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LOVENOX (PRESERVATIVE FREE)

NDA

ENOXAPARIN SODIUM | N020164 | SANOFI AVENTIS US LLC

9 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Momenta Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals Industries Ltd. et al 1:2010cv12079 2 patentsANDA 77857enoxaparin sodium	D. Mass.	2010-12-02	Terminated 2016-03-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Aventis Pharmaceuticals, Inc., (Covington & Burling, LLP) - Citizen Petition FDA-2003-P-0273 · 17 docket documents Aventis Pharmaceuticals, Inc., filed this citizen petition on February 19, 2003, requesting that the FDA withhold approval of any abbreviated new drug application (ANDA) for a generic version of Lovenox (enoxaparin sodium injection) unless the generic manufacturer either uses an equivalent manufactu	505(q) Stay Request	2009-04-02	Denied	—
Anil K. Mandal, M.D. - Citizen Petition FDA-2007-P-0339 · 4 docket documents Anil K. Mandal, MD, a consultant nephrologist, filed this citizen petition on August 13, 2007, requesting that the FDA prohibit the use of enoxaparin sodium (Lovenox), a low molecular weight heparin, in patients with acute or chronic renal failure and in elderly subjects over 65 years of age due to	Other	2008-04-25	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

227 trials from ClinicalTrials.gov — 3 recruiting, 163 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology NCT03244020	Phase 4	By Invitation	Massachusetts General Hospital	2,868	2018-02-16 → 2028-07-01
Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients NCT03083184	Phase 3	Recruiting	University Hospital, Clermont-Ferrand	400	2018-02-09 → 2027-12
Anticoagulation-free VV ECMO for Acute Respiratory Failure NCT04273607	Phase 2/3	Recruiting	Damian Ratano	40	2022-09-01 → 2027-01-30
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement NCT03088358	Phase 2	Completed	TeaRx LLC	200	2013-08 → 2015-09
Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®NCT02444572	Phase 4	Completed	Les Laboratoires des Médicaments Stériles	168	2015-10 → 2020-07-10
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty NCT03276143	Phase 2	Completed	Bayer	813	2017-09-21 → 2019-01-02
PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)NCT00077805	Phase 4	Completed	Sanofi	—	2003-08
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients NCT02412982	Phase 4	Completed	University of Cincinnati	103	2016-03 → 2019-01
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery NCT00168805	Phase 3	Completed	Boehringer Ingelheim	2,101	2004-11
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery NCT00306254	Phase 2	Completed	Pfizer	1,225	2006-03 → 2007-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 17 NDCs (2 brand, 15 generic)

Highest NADAC/Unit

$11.81

per ml

Lowest NADAC/Unit

$6.78

per ml

Brand NDCs

Generic NDCs

Avg Brand: $6.78

Avg Generic: $8.52

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00955101210ENOXAPARIN 120 MG/0.8 ML SYR	$11.81	ML	Generic	—	2026-06-17
00955101510ENOXAPARIN 150 MG/ML SYRINGE	$10.63	ML	Generic	—	2026-06-17
63323053903ENOXAPARIN 300 MG/3 ML VIAL	$9.88	ML	Generic	—	2026-06-17
00955101601ENOXAPARIN 300 MG/3 ML VIAL	$9.88	ML	Generic	—	2026-06-17
63323053383ENOXAPARIN 30 MG/0.3 ML SYR	$9.62	ML	Generic	—	2026-06-17
00955100410ENOXAPARIN 40 MG/0.4 ML SYR	$8.06	ML	Generic	—	2026-06-17

Showing 6 of 17 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 28 NDCs (14 FSS, 14 Big4)

Lowest Price

$14.76

Highest Price

$114.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00955-1004-10ENOXAPARIN NA 40MG/0.4ML INJ,SYRINGE,0.4ML	$24.12	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00955-1004-10ENOXAPARIN NA 40MG/0.4ML INJ,SYRINGE,0.4ML	$14.76	Big4	Sanofi Aventis U.S. LLC	05/31/2028
00955-1006-10ENOXAPARIN NA 60MG/0.6ML INJ,SYRINGE,0.6ML	$33.67	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00955-1006-10ENOXAPARIN NA 60MG/0.6ML INJ,SYRINGE,0.6ML	$25.85	Big4	Sanofi Aventis U.S. LLC	05/31/2028
00955-1008-10ENOXAPARIN NA 80MG/0.8ML INJ,SYRINGE,0.8ML	$45.23	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00955-1008-10ENOXAPARIN NA 80MG/0.8ML INJ,SYRINGE,0.8ML	$28.32	Big4	Sanofi Aventis U.S. LLC	05/31/2028

Showing 6 of 28 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Enoxaparin Sodium (2024)

Total Spending

$79.5M

Total Claims

532,949

Beneficiaries

282,561

Avg Cost/Unit

$12.25

Spending Trend

$145.5M(2019)→$116.8M(2020)→$102.0M(2021)→$97.5M(2022)→$95.2M(2023)→$79.5M(2024)

YoY Change:-17.2%

5yr CAGR:-10.6%

Lovenox (2024)

Total Spending

$577K

Total Claims

950

Beneficiaries

392

Avg Cost/Unit

$24.80

Spending Trend

$5.1M(2019)→$3.5M(2020)→$2.8M(2021)→$1.8M(2022)→$676K(2023)→$577K(2024)

YoY Change:-4.8%

5yr CAGR:-21.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Enoxaparin Sodium (2024)

Total Spending

$45K

Total Claims

1,679

Beneficiaries

822

ASP Price

$0.61

Spending Trend

$139K(2019)→$91K(2020)→$68K(2021)→$80K(2022)→$90K(2023)→$45K(2024)

YoY Change:-36.3%

5yr CAGR:+1.1%

HCPCS: J1650 — Injection, enoxaparin sodium, 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain14 active DMFs2 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

DONGYING TIANDONG PHARMACEUTICAL CO LTDENOXAPARIN SODIUM (NON-STERILE BULK FORM)

DMF 184522005

CELSUS LABORATORIES INCENOXAPARIN SODIUM

DMF 217982008

HANGZHOU JIUYUAN GENE ENGINEERING CO LTDENOXAPARIN SODIUM

DMF 252422011

HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTDENOXAPARIN SODIUM

DMF 262582012

SHENZHEN TECHDOW PHARMACEUTICAL CO LTDENOXAPARIN SODIUM USP

DMF 268912013

EMCURE PHARMACEUTICALS LTDENOXAPARIN SODIUM USP

DMF 269472013

SHANDONG CHENZHONG BIOPHARMACEUTICAL CO LTDENOXAPARIN SODIUM USP

DMF 286652014

YANTAI DONGCHENG BIOCHEMICALS CO LTDENOXAPARIN SODIUM USP

DMF 313442017

HUBEI ENORAY BIOPHARMACEUTICAL CO LTDENOXAPARIN SODIUM USP

DMF 320212017

SHENZHEN TECHDOW PHARMACEUTICAL CO LTDENOXAPARIN SODIUM USP

DMF 327442018

HELIOS LIFESCIENCES LTDENOXAPARIN SODIUM USP

DMF 330912018

NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTDENOXAPARIN SODIUM USP

DMF 348272020

APITORIA PHARMA PRIVATE LTDENOXAPARIN SODIUM USP

DMF 413272025

DEFT ORGANICS LIMITEDENOXAPARIN SODIUM USP

DMF 416252025

OPOCRIN SPAInactiveENOXAPARIN SODIUM

DMF 167482003

YANTAI DONGCHENG BIOCHEMICALS CO LTDInactiveENOXAPARIN SODIUM

DMF 243162010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

34 letters from Drugs@FDA

Date	Submission	Document
Jul 31, 2023	SUPPL -101	View Letter (PDF)
Dec 2, 2022	SUPPL -131	View Letter (PDF)
Dec 21, 2021	SUPPL -129	View Letter (PDF)
Dec 20, 2018	SUPPL -116	View Letter (PDF)
Oct 31, 2017	SUPPL -110	View Letter (PDF)
Oct 25, 2013	SUPPL -102	View Letter (PDF)
Jun 7, 2013	SUPPL -100	View Letter (PDF)
Apr 22, 2011	SUPPL -93	View Letter (PDF)
Apr 15, 2011	SUPPL -92	View Letter (PDF)
Dec 31, 2009	SUPPL -85	View Letter (PDF)
Jul 31, 2009	SUPPL -83	View Letter (PDF)
Jul 18, 2008	SUPPL -80	View Letter (PDF)
May 29, 2007	SUPPL -75	View Letter (PDF)
Jan 16, 2007	SUPPL -70	View Letter (PDF)
Mar 10, 2005	SUPPL -63	View Letter (PDF)
Oct 26, 2004	SUPPL -53	View Letter (PDF)
Jul 28, 2004	SUPPL -55	View Letter (PDF)
Jun 8, 2004	SUPPL -10	View Letter (PDF)
May 26, 2004	SUPPL -57	View Letter (PDF)
Apr 29, 2004	SUPPL -58	View Letter (PDF)
Apr 20, 2004	SUPPL -56	View Letter (PDF)
Feb 25, 2004	ORIG -1	View Letter (PDF)
Dec 23, 2003	SUPPL -48	View Letter (PDF)
Jul 8, 2003	SUPPL -50	View Letter (PDF)
Jul 6, 2003	SUPPL -51	View Letter (PDF)
Jan 23, 2003	SUPPL -43	View Letter (PDF)
Jan 9, 2002	SUPPL -46	View Letter (PDF)
Jan 9, 2002	SUPPL -40	View Letter (PDF)
Jan 9, 2002	SUPPL -45	View Letter (PDF)
Nov 17, 2000	SUPPL -37	View Letter (PDF)
Nov 17, 2000	SUPPL -36	View Letter (PDF)
Sep 27, 2000	SUPPL -34	View Letter (PDF)
Aug 4, 2000	SUPPL -20	View Letter (PDF)
Dec 31, 1998	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (9)

Sort:

#009 — 300MG/3ML (100MG/ML)

RLDAB

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Jan 23, 2003

#001 — 30MG/0.3ML (100MG/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Mar 29, 1993

No patent or exclusivity listings for this strength.

#002 — 40MG/0.4ML (100MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Jan 30, 1998

#003 — 60MG/0.6ML (100MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Mar 27, 1998

#004 — 80MG/0.8ML (100MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Mar 27, 1998

#005 — 100MG/ML (100MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Mar 27, 1998

#006 — 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Jun 2, 2000

#007 — 120MG/0.8ML (150MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Jun 2, 2000

#008 — 150MG/ML (150MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Jun 2, 2000