EXPAREL
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
ANDA 214348/002 Final 2024-07-01; FDA RLD brand source candidate. Earliest exact-product Final ANDA and explicit product correspondence still require independent confirmation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11033495 | 2041-01-22 | DP/U U-3182 | — | — | — | — | — | — |
| 11179336 | 2041-01-22 | DP/U U-3250 | — | — | — | — | — | — |
| 11278494 | 2041-01-22 | DP/U U-3250 | — | — | — | — | — | — |
| 11304904 | 2041-01-22 | DP/U U-3346 | — | — | — | — | — | — |
| 11311486 | 2041-01-22 | DP/U U-3250 | — | — | — | — | — | — |
| 11357727 | 2041-01-22 | DP/U U-3380 | — | — | — | — | — | — |
| 11426348 | 2041-01-22 | DP/U U-3380 | — | — | — | — | — | — |
| 11452691 | 2041-01-22 | DP/U U-3439 | — | — | — | — | — | — |
| 11819574 | 2041-01-22 | DP/U U-3250 | — | — | — | — | — | — |
| 11819575 | 2041-01-22 | DP/U U-3250 | — | — | — | — | — | — |
| 11925706 | 2041-01-22 | DP/U U-3380 | — | — | — | — | — | — |
| 12144890 | 2041-01-22 | DP/U U-4033 | — | — | — | — | — | — |
| 12151024 | 2041-01-22 | DP/U U-4037 | — | — | — | — | — | — |
| 12296047 | 2041-01-22 | DP/U U-4184 | — | — | — | — | — | — |
| 11931459 | 2042-03-17 | U U-3840 | — | — | — | — | — | — |
| 11931459 | 2042-03-17 | U U-3839 | — | — | — | — | — | — |
| 11918565 | 2043-02-02 | U U-3841 | — | — | — | — | — | — |
| 12226610 | 2043-02-02 | U U-4148 | — | — | — | — | — | — |
| 12226610 | 2043-02-02 | U U-4149 | — | — | — | — | — | — |
| 12226610 | 2043-02-02 | U U-4150 | — | — | — | — | — | — |
| 12156940 | 2044-07-02 | DP — | — | — | — | — | — | — |
| 12251468 | 2044-07-02 | DP/U U-4152 | — | — | — | — | — | — |
| 12318483 | 2044-07-02 | U U-4152 | — | — | — | — | — | — |
| 12370142 | 2044-07-02 | DP/U U-4152 | — | — | — | — | — | — |
| 12728094 | 2044-07-02 | DP;U U-4152 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12728095 | 2044-07-02 | DP;U U-4152 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-929 | — | 2026-11-09 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 214348 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2024-07-01 | — | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 1 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 |
|---|---|---|---|---|---|---|
| 214348 / 002 | JIANGSU HENGRUI PHARMACEUTICALS CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-07-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2025-04-07 | eVenus / Fresenius | SETTLEMENT Brand-level record; strength scope not established
|
2030 | REVIEW | — |
| Limited-quantity license; exact terms and counterparty split pending | |||||