ROZLYTREK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Issued entrectinib compound claims map to the API. Effective date 2032-03-10 is also currently FDA-posted for capsule reference products; the substance scope transfers to the pellets. Pellet label contains solid tartaric acid: US10398693 claim 1 maps to entrectinib plus solid acidulant, with term 2038-07-18. US11253515 capsule-only claims are not automatically transferred.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8299057 | 2032-03-10 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | Y | N | TRUE_DS Issued entrectinib compound claims map to the API. Effective date 2032-03-10 is also currently FDA-posted for capsule reference products; the substance scope transfers to the pellets. Pellet label contains solid tartaric acid: US10398693 claim 1 maps to entrectinib plus solid acidulant, with term 2038-07-18. US11253515 capsule-only claims are not automatically transferred. | — | — | — |
| 10398693 | 2038-07-18 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | N | N | DP Issued entrectinib compound claims map to the API. Effective date 2032-03-10 is also currently FDA-posted for capsule reference products; the substance scope transfers to the pellets. Pellet label contains solid tartaric acid: US10398693 claim 1 maps to entrectinib plus solid acidulant, with term 2038-07-18. US11253515 capsule-only claims are not automatically transferred. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE* | — | 2026-08-15 | Inherited ODE-protected uses of another same-moiety drug; not a recognized ODE grant to this application. | N | N | — | — | Source |
| ODE* | 2019-08-15 | 2026-08-15 | Inherited ODE-protected uses of another same-moiety drug; not a recognized ODE grant to this application. | N | N | — | — | Source |
| NP | — | 2026-10-20 | New exact product/presentation based on essential clinical investigations. | Y | Y | — | — | Source |
| NP | 2023-10-20 | 2026-10-20 | New exact product/presentation based on essential clinical investigations. | Y | Y | 2026-10-20 | — | Source |
| ODE-448 | — | 2030-10-20 | TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY | N | N | — | — | Source |
| ODE-448 | 2023-10-20 | 2030-10-20 | TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY | N | N | — | — | Source |
2026-10-13 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_AND_MONTHLY_REVIEWED
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 (6)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2032-03-10 | CANONICAL_ANCHOR | Issued entrectinib compound claims map to the API. Effective date 2032-03-10 is also currently FDA-posted for capsule reference products; the substance scope transfers to the pellets. Pellet label contains solid tartaric acid: US10398693 claim 1 maps to entrectinib plus solid acidulant, with term 2038-07-18. US11253515 capsule-only claims are not automatically transferred. | Source |
| PATENT | 2038-07-18 | FTO_TAIL | Issued entrectinib compound claims map to the API. Effective date 2032-03-10 is also currently FDA-posted for capsule reference products; the substance scope transfers to the pellets. Pellet label contains solid tartaric acid: US10398693 claim 1 maps to entrectinib plus solid acidulant, with term 2038-07-18. US11253515 capsule-only claims are not automatically transferred. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Inherited ODE-protected uses of another same-moiety drug; not a recognized ODE grant to this application. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY | Source |
| REGULATORY_EXCLUSIVITY | 2026-10-20 | CANONICAL_ANCHOR | New exact product/presentation based on essential clinical investigations. | Source |
| REGULATORY_STATUS | 2032-03-10 | CANONICAL_DECISION | Issued entrectinib compound claims map to the API. Effective date 2032-03-10 is also currently FDA-posted for capsule reference products; the substance scope transfers to the pellets. Pellet label contains solid tartaric acid: US10398693 claim 1 maps to entrectinib plus solid acidulant, with term 2038-07-18. US11253515 capsule-only claims are not automatically transferred. | 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.