CAMZYOS
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2036. Anchor type: TRUE_DS_OR_DS_EQ_PATENT. Patent anchor: 2036-04-28. Exclusivity anchor: 2027-04-28. Anchor date: 2036-04-28. Patent tail: no. 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
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-297 | — | 2026-06-15 | — | — | — | — | Source | |
| NCE | — | 2027-04-28 | — | — | — | — | Source | |
| ODE-398 | — | 2029-04-28 | — | — | — | — | 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 | USRE50050 c1 TRUE_DS; FDA2036-04-28 includes PTE679 days. No double addition. Pediatric OOPD TBD is not a dated granted right. Four exact strengths retained. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2036 | CANDIDATE | FINAL | 2036-04-28 | 2026-10-17 23:57:57 |
| N | 2036 | CANDIDATE | FINAL | 2036-04-28 | 2026-10-14 10:16:20 |
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.