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HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

NDA

HEPARIN SODIUM | N019802 | B BRAUN MEDICAL INC

4 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from B. Braun Medical Inc. FDA-2022-P-0060 · 4 docket documents B. Braun Medical Inc. filed this petition under 21 CFR 314.161(b) requesting that the FDA Commissioner determine that four Heparin Sodium in Sodium Chloride Injection products approved under NDA 019802 were not withdrawn for safety or effectiveness reasons, as the petitioner states no such issues ar	Other	2022-01-11	Granted	B. Braun Medical Inc.

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

Clinical Trials

291 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 163 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Reprometabolic Syndrome Mediates Subfertility in Obesity NCT02653092	N/A	Active	University of Colorado, Denver	84	2016-06 → 2026-12-11
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction NCT03537586	N/A	Active	NYU Langone Health	206	2018-06-29 → 2026-06-30
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery NCT03302195	N/A	Recruiting	Laval University	410	2015-08-21 → 2027-12-31
Anticoagulation-free VV ECMO for Acute Respiratory Failure NCT04273607	Phase 2/3	Recruiting	Damian Ratano	40	2022-09-01 → 2027-01-30
Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency NCT04227678	N/A	Recruiting	Université de Sherbrooke	16	2019-12-09 → 2027-03-30
Patients Preference With Self-Injection: The PRISM Study NCT00253396	Phase 4	Completed	Hamilton Health Sciences Corporation	100	2005-10 → 2007-01
Enoxaparin Versus Unfractionated Heparin in PCI NCT00439855	Phase 4	Completed	Triemli Hospital	2,100	2003-09 → 2006-02
Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose NCT00657475	Phase 4	Completed	University Hospital, Bordeaux	238	2008-06 → 2013-03
Efficacy and Safety of Sodium Heparin NCT00894985	Phase 3	Completed	Azidus Brasil	104	2009-06 → 2011-12
Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles NCT01590173	Phase 2/3	Completed	National and Kapodistrian University of Athens	86	2012-01 → 2016-07

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

API Supply Chain25 active DMFs25 inactive

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

SCIENTIFIC PROTEIN LABORATORIES LLCHEPARIN SODIUM USP

DMF 26161976

PFIZER INCHEPARIN SODIUM USP

DMF 27121976

BIOCHEM SIOUX CITY INCHEPARIN SODIUM CRUDE (PORCINE)

DMF 58781985

SMITHFIELD BIOSCIENCE INCHEPARIN SODIUM USP

DMF 79441989

BIOCHEM OSS BVHEPARIN SODIUM USP

DMF 91311991

BIOIBERICA SAUHEPARIN SODIUM

DMF 178382004

SHENZHEN HEPALINK PHARMACEUTICAL GROUP CO LTDHEPARIN SODIUM USP

DMF 178452004

NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTDHEPARIN SODIUM USP

DMF 181282005

YANTAI DONGCHENG BIOCHEMICALS CO LTDHEPARIN SODIUM, INJECTABLE GRADE NON-STERILE BULK DRUG

DMF 183552005

SANDOZ GMBHHEPARIN SODIUM

DMF 185572005

QINGDAO JIULONG BIOPHARMACEUTICAL CO LTDHEPARIN SODIUM USP

DMF 222222008

BIOFER SPAHEPARIN SODIUM

DMF 223482008

DONGYING TIANDONG PHARMACEUTICAL CO LTDHEPARIN SODIUM USP

DMF 226972009

CHANGZHOU QIANHONG BIO PHARMA CO LTDHEPARIN SODIUM USP (NON STERILE BULK)

DMF 229552009

GLAND PHARMA LTDHEPARIN SODIUM USP

DMF 238392010

HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTDHEPARIN SODIUM

DMF 245952011

INTERNATIONAL MEDICATION SYSTEMS LTDHEPARIN SODIUM USP

DMF 260702012

BIOIBERICA SAUHEPARIN SODIUM (PROCESS P024900)

DMF 266802013

SHANDONG CHENZHONG BIOPHARMACEUTICAL CO LTDHEPARIN SODIUM

DMF 293532015

HUBEI ENORAY BIOPHARMACEUTICAL CO LTDHEPARIN SODIUM USP

DMF 300292016

HUBEI ENORAY BIOPHARMACEUTICAL CO LTDHEPARIN SODIUM CRUDE

DMF 304772017

BIOIBERICA SAUHEPARIN SODIUM (PROCESS MPHP22002)

DMF 317382017

AKRON BIOTECHNOLOGY LLCHEPARIN SODIUM

DMF 348602020

BIOCHEM OSS BVHEPARIN SODIUM PORCINE

DMF 362912021

SHANDONG SHEELIAN PHARMACEUTICAL CO LTDHEPARIN SODIUM

DMF 431992026

SYNTEX LABSInactiveHEPARIN, SODIUM

DMF 24401975

INORP SAInactiveHEPARIN SODIUM

DMF 24591975

PROQUIMIO LTDInactiveHEPARIN

DMF 24651975

WEDDEL PHARMS LTDInactiveHEPARIN SODIUM USP

DMF 27171976

BACON AND THOMASInactiveHEPARIN SODIUM

DMF 27691976

DIOSYNTH INCInactiveHEPARIN SODIUM USP (BEEF LUNG)

DMF 37531980

DIOSYNTH INCInactiveHEPARIN SODIUM (CRUDE) FROM BEEF LUNGS

DMF 40701981

DIOSYNTH BVInactiveHEPARIN SODIUM

DMF 40771981

MEDIMPEX NORTH AMERICA INCInactiveHEPARIN SODIUM

DMF 48651982

SANOFI CHIMIEInactiveHEPARIN SODIUM

DMF 94721991

SYNTEX SAInactiveHEPARIN SODIUM

DMF 96201992

DIOSYNTH BVInactiveHEPARIN SODIUM

DMF 100521992

LEO PHARMACEUTICAL PRODUCTS LTDInactiveHEPARIN SODIUM DRUG SUBSTANCE

DMF 105891993

SHANGHAI NUMBER 1 BIOCHEMICAL AND PHARMACEUTICAL COInactiveHEPARIN SODIUM

DMF 122811996

LEO PHARMA ASInactiveHEPARIN SODIUM DRUG SUBSTANCE

DMF 140381999

DIOSYNTH BVInactiveHEPARIN SODIUM

DMF 149562000

CELSUS LABORATORIES INCInactiveHEPARIN SODIUM ISOTONIC SOLUTION

DMF 156002001

CHANGZHOU SPL COInactiveHEPARIN SODIUM USP

DMF 159732002

NV ORGANONInactiveHEPARIN SODIUM III

DMF 162342002

CHANGZHOU QIANHONG BIO PHARMA CO LTDInactiveHEPARIN SODIUM USP

DMF 190072005

HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTDInactiveHEPARIN SODIUM USP

DMF 191942006

HUAIAN MDC CHEMISTRY CO LTDInactiveHEPARIN SODIUM (CRUDE)

DMF 209942007

SICHUAN DEEBIO PHARMACEUTICAL CO LTDInactiveHEPARIN SODIUM

DMF 272432013

LABORATORI DERIVATI ORGANICI SPAInactiveHEPARIN SODIUM, USP GRADE

DMF 338512019

ASPEN OSS BVInactiveHEPARIN SODIUM

DMF 346862020

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

Products (4)

Sort:

#001 — 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 20, 1992

No patent or exclusivity listings for this strength.

#002 — 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 20, 1992

#005 — 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 20, 1992

#003 — 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 20, 1992