Drug

Enoxaparin sodium

As of the edition of 20 October 2026, Enoxaparin sodium is an oligosaccharide: marketed, first approved in 1987 (FR); acts on SERPINC1.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2009
Kind
Oligosaccharide
Brand name
Lovenox (preservative Free)
First approved
3 April 1987 (FR)
Approvals on record
40 in 6 regions
Holder of the most recent approval
FARMA VISION IMPORTAÇÃO E EXPORTAÇÃO DE MEDICAMENTOS LTDA; 11 holders in all
Withdrawn from market
15 September 2019 (in some regions)
Registered trials
184, 26 stopped early
Disease areas
Heart and blood vessels; Lungs and airways; Cancer; Infections; Urinary and reproductive; Blood and lymph

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

3 companies on route B because of this drug.

Companies on route B for this drug

In the product

3 companies are on route B because of Enoxaparin sodium.

Target

GeneProteinUniProt
SERPINC1Antithrombin-IIIP01008

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated362035
Phase 1151500
Phase 2342335
Phase 35430610
Phase 4452576
All trials184

Who has held its approvals

CompanyRoleYears
SanofiApplicant and Lead sponsor of trials1988 to now
Blau FarmaceuticaApplicant2009 to now
Eurofarma LaboratoriosLater holder and Lead sponsor of trials2009 to now
Cristália Produtos Químicos Farmacêuticos LtdaLater holder and Lead sponsor of trials2009 to now
Aché Laboratórios FarmacêuticosLater holder2021 to now
Baxter HealthcareApplicant2023 to now