ETCAMAH
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
NO_POST_ANCHOR_TAIL_IDENTIFIED: The previously adopted full-indication DS-equivalent inference is retained with the 2041-09-18 end. Other recovered issued compound/solid-form family terms precede this anchor. Later breast-cancer/combination applications and US20250352531 remain pending and are tracked separately, not counted as issued tails. Dose-adjustment exceptions are preserved in the anchor basis.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10590130 | 2037-10-13 | DS;DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 10961241 | 2037-10-13 | U U-4607 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12077530 | 2037-10-13 | U U-4607 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| US10131663 | 2037-10-13 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | Y | N | TRUE_DS Original camizestrant compound end precedes the selected full-indication DS-equivalent anchor. | — | — | — |
| US10131663 | 2037-10-13 | DS;DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| US12364689 | 2041-09-18 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | N | Y | DS_EQUIVALENT GNR full-indication inference: claim 1 covers camizestrant oral 75 mg once daily in ER-positive/HER2-negative breast cancer; claim 4 permits additional anticancer therapy. FDA sections 1, 2.2 and 14 identify the single current ESR1-mutated breast-cancer indication, ER-positive pivotal population and recommended 75 mg regimen. Alternative dose adjustments are not separate approved indications and are not asserted to literally meet this claim. This operational DS-equivalent classification concerns full-indication coverage, not every administration. 2021-04-22 + 20 years + 149 PTA days = 2041-09-18. | — | — | — |
| US12364689 | 2041-09-18 | U U-4606 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12453729 | 2041-10-22 | DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | — | 2031-09-04 | — | — | — | — | Source |
2026-10-13 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · Historical coverage: ANNUALS_AND_MONTHLY_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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 (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2037-10-13 | HISTORICAL_CONTEXT | Original camizestrant compound end precedes the selected full-indication DS-equivalent anchor. | Source |
| PATENT | 2041-09-18 | CANONICAL_ANCHOR | GNR full-indication inference: claim 1 covers camizestrant oral 75 mg once daily in ER-positive/HER2-negative breast cancer; claim 4 permits additional anticancer therapy. FDA sections 1, 2.2 and 14 identify the single current ESR1-mutated breast-cancer indication, ER-positive pivotal population and recommended 75 mg regimen. Alternative dose adjustments are not separate approved indications and are not asserted to literally meet this claim. This operational DS-equivalent classification concerns full-indication coverage, not every administration. 2021-04-22 + 20 years + 149 PTA days = 2041-09-18. | Source |
| REGULATORY_STATUS | 2041-09-18 | CANONICAL_DECISION | NO_POST_ANCHOR_TAIL_IDENTIFIED: The previously adopted full-indication DS-equivalent inference is retained with the 2041-09-18 end. Other recovered issued compound/solid-form family terms precede this anchor. Later breast-cancer/combination applications and US20250352531 remain pending and are tracked separately, not counted as issued tails. Dose-adjustment exceptions are preserved in the anchor basis. | 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.