Product profile · United States
Eylea
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2024. Anchor type: EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2024-05-18. Anchor date: 2024-05-18. 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 |
|---|---|---|---|---|---|---|---|---|
| 10857231 | — | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7070959 | 2023-06-16 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10406226 | 2026-03-22 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10464992 | 2027-06-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11066458 | 2027-06-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11084865 | 2027-06-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11732024 | 2027-06-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10415055 | 2028-06-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9562238 | 2028-06-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9932605 | 2028-06-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7771997 | 2028-07-02 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9222106 | 2028-07-02 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10130681 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10828345 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10857205 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10888601 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11253572 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11559564 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11707506 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11975045 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11986511 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12268730 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9669069 | 2032-01-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9254338 | 2032-05-22 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11332771 | 2034-03-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11970724 | 2034-03-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D858754 | 2034-09-03 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9315281 | 2034-09-16 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11268109 | 2035-10-21 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11788102 | 2035-10-21 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9816110 | 2035-10-21 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D906102 | 2035-12-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10927342 | 2036-08-03 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11312936 | 2036-08-03 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12221619 | 2036-08-03 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D934069 | 2036-10-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11549154 | 2036-12-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10669594 | 2037-02-12 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11918785 | 2037-06-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10182969 | 2037-07-13 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D961376 | 2037-08-23 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D961377 | 2037-08-23 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11577025 | 2037-10-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11680930 | 2037-10-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10905786 | 2038-03-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10918754 | 2038-03-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12116622 | 2038-05-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11769597 | 2038-08-15 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11433186 | 2038-12-12 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12168036 | 2039-05-10 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11103552 | 2039-05-15 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10973879 | 2039-05-17 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12280093 | 2039-05-17 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D1035436 | 2039-07-16 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D1042107 | 2039-09-17 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11850407 | 2039-09-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| D1047700 | 2039-10-22 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10961500 | 2040-01-27 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11286460 | 2040-01-27 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11555176 | 2040-01-27 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11821001 | 2040-01-27 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11439758 | 2040-06-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11478588 | 2040-07-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11160918 | 2040-07-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11793926 | 2040-07-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11053280 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11104715 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11174283 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11186625 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11299532 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11306135 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11459373 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11459374 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11472861 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11485770 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11505593 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11535663 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11542317 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11548932 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11649273 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11732025 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11753459 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12054533 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12077570 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12202883 | 2040-08-18 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11525833 | 2040-11-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12282004 | 2041-12-09 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12163122 | 2042-05-10 | 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 |
|---|---|---|---|---|---|---|---|---|
| Ref. Product Exclusivity Exp. Date | — | 2024-05-18 | — | — | — | — | Source | |
| Orphan Exclusivity Exp. Date | — | 2030-02-08 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 761274 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-05-20 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761274 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761350 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761350 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-05-20 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761378 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | — | Formycon AG | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761382 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-09 | — | Sandoz Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761382 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-09 | — | Sandoz Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761298 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-23 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761298 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-23 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761378 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-04-17 | — | Formycon AG | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761377 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-10-02 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761377 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-10-02 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761274 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-01-13 | — | Biocon Biologics Inc. | 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 11 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 |
|---|---|---|---|---|---|---|
| 761274 / 001 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-05-20 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761350 / 001 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-05-20 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761378 / 001 | Formycon AG | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761382 / 001 | Sandoz Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-09 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761382 / 002 | Sandoz Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-09 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761298 / 001 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-23 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761298 / 002 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-08-23 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761378 / 002 | Formycon AG | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-04-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761377 / 001 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-10-02 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761377 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-10-02 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761274 / 002 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-01-13 | 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.