Product profile · United States
FERRIPROX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Available evidence does not establish a full-scope DS/DS-equivalent or full-coverage exclusivity anchor; approval-year DEEP_REVIEW is proposed. Direct Final-ANDA linkage may change the result.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10780055 | 2038-10-25 | DP/U U-3083 | N | N | FORMULATION_OR_PK | — | — | — |
| 10780055 | 2038-10-25 | DP/U U-3083 | N | N | FORMULATION_OR_PK Deferiprone enteric polymer core/coat and split-tablet bioequivalence limitations; treatment claims also reference this formulation. | — | — | — |
| 10940115 | 2038-10-25 | DP/U U-3083 | N | N | FORMULATION_OR_PK | — | — | — |
| 10940115 | 2038-10-25 | DP/U U-3083 | N | N | FORMULATION_OR_PK Deferiprone 1000 mg with core enteric polymer 1-5% and fixed excipient/coat limitations. | — | — | — |
| 10940116 | 2038-10-25 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 10940116 | 2038-10-25 | DP — | N | N | FORMULATION_OR_PK Deferiprone 1000 mg enteric core/coat, BID or AUC/Cmax 3.5-6, with polymer/base-excipient limitations. | — | — | — |
| 11357731 | 2038-10-25 | U U-3083 | N | N | FORMULATION_OR_PK | — | — | — |
| 11357731 | 2038-10-25 | U U-3083 | N | N | FORMULATION_OR_PK Iron-overload treatment limited to thalassemia/sickle-cell disease and a 1000 mg enteric core/coat; excludes other anemias. | — | — | — |
| 11458103 | 2038-10-25 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 11458103 | 2038-10-25 | DP — | N | N | FORMULATION_OR_PK Deferiprone BID versus IR TID 24-hour bioequivalence or AUC/Cmax 3.5-6 functional formulation conditions; necessity across the entire product requires further verification. | — | — | — |
| 11723874 | 2038-10-25 | U U-3083 | N | N | FORMULATION_RESTRICTED_USE | — | — | — |
| 11723874 | 2038-10-25 | U U-3083 | N | N | FORMULATION_RESTRICTED_USE Claim 1: treatment of thalassemia iron overload using a specific core/enteric-coated 1000 mg tablet. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE-417 | 2021-04-30 | 2028-04-30 | Adult thalassemia iron overload; excludes the adult scope approved in 2011. | N | N | — | ODE-417 + ODE-420 + ODE-421
Full coverage date: —
Existing adult thalassemia treatment scope included in the 2011 approval. | Source |
| ODE-417 | 2021-04-30 | 2028-04-30 | Adult thalassemia iron overload; excludes the adult scope approved in 2011. | N | N | — | ODE-417 + ODE-420 + ODE-421
Full coverage date: —
Existing adult thalassemia treatment scope included in the 2011 approval. | Source |
| ODE-420 | 2021-04-30 | 2028-04-30 | Thalassemia iron overload in pediatric patients aged eight years and older. | N | N | — | ODE-417 + ODE-420 + ODE-421
Full coverage date: —
Existing adult thalassemia treatment scope included in the 2011 approval. | Source |
| ODE-420 | 2021-04-30 | 2028-04-30 | Thalassemia iron overload in pediatric patients aged eight years and older. | N | N | — | ODE-417 + ODE-420 + ODE-421
Full coverage date: —
Existing adult thalassemia treatment scope included in the 2011 approval. | Source |
| ODE-421 | 2021-04-30 | 2028-04-30 | Iron overload in pediatric patients aged eight years and older and adults with sickle-cell disease/other anemias. | N | N | — | ODE-417 + ODE-420 + ODE-421
Full coverage date: —
Existing adult thalassemia treatment scope included in the 2011 approval. | Source |
| ODE-421 | 2021-04-30 | 2028-04-30 | Iron overload in pediatric patients aged eight years and older and adults with sickle-cell disease/other anemias. | N | N | — | ODE-417 + ODE-420 + ODE-421
Full coverage date: —
Existing adult thalassemia treatment scope included in the 2011 approval. | Source |
2026-10-10 · CURRENT_SNAPSHOT_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 213239 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-08 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208800 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2023-11-22 | — | TARO PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 220132 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-11 | — | SENORES PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 3 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 |
|---|---|---|---|---|---|---|
| 213239 / 002 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208800 / 002 | TARO PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-11-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 220132 / 002 | SENORES PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (9)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2038-10-25 | FTO_TAIL | Deferiprone BID versus IR TID 24-hour bioequivalence or AUC/Cmax 3.5-6 functional formulation conditions; necessity across the entire product requires further verification. | Source |
| PATENT | 2038-10-25 | FTO_TAIL | Deferiprone 1000 mg with core enteric polymer 1-5% and fixed excipient/coat limitations. | Source |
| PATENT | 2038-10-25 | FTO_TAIL | Iron-overload treatment limited to thalassemia/sickle-cell disease and a 1000 mg enteric core/coat; excludes other anemias. | Source |
| PATENT | 2038-10-25 | FTO_TAIL | Deferiprone 1000 mg enteric core/coat, BID or AUC/Cmax 3.5-6, with polymer/base-excipient limitations. | Source |
| PATENT | 2038-10-25 | FTO_TAIL | Deferiprone enteric polymer core/coat and split-tablet bioequivalence limitations; treatment claims also reference this formulation. | Source |
| PATENT | 2038-10-25 | FTO_TAIL | Claim 1: treatment of thalassemia iron overload using a specific core/enteric-coated 1000 mg tablet. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Adult thalassemia iron overload; excludes the adult scope approved in 2011. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Iron overload in pediatric patients aged eight years and older and adults with sickle-cell disease/other anemias. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Thalassemia iron overload in pediatric patients aged eight years and older. | 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.