SPRAVATO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US11883526 claims1-33: missed maintenance session, worsening symptoms and return to higher frequency are mandatory limitations. U, not DS-equivalent;2040-02-18 tail retained. Existing2035 anchor retained; anchor-type label inherited, not a new TRUE_DS determination.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9592207 | 2027-03-20 | U U-4112 | — | — | — | — | — | — |
| 9592207 | 2027-03-20 | U U-2502 | — | — | — | — | — | — |
| 8785500 | 2033-03-05 | U U-2502 | — | — | — | — | — | — |
| 8785500 | 2033-03-05 | U U-4112 | — | — | — | — | — | — |
| 11446260 | 2034-03-14 | U U-3445 | — | — | — | — | — | — |
| 11446260 | 2034-03-14 | U U-3446 | — | — | — | — | — | — |
| 11446260 | 2034-03-14 | U U-3444 | — | — | — | — | — | — |
| 11446260 | 2034-03-14 | U U-4119 | — | — | — | — | — | — |
| 11446260 | 2034-03-14 | U U-4118 | — | — | — | — | — | — |
| 10869844 | 2035-09-10 | U U-3036 | — | — | — | — | — | — |
| 10869844 | 2035-09-10 | U U-3035 | — | — | — | — | — | — |
| 10869844 | 2035-09-10 | U U-3034 | — | — | — | — | — | — |
| 10869844 | 2035-09-10 | U U-4113 | — | — | — | — | — | — |
| 10869844 | 2035-09-10 | U U-4114 | — | — | — | — | — | — |
| 11173134 | 2035-09-10 | U U-3536 | — | — | — | — | — | — |
| 11173134 | 2035-09-10 | U U-4115 | — | — | — | — | — | — |
| 11173134 | 2035-09-10 | U U-3257 | — | — | — | — | — | — |
| 11311500 | 2035-09-10 | U U-4116 | — | — | — | — | — | — |
| 11311500 | 2035-09-10 | U U-3034 | — | — | — | — | — | — |
| 11311500 | 2035-09-10 | U U-3035 | — | — | — | — | — | — |
| 11311500 | 2035-09-10 | U U-4117 | — | — | — | — | — | — |
| 11311500 | 2035-09-10 | U U-3036 | — | — | — | — | — | — |
| 11883526 | 2040-02-18 | U U-3813 | — | — | — | — | — | — |
| 11883526 | 2040-02-18 | U U-4120 | — | — | — | — | — | — |
| 11883526 | 2040-02-18 | U U-3812 | — | — | — | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-959 | — | 2028-01-17 | — | — | — | — | Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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 (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| FULL_YEAR_RECHECK | — | ANCHOR_AND_TAIL | US11883526 claims1-33: missed maintenance session, worsening symptoms and return to higher frequency are mandatory limitations. U, not DS-equivalent;2040-02-18 tail retained. Existing2035 anchor retained; anchor-type label inherited, not a new TRUE_DS determination. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2035 | DEEP_REVIEW | FINAL | 2035-09-10 | 2026-10-17 22:44:36 |
| N | 2035 | DEEP_REVIEW | FINAL | 2035-09-10 | 2026-10-16 20:34:13 |
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.