ZILXI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2030. Anchor type: DS_EQUIVALENT. Patent anchor: 2030-10-01. Exclusivity anchor: not recorded. Anchor date: 2030-10-01. Patent tail: no. Exclusivity tail: no. Review status: FINAL_CHECKING. 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 |
|---|---|---|---|---|---|---|---|---|
| 10213512 | 2030-10-01 | DP/U U-1631 | — | — | — | — | — | — |
| 10265404 | 2030-10-01 | DP — | — | — | — | — | — | — |
| 10322186 | 2030-10-01 | U U-1631 | — | — | — | — | — | — |
| 10946101 | 2030-10-01 | U U-1631 | — | — | — | — | — | — |
| 12138311 | 2030-10-01 | U U-1631 | — | — | — | — | — | — |
| 12661407 | 2030-10-01 | U U-1631 | — | — | — | — | — | — |
| 8865139 | 2030-10-01 | DP/U U-1631 | — | — | — | — | — | — |
| 8945516 | 2030-10-01 | DP — | — | — | — | — | — | — |
| 8992896 | 2030-10-01 | DP/U U-1631 | — | — | — | — | — | — |
| 9675700 | 2030-10-01 | DP/U U-1631 | — | — | — | — | — | — |
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. | ||||||||
2026-10-10 · 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 1 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.
| Challenger / ANDA | Event | Lawsuit filed | Dismissal | Announcement | Settlement entry | Approval | Evidence |
|---|---|---|---|---|---|---|---|
| Padagis / 217148 | PARAGRAPH_IV | 2022-05-02 | 2022-05-19 | 2022-05-24 | 2027-04-01 | NOT_ESTABLISHED | SOURCE_DOCUMENTED |
| P4 challenge documented by complaint; challenge/certification submission date not verified. Lawsuit and settlement are separate legal milestones. No final FDA approval inferred. | |||||||
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|
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. | ||||||
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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2022-05-24 | Padagis | SETTLEMENT | 2027-04-01 | REVIEW | — |
| Brand-specific license; confirm original manufacturer release | |||||