ERLEADA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_RIGHTS
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8802689 | 2027-03-27 | U U-2624 | N | Y | DS_EQUIVALENT | — | — | — |
| 8802689 | 2027-03-27 | U U-2237 | N | Y | DS_EQUIVALENT | — | — | — |
| 9388159 | 2027-03-27 | DS/DP — | Y | N | TRUE_DS | — | — | — |
| 9987261 | 2027-03-27 | DP — | N | N | DP | — | — | — |
| 8445507 | 2032-02-14 | DS/DP/U U-2237 | Y | N | TRUE_DS | — | — | — |
| 8445507 | 2032-02-14 | DS/DP/U U-2624 | Y | N | TRUE_DS | — | — | — |
| 9481663 | 2033-06-04 | DS/DP/U U-2624 | N | N | DP | — | — | — |
| 9481663 | 2033-06-04 | DS/DP/U U-2237 | N | N | DP | — | — | — |
| 10849888 | 2033-09-23 | U U-3013 | N | N | U | — | — | — |
| 9884054 | 2033-09-23 | U U-2237 | N | N | U | — | — | — |
| RE49353 | 2033-09-23 | U U-2381 | N | N | U | — | — | — |
| RE50642 | 2033-09-23 | U U-4450 | N | N | U | — | — | — |
| 12303493 | 2035-12-03 | DP — | N | N | DP | — | — | — |
| 10702508 | 2038-04-30 | U U-3012 | N | N | U | — | — | — |
| 11963952 | 2040-01-30 | U U-3901 | N | N | U | — | — | — |
| 12303497 | 2040-01-30 | U U-4494 | N | N | U | — | — | — |
| 12303497 | 2040-01-30 | U U-4448 | N | N | U | — | — | — |
| 11723898 | 2041-01-14 | U U-4449 | N | N | U | — | — | — |
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 | 2032-02-14 | CANONICAL_DECISION | POST_ANCHOR_RIGHTS | 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 |
|---|---|---|---|---|---|
| 2026-05-01 | Hetero | SETTLEMENT Brand-level record; strength scope not established
|
Not disclosed | REVIEW | — |
| 240 mg strength-specific reported settlement, no public entry date | |||||