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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients NCT06357403	—	Recruiting	Medical University of Vienna	1,300	2024-05-04 → 2027-08

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

Medicare Part D Spending

CMS annual spending data for Lovenox (2023)

Total Spending

$676K

Total Claims

977

Beneficiaries

390

Avg Cost/Unit

$26.06

Spending Trend

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

YoY Change:-49.5%

5yr CAGR:-12.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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