Vyvgart Hytrulo
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
{"sequence":255,"product_key":"US:BLA:761304:001","judgment_status":"PROVISIONAL_EVIDENCE_SCREEN","review_basis":"LATER_RIGHT_SIGNAL","reason_codes":["LATER_PATENT_REFERENCE_DATE: US11591388"],"unknown_patent_terms":[],"pending_publications":[],"regulatory_anchor":"2033-12-17","later_regulatory_events":[],"batch":"BLA-05-06","review_version":"1.1","selection_status":"DEEP_REVIEW","verified":false,"anchor_status":"OPERATIONAL_UNVERIFIED","rights_anchor_date":"2036-03-07","patent_anchor_numbers":["US10316073"],"patent_term_verified":false,"canonical_judgment_confirmed":false,"first_biosimilar_approval_date":null,"first_final_generic_date":null,"has_existing_generic":null,"has_existing_biosimilar":null,"report":"BLA_05_06_50_JUDGMENT_20261021.html","report_sha256":"d3f5cba95e750a9f93f53184cc6d1c82c363bb5bb718ddbc60ccfe5c14efed29","regulatory_update_pending":true,"local_patent_review_pending":true,"FDA_followup":[{"issue":"FDA_RPE_DETERMINATION_AND_END_DATE_NOT_LOCATED","status":"UPDATE_PENDING","reason":"FDA PB target fields remain blank; no additional exact-target final determination located in the retrieved public FDA letters/review/administrative documents. Orange Book has no target BLA rows. Operational baseline retained with verified=false."},{"issue":"FDA_ODE_END_DATE_OR_PROTECTED_SCOPE_NOT_PUBLISHED","status":"UPDATE_PENDING","events":[{"source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=825421","approval_date":"2025-04-10","date_display":"Not Detected","end_date_raw":"TBD"},{"source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=825421","approval_date":"2026-05-08","date_display":"Not Detected","end_date_raw":"TBD"},{"source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=527316","approval_date":"2026-05-08","date_display":"Not Detected","end_date_raw":"TBD"},{"source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=851421","approval_date":"2025-04-10","date_display":"Not Detected","end_date_raw":"TBD Generic Name: efgartigimod alfa and hyaluronidase-qvfc Trade Name: Vyvgart Hytrulo Date Designated: 11/08/2021 Orphan Designation: Treatment of Chronic Inflammatory Demyelinating Polyneuropathy Orphan Designation Status: Designated/Approved Sponsor: argenx BV Industriepark Zwijnaarde 7 Zwijnaarde, East Flanders 9052 Belgium The sponsor address listed is the last reported by the sponsor to OOPD. Marketing approved:"}],"reason":"Refreshed official individual OOPD pages continue to show TBD/no protected scope; no exact award date located in retrieved FDA documents. Search endpoint returned 503."}],"tail_patents":["US11591388"]}
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US10316073 | 2036-03-07 | — — | Y | N | TRUE_DS {"classification":"TRUE_DS","claim_count":10,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"SUPPORTED_BY_PRIMARY_SEQUENCE_OR_STRUCTURE","batch":"BLA-05-06"} | — | — | — |
| US11591388 | 2041-05-06 | — — | N | N | DP_NON_DS {"classification":"DP_NON_DS","claim_count":21,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"} | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE | 2026-05-08 | — | N | N | — | — | Source | |
| ODE | 2025-04-10 | — | N | N | — | — | Source | |
| ODE | 2025-04-10 | — | N | N | — | — | Source | |
| ODE | 2026-05-08 | — | N | N | — | — | Source | |
| ODE | 2021-12-17 | 2028-12-17 | treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive | N | N | — | — | Source |
| ODE | 2023-06-20 | 2030-06-20 | treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive | N | N | — | — | Source |
| ODE | 2024-06-21 | 2031-06-21 | treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | N | N | — | — | Source |
| Orphan Exclusivity Exp. Date | — | 2031-06-21 | — | — | — | — | Source | |
| RPE_BASELINE | 2021-12-17 | 2033-12-17 | Full-product 12-year operational assumption; not FDA determination | Y | Y | — | — | 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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 0 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 |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (10)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2036-03-07 | ANCHOR_REFERENCE | Product scope reviewed; reference date only; current official term verification pending | Source |
| PATENT | 2041-05-06 | OTHER_RIGHT_REFERENCE | Product scope reviewed; reference date only; current official term verification pending | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-12-17 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-06-20 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2031-06-21 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2033-12-17 | SCOPE_HISTORY | User-adopted operational baseline; inherited dates do not restart RPE; not FDA determination | 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.