OZEMPIC
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DISQUALIFIED. Reference year: 2025. Anchor type: FDA_DISCONTINUATION. Patent anchor: 2031-12-05. Exclusivity anchor: 2022-12-05. Anchor date: not recorded. 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 |
|---|---|---|---|---|---|---|---|---|
| 10357616 | 2026-01-20 | DP — | N | N | DP English description not available. | — | — | — |
| 10357616 | 2026-01-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 10376652 | 2026-01-20 | DP — | N | N | DP English description not available. | — | — | — |
| 10376652 | 2026-01-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9108002 | 2026-01-20 | DP — | N | N | DP English description not available. | — | — | — |
| 9108002 | 2026-01-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9616180 | 2026-01-20 | DP — | N | N | DP English description not available. | — | — | — |
| 9616180 | 2026-01-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9861757 | 2026-01-20 | DP — | N | N | DP English description not available. | — | — | — |
| 9861757 | 2026-01-20 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8536122 | 2026-03-20 | DS/DP/U U-2202 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8536122 | 2026-03-20 | ORANGE_BOOK U-2202 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10220155 | 2026-07-17 | DP — | N | N | DP English description not available. | — | — | — |
| 10220155 | 2026-07-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11097063 | 2026-07-17 | DP — | N | N | DP English description not available. | — | — | — |
| 11097063 | 2026-07-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8920383 | 2026-07-17 | DP — | N | N | DP English description not available. | — | — | — |
| 8920383 | 2026-07-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9775953 | 2026-07-17 | DP — | N | N | DP English description not available. | — | — | — |
| 9775953 | 2026-07-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| RE46363 | 2026-08-03 | DP — | N | N | DP English description not available. | — | — | — |
| RE46363 | 2026-08-03 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9687611 | 2027-02-27 | DP — | N | N | DP English description not available. | — | — | — |
| 9687611 | 2027-02-27 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9457154 | 2027-09-29 | DP — | N | N | DP English description not available. | — | — | — |
| 9457154 | 2027-09-29 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8129343 | 2031-12-05 | DS/DP/U U-2202 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8129343 | 2031-12-05 | ORANGE_BOOK U-2202 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9132239 | 2032-02-01 | DP — | N | N | DP English description not available. | — | — | — |
| 9132239 | 2032-02-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 10335462 | 2033-06-21 | U U-2580 | N | N | U English description not available. | — | — | — |
| 10335462 | 2033-06-21 | ORANGE_BOOK U-2580 | 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 | 2017-12-05 | 2022-12-05 | English description not available. | Y | Y | 2022-12-05 | NCE
Full coverage date: 2022-12-05
| Source |
| I-822 | 2020-01-16 | 2023-01-16 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| I-961 | 2025-01-28 | 2028-01-28 | English description not available. | N | N | — | — | Source |
| I-961 | 2025-01-28 | 2028-01-28 | English description not available. | N | N | — | NCE
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 (20)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-01-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-01-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-01-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-01-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-01-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-03-20 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-07-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-07-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-07-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-07-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2026-08-03 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-02-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-09-29 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-12-05 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-02-01 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-06-21 | HISTORICAL_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 | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | English description not available. | 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.