Product profile · United States
Actemra
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2022. Anchor type: EXCLUSIVITY. Patent anchor: 2019-04-17. Exclusivity anchor: 2022-07-08. Anchor date: 2022-07-08. Patent tail: not established. Exclusivity tail: not established. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7332289 | 2023-08-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10744201 | 2024-04-28 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7521052 | 2024-04-28 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8709409 | 2024-06-22 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8734800 | 2025-03-24 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9902777 | 2025-05-28 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8617550 | 2026-03-03 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8398980 | 2028-02-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11078294 | 2028-07-08 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8574869 | 2028-07-08 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11008394 | 2028-12-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11359026 | 2028-12-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11584798 | 2028-12-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11136375 | 2029-07-19 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8568720 | 2029-11-05 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10982003 | 2030-08-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9714293 | 2030-08-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10501769 | 2030-10-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11021728 | 2030-10-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11136610 | 2030-10-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11377678 | 2030-10-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8512983 | 2031-01-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10662237 | 2031-08-07 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11667720 | 2031-11-07 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8580264 | 2031-11-07 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10231981 | 2031-12-03 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10874677 | 2032-03-02 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9539263 | 2032-05-23 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9750752 | 2032-08-30 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10590164 | 2033-03-19 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9630988 | 2033-06-13 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10676710 | 2034-03-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10829732 | 2034-03-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10017732 | 2034-12-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10336983 | 2035-07-31 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| Orphan Exclusivity Exp. Date | — | 2025-02-28 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 761354 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-09-29 | — | Biogen MA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761354 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-09-29 | — | Biogen MA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761354 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-09-29 | — | Biogen MA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761275 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761275 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761275 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761420 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761420 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761420 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761420 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761420 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761420 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761498 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761498 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761498 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761449 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-14 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761449 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-14 | — | Fresenius Kabi USA, LLC | N | REFERENCE_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 13 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 |
|---|---|---|---|---|---|---|
| 761354 / 001 | Biogen MA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-09-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761354 / 002 | Biogen MA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-09-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761354 / 003 | Biogen MA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-09-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761275 / 001 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761275 / 002 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761275 / 003 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761420 / 001 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761420 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761420 / 003 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761498 / 001 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761498 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-01-24 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761449 / 001 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-14 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761449 / 002 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-14 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| BLA_PATENT_EXCLUSIVITY_REVIEW | — | BUSINESS_CLASSIFICATION_WITH_CONDITIONS | English description not available. | 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.