05-08 | 2027-05-08 | English description not available. | N | N | — | NP
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 (27)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-08-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-08-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-09-08 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2029-10-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2029-10-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2029-10-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2029-10-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2029-10-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2029-12-31 | FTO_TAIL | English description not available. | Source |
| PATENT | 2031-08-04 | FTO_TAIL | English description not available. | Source |
| PATENT | 2041-10-25 | FTO_TAIL | 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 | — | 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 | — | 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 | — | REGULATORY_SCOPE_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_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2027-09-08 | 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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2026-04-01 | Sandoz | SETTLEMENT Brand-level record; strength scope not established
|
Not disclosed | REVIEW | — |
| Entry date undisclosed | |||||