EMBEDA
Patent Legal Status & Termination ↓ · Patent Litigation & Settlement History ↓
Current GenericRadar decision
EMBEDA: NC full combination exclusivity ends 2012-08-13; S-016 abuse-deterrent label-change tail ends 2017-10-17, not full-product anchor. Later non-DS DP/U patents remain. 2012 DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US8685443 | 2025-07-03 | U U-1508 | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US8685444 | 2025-07-03 | DP — | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US7682633 | 2027-06-19 | U U-1510 | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US7682634 | 2027-06-19 | DP — | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US8158156 | 2027-06-19 | U U-1510 | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US8846104 | 2027-06-19 | DP — | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US8877247 | 2027-06-19 | DP — | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| 7815934 | 2027-12-12 | DP — | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
| US8623418 | 2029-11-07 | U U-1640 | N | N | FORMULATION_OR_USE TRUE_DS=N; DS-equivalent=N provisional. Legal expiry and termination are separate. | — | — | — |
Patent Legal Status & Termination
Country-specific legal status and termination history recorded for patents linked to this product. A termination event does not establish the current end of protection without checking restoration and legal effect. Unknown values are not treated as confirmed absence.
| Patent | Legal status | Termination cause | Termination effective date | Restoration status | Restoration date | Actual protection end | Verified / reviewed | Source |
|---|---|---|---|---|---|---|---|---|
| 7815934 | — | MAINTENANCE_FEE_NONPAYMENT | 2022-10-19 | UNVERIFIED | — | — Not confirmed as final |
Not verified | Source |
| US7682633 | — | MAINTENANCE_FEE_NONPAYMENT | 2022-03-23 | UNVERIFIED | — | — Not confirmed as final |
Not verified | Source |
| US8158156 | — | MAINTENANCE_FEE_NONPAYMENT | 2024-04-17 | UNVERIFIED | — | — Not confirmed as final |
Not verified | Source |
| US8623418 | — | MAINTENANCE_FEE_NONPAYMENT | 2022-01-07 | UNVERIFIED | — | — Not confirmed as final |
Not verified | Source |
| US8846104 | — | MAINTENANCE_FEE_NONPAYMENT | 2022-09-30 | UNVERIFIED | — | — Not confirmed as final |
Not verified | Source |
| US8877247 | — | MAINTENANCE_FEE_NONPAYMENT | 2022-11-04 | UNVERIFIED | — | — Not confirmed as final |
Not verified | Source |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NC | 2009-08-13 | 2012-08-13 | Original new fixed-combination 3-year exclusivity: morphine sulfate/naltrexone hydrochloride | Y | Y | — | — | Source |
| S-016 | 2014-10-17 | 2017-10-17 | Supplement S-016: abuse-deterrent labeling/change-specific 3-year exclusivity. FDA states protection is tied to the combination of active moieties, but does not establish that all original approved uses are blocked. | N | N | — | — | Source |
2026-10-24 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: PARTIAL_HISTORY_RECOVERED
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. | ||||||
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.