DOJOLVI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Full-scope ODE-311 anchor 2027-06-30; later DP tail 2034-11-14; formulation/purity limitations do not automatically establish DS-equivalent coverage.
Patent estate
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE-311 | — | 2027-06-30 | — | — | — | — | Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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. | ||||||
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 |
|---|---|---|---|---|---|
| 2026-10-19 | Navinta LLC | SETTLEMENT Brand-level record; strength scope not established
|
2033-01-01 | SOURCE_CONFIRMED | Source |
| tracking_id=US-N213687-NAVINTA-20261019-SETTLEMENT; 비독점·무로열티 회사별 license: 기본2033-01-01, PED 부여시2033-07-01, 통상 조기 조건/예외. 타 ANDA 소송 계속. 최초 Final ANDA/실제 출시·전제품 보호앵커로 사용하지 않음. master/strength 링크 미확인.; verified source 2026-10-24. No Final approval, global legal anchor or actual launch inferred. | |||||
| 2026-08-07 | Esjay Pharma Private Limited / Esjay Pharma LLC | SETTLEMENT Brand-level record; strength scope not established
|
2033-01-01 | SOURCE_CONFIRMED | Source |
| tracking_id=US-N213687-ESJAY-20260807-SETTLEMENT; 비독점·무로열티 회사별 license: 기본2033-01-01, PED 부여시2033-07-01, 통상 조기 조건/예외. 타 ANDA 소송 계속. 최초 Final ANDA/실제 출시·전제품 보호앵커로 사용하지 않음. master/strength 링크 미확인.; verified source 2026-10-24. No Final approval, global legal anchor or actual launch inferred. | |||||