Product profile · United States
EMPAVELI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2033. Anchor type: PATENT. Patent anchor: 2033-11-15. Exclusivity anchor: 2026-05-14. Anchor date: 2033-11-15. 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 |
|---|---|---|---|---|---|---|---|---|
| 9169307 | 2027-11-18 | DS/U U-4244 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9169307 | 2027-11-18 | DS/U U-3123 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9169307 | 2027-11-18 | ORANGE_BOOK U-3123;U-4244 | Y | N | TRUE_DS English description not available. | — | — | — |
| 7888323 | 2027-12-04 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7888323 | 2027-12-04 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7989589 | 2027-12-04 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7989589 | 2027-12-04 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11661441 | 2033-01-13 | DS/U U-4242 | N | Y | U English description not available. | — | — | — |
| 11661441 | 2033-01-13 | DS/U U-3124 | N | Y | U English description not available. | — | — | — |
| 11661441 | 2033-01-13 | ORANGE_BOOK U-3124;U-4242 | N | Y | U English description not available. | — | — | — |
| 10125171 | 2033-08-02 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10125171 | 2033-08-02 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10035822 | 2033-11-15 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10035822 | 2033-11-15 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10875893 | 2033-11-15 | DS/U U-4242 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10875893 | 2033-11-15 | DS/U U-3124 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10875893 | 2033-11-15 | ORANGE_BOOK U-3124;U-4242 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11292815 | 2033-11-15 | DS/DP/U U-4242 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11292815 | 2033-11-15 | DS/DP/U U-4243 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11292815 | 2033-11-15 | DS/DP/U U-3124 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11292815 | 2033-11-15 | DS/DP/U U-3354 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11292815 | 2033-11-15 | ORANGE_BOOK U-3124;U-3354;U-4242;U-4243 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11040107 | 2038-04-09 | DP/U U-4241 | N | N | U English description not available. | — | — | — |
| 11040107 | 2038-04-09 | DP/U U-3173 | N | N | U English description not available. | — | — | — |
| 11040107 | 2038-04-09 | DP/U U-3174 | N | N | U English description not available. | — | — | — |
| 11040107 | 2038-04-09 | DP/U U-3172 | N | N | U English description not available. | — | — | — |
| 11040107 | 2038-04-09 | ORANGE_BOOK U-3172;U-3173;U-3174;U-4241 | N | N | U English description not available. | — | — | — |
| 11844841 | 2038-12-09 | DP/U U-3173 | N | N | U English description not available. | — | — | — |
| 11844841 | 2038-12-09 | DP/U U-3172 | N | N | U English description not available. | — | — | — |
| 11844841 | 2038-12-09 | DP/U U-4241 | N | N | U English description not available. | — | — | — |
| 11844841 | 2038-12-09 | DP/U U-3174 | N | N | U English description not available. | — | — | — |
| 11844841 | 2038-12-09 | ORANGE_BOOK U-3172;U-3173;U-3174;U-4241 | N | N | U English description not available. | — | — | — |
| 12290566 | 2038-12-14 | DP/U U-4175 | N | N | DP English description not available. | — | — | — |
| 12290566 | 2038-12-14 | DP/U U-4174 | N | N | DP English description not available. | — | — | — |
| 12290566 | 2038-12-14 | DP/U U-4238 | N | N | DP English description not available. | — | — | — |
| 12290566 | 2038-12-14 | DP/U U-4240 | N | N | DP English description not available. | — | — | — |
| 12290566 | 2038-12-14 | DP/U U-4239 | N | N | DP English description not available. | — | — | — |
| 12290566 | 2038-12-14 | ORANGE_BOOK U-4174;U-4175;U-4238;U-4239;U-4240 | N | N | DP English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-288 | 2023-02-08 | 2026-02-08 | English description not available. | N | N | — | — | Source |
| M-288 | 2023-02-08 | 2026-02-08 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| NCE | 2021-05-14 | 2026-05-14 | English description not available. | Y | Y | 2026-05-14 | — | Source |
| NCE | 2021-05-14 | 2026-05-14 | English description not available. | Y | Y | 2026-05-14 | NCE
Full coverage date: 2026-05-14
| Source |
| ODE-351 | 2021-05-14 | 2028-05-14 | English description not available. | N | N | — | — | Source |
| ODE-351 | 2021-05-14 | 2028-05-14 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| I-972 | 2025-07-28 | 2028-07-28 | English description not available. | N | N | — | — | Source |
| I-972 | 2025-07-28 | 2028-07-28 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| ODE-533 | 2025-07-28 | 2032-07-28 | English description not available. | N | N | — | — | Source |
| ODE-533 | 2025-07-28 | 2032-07-28 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| ODE-539 | 2025-07-28 | 2032-07-28 | English description not available. | N | N | — | — | Source |
| ODE-539 | 2025-07-28 | 2032-07-28 | 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 (18)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-11-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-12-04 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-12-04 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-08-02 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-11-15 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2033-11-15 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2033-11-15 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2038-04-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-12-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-12-14 | FTO_TAIL | 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 | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2033-11-15 | 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.