Product profile · United States
GOPRELTO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Latest qualifying historical full-scope anchor 2022-12-14; later patent/regulatory rights remain, so DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10016407 | 2037-02-07 | U U-2329 | N | N | U | — | — | — |
| 10016407 | 2037-02-07 | U U-2329 | N | N | U Independent claim requires hepatic or renal impairment. Patient-subgroup U, not whole-scope coverage. | — | — | — |
| 10149843 | 2037-02-07 | U U-2479 | N | N | U | — | — | — |
| 10149843 | 2037-02-07 | U U-2478 | N | N | U | — | — | — |
| 10149843 | 2037-02-07 | U U-2478,U-2479 | N | N | U Independent claim is a diagnostic-procedure method with specified composition and absorptivity. Approved indications also include surgery; no full-scope promotion. | — | — | — |
| 10231961 | 2037-02-07 | DP — | N | N | DP | — | — | — |
| 10231961 | 2037-02-07 | DP — | N | N | DP Specific cocaine/citrate/benzoate formulation and amber-bottle closure/stability conditions. DP. | — | — | — |
| 10413505 | 2037-02-07 | U U-2479 | N | N | U | — | — | — |
| 10413505 | 2037-02-07 | U U-2479 | N | N | U Independent claim limits procedures, naturally derived cocaine, pledgets and PK/analgesia outcomes. Does not cover every approved diagnostic/surgical use and regimen. | — | — | — |
| 10420760 | 2037-02-07 | U U-2478 | N | N | U | — | — | — |
| 10420760 | 2037-02-07 | U U-2478 | N | N | U Independent claim requires renal-function testing and a restricted eGFR range. Patient-subgroup U. | — | — | — |
| 10857095 | 2037-02-07 | U U-3014 | N | N | U | — | — | — |
| 10857095 | 2037-02-07 | U U-3014 | N | N | U Use claims include multiple cocaine/metabolite PK, impurity and pledget-retention limits. All-indication language alone is insufficient to establish unavoidable product-wide coverage. | — | — | — |
| 10894012 | 2037-02-07 | U U-3014 | N | N | U | — | — | — |
| 10894012 | 2037-02-07 | U U-3014 | N | N | U Broad diagnostic/surgical use is claimed with four pledgets, quantitative excipients, AUC and analgesia restrictions. GOPRELTO has a weight-related maximum dose and NUMBRINO permits 40-160 mg. No proof all approved regimens inevitably satisfy every limitation; retain U. | — | — | — |
| 10933060 | 2037-02-07 | U U-3014 | N | N | U | — | — | — |
| 10933060 | 2037-02-07 | U U-3014 | N | N | U Use claims require four absorbent articles, quantitative excipient ranges and absorptivity. No evidence all approved regimens and equivalent formulations inevitably satisfy the limitations. | — | — | — |
| 10973811 | 2037-02-07 | U U-2226 | N | N | U | — | — | — |
| 10973811 | 2037-02-07 | U U-2226 | N | N | U Independent claim requires renal impairment. Patient-subgroup U. | — | — | — |
| 10987347 | 2037-02-07 | U U-2225 | N | N | U | — | — | — |
| 10987347 | 2037-02-07 | U U-2225 | N | N | U Independent claims require Child-Pugh score testing and specific hepatic classes. Patient-subgroup U. | — | — | — |
| 11040032 | 2037-02-07 | DP — | N | N | DP | — | — | — |
| 11040032 | 2037-02-07 | DP — | N | N | DP Specific cocaine/citrate/benzoic-acid composition, pH and storage-stability requirements. DP. | — | — | — |
| 9867815 | 2037-02-07 | U U-2226 | N | N | U | — | — | — |
| 9867815 | 2037-02-07 | U U-2227 | N | N | U | — | — | — |
| 9867815 | 2037-02-07 | U U-2225 | N | N | U | — | — | — |
| 9867815 | 2037-02-07 | U U-2225,U-2226,U-2227 | N | N | U Independent claim requires hepatic impairment and specific composition/administration conditions. Patient-subgroup U. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2017-12-14 | 2022-12-14 | Active-moiety-wide regulatory exclusivity. NUMBRINO shares the cocaine NCE barrier originating with GOPRELTO; its listed NCE end is not a fresh five-year term from its 2020 approval. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2022-12-14 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 209963 / 001 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Genus Lifesciences Inc. | Y | 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 1 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 209963 / 001 | Genus Lifesciences Inc. | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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 (14)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2037-02-07 | FTO_TAIL | Specific cocaine/citrate/benzoic-acid composition, pH and storage-stability requirements. DP. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Specific cocaine/citrate/benzoate formulation and amber-bottle closure/stability conditions. DP. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claims require Child-Pugh score testing and specific hepatic classes. Patient-subgroup U. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claim requires hepatic or renal impairment. Patient-subgroup U, not whole-scope coverage. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claim is a diagnostic-procedure method with specified composition and absorptivity. Approved indications also include surgery; no full-scope promotion. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claim requires renal-function testing and a restricted eGFR range. Patient-subgroup U. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Use claims require four absorbent articles, quantitative excipient ranges and absorptivity. No evidence all approved regimens and equivalent formulations inevitably satisfy the limitations. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Use claims include multiple cocaine/metabolite PK, impurity and pledget-retention limits. All-indication language alone is insufficient to establish unavoidable product-wide coverage. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claim requires renal impairment. Patient-subgroup U. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claim limits procedures, naturally derived cocaine, pledgets and PK/analgesia outcomes. Does not cover every approved diagnostic/surgical use and regimen. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Broad diagnostic/surgical use is claimed with four pledgets, quantitative excipients, AUC and analgesia restrictions. GOPRELTO has a weight-related maximum dose and NUMBRINO permits 40-160 mg. No proof all approved regimens inevitably satisfy every limitation; retain U. | Source |
| PATENT | 2037-02-07 | FTO_TAIL | Independent claim requires hepatic impairment and specific composition/administration conditions. Patient-subgroup U. | Source |
| REGULATORY_EXCLUSIVITY | 2022-12-14 | CANONICAL_ANCHOR | Active-moiety-wide regulatory exclusivity. NUMBRINO shares the cocaine NCE barrier originating with GOPRELTO; its listed NCE end is not a fresh five-year term from its 2020 approval. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_STATUS | 2022-12-14 | DECISION_BASIS | Latest qualifying historical full-scope anchor 2022-12-14; later patent/regulatory rights remain, so DEEP_REVIEW. | 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.