OMCAZIO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_TAIL: The recovered Handa lauryl-sulfate crystal/formulation family remains after the 2026 compound anchor. It includes issued US12415784, US12516025, US12516026, US12522567 and US12552749. US12522567 representative issued claim has formulation, exposure and dosing limits, so it is formulation-limited U/DP, not DS-equivalent. US12064430 also claims cabozantinib lauryl-sulfate capsule treatment with excipient/PK limits. Dasatinib US12064428 is excluded. Historical malate-only claims, thyroid/pNET orphan awards outside the target indication and fee-lapsed US11141413 are not used as the deciding tail. US12415784 independent claims 1 and 4 are XRPD-limited crystalline salts; classification corrected from DP to OTHER_CRYSTAL.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7579473 | 2026-08-14 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | Y | N | TRUE_DS Cabozantinib free-compound/salt claim; historical FDA reference end includes the granted PTE. 35 USC 156(f)(2) includes salts/esters, and the extended product rights cover approved uses. The laurylsulfate change is not grounds to discard the compound family. Malate-specific later claims remain separate. The historical compound anchor precedes target approval. | — | — | — |
| 12064430 | 2039-06-13 | U U-1480 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12064430 | 2039-06-13 | U U-2488 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12516025 | 2044-01-30 | U U-1480 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12516025 | 2044-01-30 | U U-2488 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12516025 | 2044-01-30 | U U-4131 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12552567 | 2044-01-30 | U U-4131 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12552567 | 2044-01-30 | U U-2488 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12552567 | 2044-01-30 | U U-1480 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12552749 | 2044-01-30 | U U-4131 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12552749 | 2044-01-30 | U U-2488 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12552749 | 2044-01-30 | U U-1480 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 12741938 | 2044-01-30 | DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| US12415784 | 2044-01-30 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | N | N | OTHER_CRYSTAL The recovered Handa lauryl-sulfate crystal/formulation family remains after the 2026 compound anchor. It includes issued US12415784, US12516025, US12516026, US12522567 and US12552749. US12522567 representative issued claim has formulation, exposure and dosing limits, so it is formulation-limited U/DP, not DS-equivalent. US12064430 also claims cabozantinib lauryl-sulfate capsule treatment with excipient/PK limits. Dasatinib US12064428 is excluded. Historical malate-only claims, thyroid/pNET orphan awards outside the target indication and fee-lapsed US11141413 are not used as the deciding tail. US12415784 independent claims 1 and 4 are XRPD-limited crystalline salts; classification corrected from DP to OTHER_CRYSTAL. | — | — | — |
| US12415784 | 2044-01-30 | — — | — | — | — 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 |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
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 | 2026-08-14 | CANONICAL_ANCHOR | Cabozantinib free-compound/salt claim; historical FDA reference end includes the granted PTE. 35 USC 156(f)(2) includes salts/esters, and the extended product rights cover approved uses. The laurylsulfate change is not grounds to discard the compound family. Malate-specific later claims remain separate. The historical compound anchor precedes target approval. | Source |
| PATENT | 2044-01-30 | FTO_TAIL | The recovered Handa lauryl-sulfate crystal/formulation family remains after the 2026 compound anchor. It includes issued US12415784, US12516025, US12516026, US12522567 and US12552749. US12522567 representative issued claim has formulation, exposure and dosing limits, so it is formulation-limited U/DP, not DS-equivalent. US12064430 also claims cabozantinib lauryl-sulfate capsule treatment with excipient/PK limits. Dasatinib US12064428 is excluded. Historical malate-only claims, thyroid/pNET orphan awards outside the target indication and fee-lapsed US11141413 are not used as the deciding tail. US12415784 independent claims 1 and 4 are XRPD-limited crystalline salts; classification corrected from DP to OTHER_CRYSTAL. | Source |
| REGULATORY_STATUS | 2026-08-14 | CANONICAL_DECISION | POST_ANCHOR_TAIL: The recovered Handa lauryl-sulfate crystal/formulation family remains after the 2026 compound anchor. It includes issued US12415784, US12516025, US12516026, US12522567 and US12552749. US12522567 representative issued claim has formulation, exposure and dosing limits, so it is formulation-limited U/DP, not DS-equivalent. US12064430 also claims cabozantinib lauryl-sulfate capsule treatment with excipient/PK limits. Dasatinib US12064428 is excluded. Historical malate-only claims, thyroid/pNET orphan awards outside the target indication and fee-lapsed US11141413 are not used as the deciding tail. US12415784 independent claims 1 and 4 are XRPD-limited crystalline salts; classification corrected from DP to OTHER_CRYSTAL. | 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.