Product profile · United States
ROZLYTREK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2035. Anchor type: PATENT. Patent anchor: 2035-02-17. Exclusivity anchor: 2026-08-15. Anchor date: 2035-02-17. 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 |
|---|---|---|---|---|---|---|---|---|
| 8673893 | 2028-07-08 | U U-2617 | N | N | U English description not available. | — | — | — |
| 8673893 | 2028-07-08 | U U-2618 | N | N | U English description not available. | — | — | — |
| 8673893 | 2028-07-08 | ORANGE_BOOK U-2617;U-2618 | N | N | U English description not available. | — | — | — |
| 9029356 | 2028-07-08 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9029356 | 2028-07-08 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9085558 | 2028-07-08 | DP — | N | N | DP English description not available. | — | — | — |
| 9085558 | 2028-07-08 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9255087 | 2028-07-08 | U U-2618 | N | N | U English description not available. | — | — | — |
| 9255087 | 2028-07-08 | U U-2617 | N | N | U English description not available. | — | — | — |
| 9255087 | 2028-07-08 | ORANGE_BOOK U-2617;U-2618 | N | N | U English description not available. | — | — | — |
| 9616059 | 2028-07-08 | U U-2618 | N | N | U English description not available. | — | — | — |
| 9616059 | 2028-07-08 | ORANGE_BOOK U-2618 | N | N | U English description not available. | — | — | — |
| 8299057 | 2032-03-10 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8299057 | 2032-03-10 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9085565 | 2033-05-22 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 9085565 | 2033-05-22 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9649306 | 2033-05-22 | U U-2618 | N | N | U English description not available. | — | — | — |
| 9649306 | 2033-05-22 | U U-2617 | N | N | U English description not available. | — | — | — |
| 9649306 | 2033-05-22 | ORANGE_BOOK U-2617;U-2618 | N | N | U English description not available. | — | — | — |
| 10231965 | 2035-02-17 | U U-2618 | N | Y | U English description not available. | — | — | — |
| 10231965 | 2035-02-17 | U U-2617 | N | Y | U English description not available. | — | — | — |
| 10231965 | 2035-02-17 | ORANGE_BOOK U-2617;U-2618 | N | Y | U English description not available. | — | — | — |
| 10561651 | 2035-02-19 | U U-2745 | N | N | U English description not available. | — | — | — |
| 10561651 | 2035-02-19 | ORANGE_BOOK U-2745 | N | N | U English description not available. | — | — | — |
| 10738037 | 2037-05-18 | DS/DP/U U-2946 | N | N | DP English description not available. | — | — | — |
| 10738037 | 2037-05-18 | ORANGE_BOOK U-2946 | N | N | DP English description not available. | — | — | — |
| 11091469 | 2037-05-18 | U U-2618 | N | N | U English description not available. | — | — | — |
| 11091469 | 2037-05-18 | U U-2617 | N | N | U English description not available. | — | — | — |
| 11091469 | 2037-05-18 | ORANGE_BOOK U-2617;U-2618 | N | N | U English description not available. | — | — | — |
| 10398693 | 2038-07-18 | DP — | N | N | DP English description not available. | — | — | — |
| 10398693 | 2038-07-18 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11253515 | 2038-07-18 | DP — | N | N | DP English description not available. | — | — | — |
| 11253515 | 2038-07-18 | 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 | 2019-08-15 | 2024-08-15 | English description not available. | Y | Y | 2024-08-15 | ODE-265 + ODE-313 + ODE-448
Full coverage date: 2024-08-15
| Source |
| ODE-265 | 2019-08-15 | 2026-08-15 | English description not available. | N | N | — | — | Source |
| ODE-265 | 2019-08-15 | 2026-08-15 | English description not available. | N | N | — | ODE-265 + ODE-313 + ODE-448
Full coverage date: —
| Source |
| ODE-313 | 2019-08-15 | 2026-08-15 | English description not available. | N | N | — | — | Source |
| ODE-313 | 2019-08-15 | 2026-08-15 | English description not available. | N | N | — | ODE-265 + ODE-313 + ODE-448
Full coverage date: —
| Source |
| NPP | 2023-10-20 | 2026-10-20 | English description not available. | N | N | — | — | Source |
| NPP | 2023-10-20 | 2026-10-20 | English description not available. | N | N | — | ODE-265 + ODE-313 + ODE-448
Full coverage date: —
| Source |
| ODE-448 | 2023-10-20 | 2030-10-20 | English description not available. | N | N | — | — | Source |
| ODE-448 | 2023-10-20 | 2030-10-20 | English description not available. | N | N | — | ODE-265 + ODE-313 + ODE-448
Full coverage date: —
| 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 (20)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-07-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2028-07-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2028-07-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2028-07-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2028-07-08 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-03-10 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-05-22 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-05-22 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-17 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2035-02-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2037-05-18 | FTO_TAIL | English description not available. | Source |
| PATENT | 2037-05-18 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-07-18 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-07-18 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2035-02-17 | 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.