Product profile · United States
SOFDRA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2029. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: 2027-11-13. Exclusivity anchor: 2029-06-20. Anchor date: 2029-06-20. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8147809 | 2027-03-26 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8147809 | 2027-03-26 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8628759 | 2027-11-13 | U U-2398 | N | Y | U English description not available. | — | — | — |
| 8628759 | 2027-11-13 | ORANGE_BOOK U-2398 | N | Y | U English description not available. | — | — | — |
| 8628759 | 2027-11-13 | U U-2398 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 10383846 | 2034-03-14 | U U-2398 | N | N | U English description not available. | — | — | — |
| 10383846 | 2034-03-14 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 9220707 | 2034-03-14 | U U-2398 | N | N | U English description not available. | — | — | — |
| 9220707 | 2034-03-14 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 9492429 | 2034-03-14 | DP/U U-2398 | N | N | U English description not available. | — | — | — |
| 9492429 | 2034-03-14 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 9895350 | 2034-03-14 | U U-2398 | N | N | U English description not available. | — | — | — |
| 9895350 | 2034-03-14 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 10947192 | 2034-05-22 | U U-2398 | N | N | U English description not available. | — | — | — |
| 10947192 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 10952990 | 2034-05-22 | U U-2398 | N | N | U English description not available. | — | — | — |
| 10952990 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 10959983 | 2034-05-22 | U U-2398 | N | N | U English description not available. | — | — | — |
| 10959983 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 10961191 | 2034-05-22 | U U-2398 | N | N | U English description not available. | — | — | — |
| 10961191 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | U English description not available. | — | — | — |
| 11026919 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 11026919 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 11034652 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 11034652 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 11052067 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 11052067 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 11084788 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 11084788 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 12156865 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 12156865 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 12357609 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 12357609 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 12398102 | 2034-05-22 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 12398102 | 2034-05-22 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 11123325 | 2037-07-20 | DP/U U-2398 | N | N | DP English description not available. | — | — | — |
| 11123325 | 2037-07-20 | ORANGE_BOOK U-2398 | N | N | DP English description not available. | — | — | — |
| 11566000 | 2040-05-22 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 11566000 | 2040-05-22 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11584715 | 2040-05-22 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 11584715 | 2040-05-22 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12703682 | 2040-05-22 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 12703682 | 2040-05-22 | 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 | 2024-06-18 | 2029-06-20 | English description not available. | Y | Y | 2029-06-20 | — | Source |
| NCE | 2024-06-18 | 2029-06-20 | English description not available. | Y | Y | 2029-06-20 | NCE
Full coverage date: 2029-06-20
| 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 (23)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-03-26 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-11-13 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2034-03-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-03-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-03-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-03-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2037-07-20 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-22 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-05-22 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | CANONICAL_ANCHOR | English description not available. | Source |
| REGULATORY_STATUS | 2029-06-20 | CANONICAL_DECISION | English description not available. | Source |
Independent legal-event information
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.