NARCAN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2017 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. FDA legal approval withdrawal effective date, not notice publication.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US9480644 | 2035-03-16 | DP/U U-1903 | N | N | DP_DEVICE_U Independent device, formulation and overdose-treatment claims require approximately2mg naloxone, small-volume solution, isotonicity/preservative/stabilizer and pH conditions. The reviewed exact product is NARCAN2mg/0.1mL; no old-naloxone compound or unrestricted overdose-treatment anchor. | — | — | — |
| US9707226 | 2035-03-16 | DP/U U-1903 | N | N | U_DP Independent overdose method requires25-200microliter spray from pre-primed device, about2mg naloxone, isotonicity agent and benzalkonium chloride0.005-0.015%w/v. Other independent spray/device claims retain delivery/composition limits; do not import4mg claims or equate indication-name coverage with unrestricted DS-equivalent protection. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-12 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · 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 |
|---|---|---|---|---|---|---|---|
| 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 (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-03-16 | FTO_TAIL | Independent overdose method requires25-200microliter spray from pre-primed device, about2mg naloxone, isotonicity agent and benzalkonium chloride0.005-0.015%w/v. Other independent spray/device claims retain delivery/composition limits; do not import4mg claims or equate indication-name coverage with unrestricted DS-equivalent protection. | Source |
| PATENT | 2035-03-16 | FTO_TAIL | Independent device, formulation and overdose-treatment claims require approximately2mg naloxone, small-volume solution, isotonicity/preservative/stabilizer and pH conditions. The reviewed exact product is NARCAN2mg/0.1mL; no old-naloxone compound or unrestricted overdose-treatment anchor. | Source |
| REGULATORY_STATUS | 2023-02-10 | TERMINAL_STATUS | FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2017 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. FDA legal approval withdrawal effective date, not notice publication. | 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.
No litigation or settlement record currently linked to this product.