Product profile · United States

Epkinly

· Patent Litigation & Settlement History ↓

Ingredientepcoritamab-bysp

Application typeBLA

Application761324

Product001

Dosage formInjection

RouteSubcutaneous

Strength4MG/0.8ML

Approval date2023-05-19

Marketing statusPrescription

Status event—

ApplicantGENMAB US, INC.

Product source

Current GenericRadar decision

Year2035

SelectionDEEP_REVIEW

ReviewFINAL_CHECKING

Anchor typeDRUG_SUBSTANCE

Anchor date2035-10-22

Patent anchor2035-10-22

Exclusivity anchor2035-05-19

Protection date—

First Final ANDA—

Status event—

{"sequence":251,"product_key":"US:BLA:761324:001","judgment_status":"PROVISIONAL_EVIDENCE_SCREEN","review_basis":"INCOMPLETE_EVIDENCE_ONLY","reason_codes":["PATENT_TERM_NOT_LOCATED: US10544220"],"unknown_patent_terms":["US10544220"],"pending_publications":[],"regulatory_anchor":"2035-05-19","later_regulatory_events":[],"batch":"BLA-05-06","review_version":"1.1","selection_status":"DEEP_REVIEW","verified":false,"anchor_status":"OPERATIONAL_UNVERIFIED","rights_anchor_date":"2035-10-22","patent_anchor_numbers":["US10465006"],"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=865921","approval_date":"2025-11-18","date_display":"Not Detected","end_date_raw":"TBD"}],"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":[]}

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
US10544220	—	— —	Y	N	TRUE_DS {"classification":"TRUE_DS","claim_count":12,"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"}	—	—	—
US10465006	2035-10-22	— —	Y	N	TRUE_DS {"classification":"TRUE_DS","claim_count":19,"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"}	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
ODE	2025-11-18	—		N	N	—	—	Source
ODE	2024-06-26	2031-06-26	treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy	N	N	—	—	Source
Orphan Exclusivity Exp. Date	—	2031-06-26		—	—	—	—	Source
RPE_BASELINE	2023-05-19	2035-05-19	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 (5)

Type	Date	Role	Basis	Source
PATENT	—	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2035-10-22	ANCHOR_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	2031-06-26	SCOPE_HISTORY	Indication-specific history; full coverage not asserted	Source
REGULATORY_EXCLUSIVITY	2035-05-19	SCOPE_HISTORY	User-adopted operational baseline; inherited dates do not restart RPE; not FDA determination	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.