Product profile · United States

Sylvant

· Patent Litigation & Settlement History ↓

Ingredientsiltuximab

Application typeBLA

Application125496

Product002

Dosage formFor Injection

RouteIntravenous

Strength400MG

Approval date2014-04-23

Marketing statusPrescription

Status event—

ApplicantRECORDATI RARE DISEASES, INC.

Product source

Current GenericRadar decision

Year2026

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeEXCLUSIVITY

Anchor date2026-04-23

Patent anchor2022-10-26

Exclusivity anchor2026-04-23

Protection date—

First Final ANDA—

Status event—

BLA-05-02/9: Sylvant 400MG; 2026 DEEP_REVIEW; anchor=2026-04-23 (EXCLUSIVITY). Flags: RPE_OPERATIONAL_NOT_FDA_DETERMINATION; EXACT_FINAL_ANDA_NOT_SEPARATELY_RECHECKED;NO_DISQUALIFICATION_FROM_INDIRECT_BIOSIMILAR. Final operational judgment adopted; no verified=1 promotion. Update when evidence is found.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
No patent facts are recorded for this product.

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
Orphan Exclusivity Exp. Date	—	2021-04-23		—	—	—	—	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 (1)

Type	Date	Role	Basis	Source
BLA_PATENT_EXCLUSIVITY_REVIEW	—	BUSINESS_CLASSIFICATION_WITH_CONDITIONS	BLA-05-02/9: Sylvant 400MG; 2026 DEEP_REVIEW; anchor=2026-04-23 (EXCLUSIVITY). Flags: RPE_OPERATIONAL_NOT_FDA_DETERMINATION; EXACT_FINAL_ANDA_NOT_SEPARATELY_RECHECKED;NO_DISQUALIFICATION_FROM_INDIRECT_BIOSIMILAR. Final operational judgment adopted; no verified=1 promotion. Update when evidence is found.	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.