Product profile · United States
TECFIDERA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8399514 | 2028-02-07 | U U-1384 | — | — | — | — | — | — |
| 10391160 | 2035-03-13 | U U-3148 | — | — | — | — | — | — |
| 10555993 | 2035-03-13 | U U-3148 | — | — | — | — | — | — |
| 10994003 | 2035-03-13 | U U-3148 | — | — | — | — | — | — |
| 10959972 | 2035-11-16 | U U-1384 | — | — | — | — | — | — |
| 11007166 | 2035-11-16 | U U-1384 | — | — | — | — | — | — |
| 11007167 | 2035-11-16 | U U-1384 | — | — | — | — | — | — |
| 11129806 | 2035-11-16 | U U-1384 | — | — | — | — | — | — |
| 11246850 | 2035-11-16 | U U-1384 | — | — | — | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 210291 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SHILPA MEDICARE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210531 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-17 | — | MYLAN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210305 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | CIPLA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210402 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | AMNEAL EU LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210440 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | ALKEM LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210460 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210499 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | ACCORD HEALTHCARE INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210500 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210538 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210226 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-05 | — | LUPIN INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210309 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-06 | — | GLENMARK PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210382 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-14 | — | TWI PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210436 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-26 | — | SOLA PHARMACEUTICALS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210285 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-12-21 | — | SAWAI USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210414 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-10-18 | — | PRINSTON PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210385 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-12-22 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210377 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2024-06-26 | — | MACLEODS PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210390 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-01-06 | — | TORRENT PHARMACEUTICALS LTD | 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 17 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 |
|---|---|---|---|---|---|---|
| 210531 / 002 | MYLAN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210305 / 002 | CIPLA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210402 / 002 | AMNEAL EU LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210440 / 002 | ALKEM LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210460 / 002 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210499 / 002 | ACCORD HEALTHCARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210500 / 002 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210538 / 002 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210226 / 002 | LUPIN INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210309 / 002 | GLENMARK PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210382 / 002 | TWI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210436 / 002 | SOLA PHARMACEUTICALS | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210285 / 002 | SAWAI USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-12-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210414 / 002 | PRINSTON PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2022-10-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210385 / 002 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-12-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210377 / 002 | MACLEODS PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-06-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210390 / 002 | TORRENT PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-01-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC | 2020-08-17 | TERMINAL_GENERIC_BASIS | Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted. | 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.