Product profile · United States
NATROBA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Latest qualifying historical full-scope anchor 2016-01-18; 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 |
|---|---|---|---|---|---|---|---|---|
| US5496931 | 2013-03-05 | DS — | Y | N | TRUE_DS Claim 1 compound formula includes A83543A and A83543D substituent combinations; these are spinosad components. The description component table maps A and D to the claimed combinations. Molecular coverage is not limited to head-lice use. | — | — | — |
| US6342482 | 2019-06-22 | DP — | N | N | DP Claims require spinosyn in a conditioner formulation with conditioning agent and water. Not unrestricted substance coverage. | — | — | — |
| US7030095 | 2021-07-02 | DP — | N | N | DP Head-lice treatment claims require a specified spinosad solution with solvent/excipient restrictions. Not unrestricted substance coverage; the current scabies indication is outside the claimed head-lice use. | — | — | — |
| US6063771 | 2023-07-25 | DP — | N | N | DP Head-lice shampoo requires spinosyn, synthetic surfactant, amide and water in specified ranges. Not unrestricted substance or all-current-use coverage. Latest FDA-listed end 2023-07-25 replaces earlier 2019-06-22 in the retained history. | — | — | — |
| 9895388 | 2033-11-25 | U U-3365 | N | N | U | — | — | — |
| 9895388 | 2033-11-25 | U U-3365 | N | N | U Independent claim 1 is treatment of human scabies using a specified spinosyn mixture. NATROBA also treats head lice. Scabies-only U does not cover all approved indications. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2011-01-18 | 2016-01-18 | 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 | 2016-01-18 | Source | |
| M-152 | — | 2017-11-30 | Pediatric head-lice safety information for subjects aged 6 months to 4 years. Established older-patient head-lice use is not covered. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | Source | |
| I-858 | 2021-04-28 | 2024-04-28 | Scabies infestations in adult/pediatric patients aged 4 years or older. Head-lice treatment is outside this indication. Scope version: approved uses at grant; later expansions are assessed separately. | N | N | — | 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 |
|---|---|---|---|---|---|---|---|
| 022408 / 001 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | ParaPRO LLC | 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 |
|---|---|---|---|---|---|---|
| 022408 / 001 | ParaPRO LLC | 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 (9)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2013-03-05 | CANONICAL_ANCHOR | Claim 1 compound formula includes A83543A and A83543D substituent combinations; these are spinosad components. The description component table maps A and D to the claimed combinations. Molecular coverage is not limited to head-lice use. | Source |
| PATENT | 2019-06-22 | FTO_TAIL | Claims require spinosyn in a conditioner formulation with conditioning agent and water. Not unrestricted substance coverage. | Source |
| PATENT | 2021-07-02 | FTO_TAIL | Head-lice treatment claims require a specified spinosad solution with solvent/excipient restrictions. Not unrestricted substance coverage; the current scabies indication is outside the claimed head-lice use. | Source |
| PATENT | 2023-07-25 | FTO_TAIL | Head-lice shampoo requires spinosyn, synthetic surfactant, amide and water in specified ranges. Not unrestricted substance or all-current-use coverage. Latest FDA-listed end 2023-07-25 replaces earlier 2019-06-22 in the retained history. | Source |
| PATENT | 2033-11-25 | FTO_TAIL | Independent claim 1 is treatment of human scabies using a specified spinosyn mixture. NATROBA also treats head lice. Scabies-only U does not cover all approved indications. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Scabies infestations in adult/pediatric patients aged 4 years or older. Head-lice treatment is outside this indication. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Pediatric head-lice safety information for subjects aged 6 months to 4 years. Established older-patient head-lice use is not covered. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_EXCLUSIVITY | 2016-01-18 | 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 | 2016-01-18 | DECISION_BASIS | Latest qualifying historical full-scope anchor 2016-01-18; 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.