BELEODAQ
· 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 |
|---|---|---|---|---|---|---|---|---|
| 6888027 | 2026-08-10 | DS/DP/U U-1544 | Y | N | TRUE_DS | BELEODAQ_20261023: 6888027 classified TRUE_DS; original DS/DP flags and expiry restored; current judgment not modified. | — | — | — |
| 8835501 | 2027-10-27 | DP — | N | N | DP | BELEODAQ_20261023: 8835501 classified DP; original DS/DP flags and expiry restored; current judgment not modified. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2014-07-03 | 2019-07-03 | NCE exclusivity; entire approved new active moiety | Y | Y | — | — | Source |
| ODE-68 | 2014-07-03 | 2021-07-03 | Orphan drug exclusivity for FDA-approved relapsed/refractory PTCL indication at initial approval | Y | Y | — | — | Source |
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 | 2026-08-10 | 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 |
|---|---|---|---|---|---|
| 2018-10-03 | Acrotech Biopharma, LLC / Spectrum Pharmaceuticals, Inc. / TopoTarget UK Ltd. v. Fresenius Kabi USA, LLC et al. | LITIGATION Brand-level record; strength scope not established
|
Not disclosed | SOURCE_CONFIRMED | Source |
| Case 1:18-cv-01533 (D. Del.); filed 2018-10-03; terminated by dismissal order reflected in docket 2020-12-02. Patents US6888027 (DS compound) and US8835501 (DP formulation); ANDA 211485, Fresenius generic belinostat 500 mg/vial. Docket shows mediation/settlement discussions but does not establish publicly disclosed agreed generic entry date. Do not record as a confirmed settlement or infer 2027-10-27 entry permission. GNR 2026 DEEP_REVIEW and anchor 2026-08-10 unchanged. | |||||