Product profile · United States
PROMACTA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_DISCONTINUED; FDA DISC action month 2019-02
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7547719 | 2025-07-13 | DS/DP/U U-1306 | — | — | — | — | — | — |
| 7547719 | 2025-07-13 | DS/DP/U U-930 | — | — | — | — | — | — |
| 7547719 | 2025-07-13 | DS/DP/U U-1575 | — | — | — | — | — | — |
| 7547719 | 2026-01-13 | — — | — | — | — | — | 2026-01-13 | — |
| 7547719 | 2026-01-13 | ORANGE_BOOK U-1306,U-1575,U-930 | N | Y | DS_EQUIVALENT English description not available. | — | 2026-01-13 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2008-11-20 | 2013-11-20 | NEW CHEMICAL ENTITY | Y | Y | 2013-11-20 | Source | |
| I-664 | 2012-11-16 | 2015-11-16 | TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY | N | N | — | Source | |
| ODE | 2008-11-20 | 2015-11-20 | ORPHAN DRUG EXCLUSIVITY | N | N | — | Source | |
| D-149 | 2015-06-11 | 2018-06-11 | DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP | N | N | — | Source | |
| I-711 | 2015-06-11 | 2018-06-11 | INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY | N | N | — | Source | |
| PED | 2018-06-11 | 2018-12-11 | English description not available. | N | N | — | Source | |
| ODE | 2014-08-26 | 2021-08-26 | ORPHAN DRUG EXCLUSIVITY | N | N | — | Source | |
| ODE-75 | 2014-08-26 | 2021-08-26 | TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY | N | N | — | Source | |
| PED | 2021-08-26 | 2022-02-26 | English description not available. | N | N | — | Source | |
| ODE-210 | 2018-11-16 | 2025-11-16 | INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA | N | N | — | 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 (12)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-01-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | NEW CHEMICAL ENTITY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | ORPHAN DRUG EXCLUSIVITY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | ORPHAN DRUG EXCLUSIVITY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA_DISCONTINUED; FDA DISC action month 2019-02 | Source |
Independent legal-event information
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.
No litigation or settlement record currently linked to this product.