NERLYNX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_RIGHTS_EXIST
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10035788 | 2028-10-15 | U U-3097 | — | — | — | — | — | — |
| 10035788 | 2028-10-15 | U U-3047 | — | — | — | — | — | — |
| 10035788 | 2028-10-15 | U U-2043 | — | — | — | — | — | — |
| 9139558 | 2028-10-15 | U U-2043 | — | — | — | — | — | — |
| 9139558 | 2028-10-15 | U U-3047 | — | — | — | — | — | — |
| 9139558 | 2028-10-15 | U U-3097 | — | — | — | — | — | — |
| 9630946 | 2028-10-15 | U U-2043 | — | — | — | — | — | — |
| 9630946 | 2028-10-15 | U U-3097 | — | — | — | — | — | — |
| 9630946 | 2028-10-15 | U U-3047 | — | — | — | — | — | — |
| 9265784 | 2029-08-04 | U U-3047 | — | — | — | — | — | — |
| 9211291 | 2030-03-24 | U U-2043 | — | — | — | — | — | — |
| 9211291 | 2030-03-24 | U U-3097 | — | — | — | — | — | — |
| 8790708 | 2030-11-05 | DP/U U-2043 | — | — | — | — | — | — |
| 8790708 | 2030-11-05 | DP/U U-3097 | — | — | — | — | — | — |
| 8790708 | 2030-11-05 | DP/U U-3047 | — | — | — | — | — | — |
| 8518446 | 2030-11-20 | DP/U U-2043 | — | — | — | — | — | — |
| 8518446 | 2030-11-20 | DP/U U-3097 | — | — | — | — | — | — |
| 8518446 | 2030-11-20 | DP/U U-3047 | — | — | — | — | — | — |
| 7399865 | 2030-12-29 | DS/DP — | — | — | — | — | — | — |
| 8669273 | 2031-07-18 | U U-3047 | — | — | — | — | — | — |
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 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 |
|---|---|---|---|---|
| REGULATORY_STATUS | 2030-12-29 | CANONICAL_DECISION | POST_ANCHOR_RIGHTS_EXIST | 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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2022-12-13 | Sandoz | SETTLEMENT | Not disclosed | REVIEW | — |
| Entry date not established | |||||