Product profile · United States
Xgeva
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2025. Anchor type: PATENT. Patent anchor: 2025-02-19. Exclusivity anchor: 2022-06-01. Anchor date: 2025-02-19. 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 |
|---|---|---|---|---|---|---|---|---|
| 8058418 | 2023-11-30 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7364736 | 2025-02-19 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7427659 | 2025-03-15 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8247210 | 2026-12-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8460896 | 2026-12-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8680248 | 2026-12-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8217153 | 2027-01-05 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7928205 | 2027-02-12 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7888101 | 2027-04-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7662930 | 2027-04-24 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9359435 | 2027-05-22 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8053236 | 2030-01-19 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9228168 | 2030-01-19 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9320816 | 2030-11-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9012178 | 2031-08-05 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9133493 | 2032-04-20 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9388447 | 2032-04-20 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11292829 | 2032-06-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11634476 | 2032-06-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11685772 | 2032-06-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9371554 | 2032-12-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11293930 | 2033-03-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11486883 | 2033-03-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9328134 | 2034-02-20 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11319568 | 2034-03-10 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11459595 | 2034-03-10 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11952605 | 2034-03-10 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12084686 | 2034-03-10 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11492372 | 2034-03-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10421987 | 2034-05-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10894972 | 2034-05-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11434514 | 2034-05-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11946085 | 2034-05-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9481901 | 2034-05-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9803166 | 2034-09-29 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11299760 | 2034-10-30 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10513723 | 2034-12-09 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11254963 | 2034-12-09 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10106829 | 2034-12-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10227627 | 2034-12-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10655156 | 2034-12-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10907186 | 2034-12-11 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11130980 | 2035-04-05 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11077404 | 2035-05-13 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11384378 | 2035-06-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11427848 | 2035-06-04 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10583397 | 2035-07-28 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11786866 | 2035-10-21 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11192919 | 2035-11-13 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10167492 | 2035-12-01 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10822630 | 2035-12-01 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11275090 | 2037-07-02 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11098079 | 2037-07-21 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9881367 | 2037-08-09 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12025618 | 2039-08-26 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 11744950 | 2039-11-21 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 12059555 | 2040-09-02 | 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 | — | 2021-12-05 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 761362 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | — | Sandoz Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761362 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Sandoz Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761392 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-02-13 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761404 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-02-28 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761398 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-25 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761398 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-25 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761444 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-08-29 | — | Shanghai Henlius Biotech, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761436 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-09-16 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761439 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-09-26 | — | Hikma Pharmaceuticals USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761392 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761398 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761398 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761404 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761424 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761424 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-10-29 | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761436 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761439 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Hikma Pharmaceuticals USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761444 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Shanghai Henlius Biotech, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761457 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-12-19 | — | Amneal Pharmaceuticals LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761457 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Amneal Pharmaceuticals LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761481 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Teva Pharmaceuticals, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761481 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-09-25 | — | Teva Pharmaceuticals, 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 |
|---|---|---|---|---|---|---|
| 761362 / 002 | Sandoz Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-03-05 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761392 / 002 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-02-13 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761404 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-02-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761398 / 002 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-25 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761398 / 003 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-25 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761444 / 003 | Shanghai Henlius Biotech, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-08-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761436 / 002 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-09-16 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761439 / 002 | Hikma Pharmaceuticals USA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-09-26 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761424 / 002 | Accord BioPharma Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-10-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761457 / 001 | Amneal Pharmaceuticals LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-12-19 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761481 / 001 | Teva Pharmaceuticals, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-09-25 | 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.