Inclunox

Enoxaparin sodium biosimilar developed by Sandoz. Reference product Clexane (Lovenox in the United States).

Brands by market: Inclunox (Canada) · Commercial partner or holder: Sandoz

FDAnot listed

EMAnot listed

PMDAnot listed

HCNov 2020approved

CDSCOnot listed

EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

PMDA

Japan

Not listed by PMDA.

Canada · Inclunox

Health CanadaApproved

Brand

Inclunox

Holder or applicant

Sandoz Canada Incorporated

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Nov 2020

Application or permission

DIN 02507501, 02507528, 02507536, 02507544, 02507552, 02507560, 02507579

Presentations

100, 30, 40, 60, 80 mg; 120, 150 mg

Note

Also Inclunox Hp.

Source

S022

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Chronology

HCNov 2020Notice of Compliance, Health Canada

Sources

S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)

All enoxaparin sodium biosimilars

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Data current to September 2026.