Product profile · United States
Rituxan
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2009. Anchor type: EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2009-11-26. Anchor date: 2009-11-26. 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 |
|---|---|---|---|---|---|---|---|---|
| 7485704 | 2025-03-08 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 7976838 | 2025-06-30 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10450379 | 2026-11-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10654940 | 2026-11-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10759866 | 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. | — | — | — |
| 8460895 | 2029-08-08 | 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. | — | — | — |
| 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. | — | — | — |
| 10017732 | 2034-03-14 | 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. | — | — | — |
| 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 | — | 2028-12-02 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 761088 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2018-11-28 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761088 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2018-11-28 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761103 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-07-23 | — | Pfizer Ireland Pharmaceuticals Unlimited Company | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761103 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-07-23 | — | Pfizer Ireland Pharmaceuticals Unlimited Company | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761140 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-12-17 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761140 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-12-17 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761088 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761088 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761376 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-07-31 | — | Dr. Reddy's Laboratories SA | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761376 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-07-31 | — | Dr. Reddy's Laboratories SA | 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 8 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 |
|---|---|---|---|---|---|---|
| 761088 / 001 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2018-11-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761088 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2018-11-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761103 / 001 | Pfizer Ireland Pharmaceuticals Unlimited Company | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-07-23 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761103 / 002 | Pfizer Ireland Pharmaceuticals Unlimited Company | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2019-07-23 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761140 / 001 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-12-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761140 / 002 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2020-12-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761376 / 001 | Dr. Reddy's Laboratories SA | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-07-31 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761376 / 002 | Dr. Reddy's Laboratories SA | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-07-31 | 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.