RYANODEX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2021 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US9884044 | 2022-06-13 | DP/U U-1546 | N | N | DP_U Dantrolene/PVP stable colloidal suspension with volume, concentration and particle-size restrictions. Method claims inherit the PVP formulation; FDA RYANODEX excipient listing does not establish that every claimed formulation condition is met. | — | — | — |
| US8110225 | 2022-12-24 | DP — | N | N | DP Dry dantrolene sodium formulation reconstituting into a low-volume colloidal injection with polysorbate, sugar alcohol and particle/concentration requirements. | — | — | — |
| US8604072 | 2022-12-24 | DP — | N | N | U_DP Treating hyperthermia using the specified dantrolene colloidal injection recipe. RYANODEX also has prophylaxis of malignant hyperthermia; a treatment-only method is not the entire approved scope. | — | — | — |
| US8685460 | 2023-02-15 | U U-1546 | N | N | U_DP Treating heat stroke with a quantitatively specified dantrolene colloidal injection. Heat stroke is not RYANODEX approved malignant-hyperthermia treatment/prevention scope. | — | — | — |
| US7758890 | 2025-06-30 | DP — | N | N | DP Low-volume dantrolene colloidal injection with concentration, polysorbate, sorbitol/mannitol and particle-size limitations; no standalone dantrolene compound. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE | 2014-07-22 | 2021-07-22 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; ODE and ODE-69 are aliases. The FDA protected-indication field explicitly includes BOTH treatment with supportive measures AND prevention of malignant hyperthermia in high-risk patients. The narrower designation title is not substituted for the actual protected scope. Heatstroke and other unapproved designations are not imported. | Y | Y | 2021-07-22 | 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 |
|---|---|---|---|---|---|---|---|
| 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 | 2022-06-13 | FTO_TAIL | Dantrolene/PVP stable colloidal suspension with volume, concentration and particle-size restrictions. Method claims inherit the PVP formulation; FDA RYANODEX excipient listing does not establish that every claimed formulation condition is met. | Source |
| PATENT | 2022-12-24 | FTO_TAIL | Dry dantrolene sodium formulation reconstituting into a low-volume colloidal injection with polysorbate, sugar alcohol and particle/concentration requirements. | Source |
| PATENT | 2022-12-24 | FTO_TAIL | Treating hyperthermia using the specified dantrolene colloidal injection recipe. RYANODEX also has prophylaxis of malignant hyperthermia; a treatment-only method is not the entire approved scope. | Source |
| PATENT | 2023-02-15 | FTO_TAIL | Treating heat stroke with a quantitatively specified dantrolene colloidal injection. Heat stroke is not RYANODEX approved malignant-hyperthermia treatment/prevention scope. | Source |
| PATENT | 2025-06-30 | FTO_TAIL | Low-volume dantrolene colloidal injection with concentration, polysorbate, sorbitol/mannitol and particle-size limitations; no standalone dantrolene compound. | Source |
| REGULATORY_EXCLUSIVITY | 2021-07-22 | CANONICAL_ANCHOR | FULL_EXACT_PRODUCT_APPROVED_SCOPE; ODE and ODE-69 are aliases. The FDA protected-indication field explicitly includes BOTH treatment with supportive measures AND prevention of malignant hyperthermia in high-risk patients. The narrower designation title is not substituted for the actual protected scope. Heatstroke and other unapproved designations are not imported. | Source |
| REGULATORY_STATUS | 2021-07-22 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2021 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. | 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.