AGAMREE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US8334279 c1 DMD/vamorolone;PTE1791days from2029-05-28. Later suspension/FormI tails.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10857161 | 2029-05-28 | DP/U U-3747 | N | Y | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 10857161 | 2029-05-28 | ORANGE_BOOK U-3747 | N | Y | U English description not available. | — | — | — |
| 11833159 | 2029-05-28 | DP — | N | Y | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 11833159 | 2029-05-28 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 11690853 | 2033-03-07 | U U-3747 | N | N | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 11690853 | 2033-03-07 | ORANGE_BOOK U-3747 | N | N | U English description not available. | — | — | — |
| 8334279 | 2034-04-23 | U U-3747 | N | Y | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 8334279 | 2034-04-23 | ORANGE_BOOK U-3747 | N | Y | U English description not available. | — | — | — |
| 8334279 | 2034-04-23 | U U-3747 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 11471471 | 2040-03-17 | U U-3747 | N | N | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 11471471 | 2040-03-17 | ORANGE_BOOK U-3747 | N | N | U English description not available. | — | — | — |
| 12201639 | 2040-03-17 | DS/DP/U U-3747 | N | N | DP | B1C03P7 issued-claim review2026-10-15: DP | — | — | — |
| 12201639 | 2040-03-17 | ORANGE_BOOK U-3747 | N | N | DP English description not available. | — | — | — |
| 11382922 | 2040-07-16 | DS/DP — | N | N | DP | B1C03P7 issued-claim review2026-10-15: DP | — | — | — |
| 11382922 | 2040-07-16 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2023-10-26 | 2028-10-26 | English description not available. | Y | Y | 2028-10-26 | — | Source |
| NCE | 2023-10-26 | 2028-10-26 | English description not available. | Y | Y | 2028-10-26 | ODE-450
Full coverage date: 2028-10-26
| Source |
| ODE-450 | 2023-10-26 | 2030-10-26 | English description not available. | Y | Y | 2030-10-26 | — | Source |
| ODE-450 | 2023-10-26 | 2030-10-26 | English description not available. | Y | Y | 2030-10-26 | ODE-450
Full coverage date: 2030-10-26
| 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 |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US8334279 c1 DMD/vamorolone;PTE1791days from2029-05-28. Later suspension/FormI tails. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-04-23 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-04-23 | 2026-10-15 00:56:39 |
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.