Herceptin
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DISCONTINUED. Reference year: 2021. Anchor type: PRODUCT_STATUS. Patent anchor: not recorded. Exclusivity anchor: not recorded. Anchor date: 2021-02-03. 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 |
|---|---|---|---|---|---|---|---|---|
| 10808037 | 2028-07-08 | 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. | — | — | — |
| 10662237 | 2031-08-07 | 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 | — | 2017-10-20 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 761074 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2017-12-01 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761091 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2018-12-14 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761100 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-01-18 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761081 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-03-11 | — | Pfizer Ireland Pharmaceuticals Unlimited Company | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761074 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-04-17 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761091 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-05-16 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761073 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-06-13 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761073 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-10-25 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761100 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-03-20 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761081 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-11-30 | — | Pfizer Ireland Pharmaceuticals Unlimited Company | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761346 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-04-25 | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761346 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-06 | — | Accord BioPharma 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 12 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 |
|---|---|---|---|---|---|---|
| 761074 / 001 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2017-12-01 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761091 / 001 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2018-12-14 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761100 / 001 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-01-18 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761081 / 001 | Pfizer Ireland Pharmaceuticals Unlimited Company | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-03-11 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761074 / 002 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-04-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761091 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-05-16 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761073 / 001 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-06-13 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761073 / 002 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-10-25 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761100 / 002 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-03-20 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761081 / 002 | Pfizer Ireland Pharmaceuticals Unlimited Company | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-11-30 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761346 / 001 | Accord BioPharma Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-04-25 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761346 / 002 | Accord BioPharma Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-06 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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.