KLOXXADO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No qualifying substance, full-scope use patent or full-scope exclusivity anchor was adopted from the checked sources. Deep Review uses the FDA approval year.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10722510 | 2034-08-26 | HISTORICAL_REFERENCE_NOT_EXACT_OB U-3110 | N | N | DP / FORMULATION_DEPENDENT_U Naloxone 8-12 wt% with ethanol, propylene glycol and EDTA. A dose in mg/0.1 mL is not directly converted to wt%. Formulation-limited claims are not promoted to substance or full-scope use anchors. | — | — | — |
| 10973814 | 2034-08-26 | HISTORICAL_REFERENCE_NOT_EXACT_OB U-3110 | N | N | DP / FORMULATION_DEPENDENT_U Naloxone 7.5 wt% formulation; opioid dependence and overdose methods depend on composition claim 1. Not an unrestricted substance or full-scope use anchor. | — | — | — |
| 11135155 | 2034-08-26 | HISTORICAL_REFERENCE_NOT_EXACT_OB — | N | N | DP / FORMULATION_DEPENDENT_U Naloxone 5-16 wt% with a chelating agent. The 4 mg/0.1 mL product is distinguished from the 8 mg product. Not a substance or unrestricted full-scope use anchor. | — | — | — |
| 11617713 | 2034-08-26 | HISTORICAL_REFERENCE_NOT_EXACT_OB U-3110 | N | N | DP / FORMULATION_DEPENDENT_U Formulation specifying naloxone 4-10 wt%, ethanol 20-50 wt%, propylene glycol 5-10 wt%, and EDTA. Not a substance or unrestricted full-scope use anchor. | — | — | — |
| 11628139 | 2034-08-26 | HISTORICAL_REFERENCE_NOT_EXACT_OB U-3110 | N | N | DP / FORMULATION_DEPENDENT_U Naloxone as the sole active at 2-10 wt%, with specified ethanol, propylene glycol and EDTA. Potential formulation correspondence to 4 mg does not establish every quantitative claim element. Not a substance or DS-equivalent anchor. | — | — | — |
| 11975096 | 2034-08-26 | HISTORICAL_REFERENCE_NOT_EXACT_OB — | N | N | DP / FORMULATION_DEPENDENT_U Nasal formulation specifying naloxone 5-15 wt%, chelating agent, ethanol and propylene glycol. Not an unrestricted substance or full-scope use anchor. | — | — | — |
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. | ||||||||
2026-10-13 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · Historical coverage: ANNUALS_AND_MONTHLY_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 (7)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2034-08-26 | FTO_TAIL | Naloxone 8-12 wt% with ethanol, propylene glycol and EDTA. A dose in mg/0.1 mL is not directly converted to wt%. Formulation-limited claims are not promoted to substance or full-scope use anchors. | Source |
| PATENT | 2034-08-26 | FTO_TAIL | Naloxone 7.5 wt% formulation; opioid dependence and overdose methods depend on composition claim 1. Not an unrestricted substance or full-scope use anchor. | Source |
| PATENT | 2034-08-26 | FTO_TAIL | Naloxone 5-16 wt% with a chelating agent. The 4 mg/0.1 mL product is distinguished from the 8 mg product. Not a substance or unrestricted full-scope use anchor. | Source |
| PATENT | 2034-08-26 | FTO_TAIL | Formulation specifying naloxone 4-10 wt%, ethanol 20-50 wt%, propylene glycol 5-10 wt%, and EDTA. Not a substance or unrestricted full-scope use anchor. | Source |
| PATENT | 2034-08-26 | FTO_TAIL | Naloxone as the sole active at 2-10 wt%, with specified ethanol, propylene glycol and EDTA. Potential formulation correspondence to 4 mg does not establish every quantitative claim element. Not a substance or DS-equivalent anchor. | Source |
| PATENT | 2034-08-26 | FTO_TAIL | Nasal formulation specifying naloxone 5-15 wt%, chelating agent, ethanol and propylene glycol. Not an unrestricted substance or full-scope use anchor. | Source |
| REGULATORY_STATUS | 2025-08-25 | CANONICAL_DECISION | No qualifying substance, full-scope use patent or full-scope exclusivity anchor was adopted from the checked sources. Deep Review uses the FDA approval year. | 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.