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NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

NDA

SODIUM NITROPRUSSIDE | N209387 | EXELA PHARMA SCIENCES LLC

3 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 Cardinal Health Regulatory Sciences FDA-2020-P-1678 · 6 docket documents Cardinal Health Regulatory Sciences filed a citizen petition pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Nipride RTU (sodium nitroprusside), 10 mg/50 ml, NDA 209387 held by EXELA PHARMA SCS LLC was voluntarily withdrawn or withheld	505(q)	2020-07-20	Granted	Cardinal Health Regulatory Sciences

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

Clinical Trials

38 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity NCT03318094	Phase 1	Active	Vanderbilt University Medical Center	36	2017-10-24 → 2027-11-30
: Vascular Function in Health and Disease NCT02966665	Phase 1	Recruiting	Russell Richardson	420	2008-09 → 2026-08
Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV NCT02560805	Phase 2	Recruiting	Emory University	134	2015-10 → 2027-03-30
Effect of Sodium Nitroprusside on Cerebral Blood Flow NCT03317652	N/A	Completed	Rigshospitalet, Denmark	20	2017-11-03 → 2017-12-04
Interaction of Apelin and Angiotensin in the Human Forearm Circulation NCT00901888	N/A	Completed	University of Edinburgh	12	2009-04 → 2010-05
The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study NCT02176044	Phase 1	Completed	King's College London	21	2014-08 → 2016-02
Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)NCT00093912	Phase 3	Completed	The Medicines Company	739	2004-06 → 2006-11
Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia NCT01548612	Phase 2	Completed	University of Sao Paulo	20	2006-02 → 2010-12
Nutritional and Contractile Regulation of Muscle Growth NCT00891696	Phase 1	Completed	The University of Texas Medical Branch, Galveston	144	2009-04 → 2015-03
REperfusion Facilitated by LOcal Adjunctive Therapy in ST-elevation Myocardial Infarction NCT01747174	Phase 2	Completed	University Hospitals, Leicester	247	2011-10 → 2014-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$26.39

Highest Price

$45.23

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
51754-1006-01NIPRIDE RTU 50MG/100ML (0.5MG/ML) INJ	$45.23	FSS	Exela Pharma Sciences, LLC	09/28/2029
51754-1006-01NIPRIDE RTU 50MG/100ML (0.5MG/ML) INJ	$33.38	Big4	Exela Pharma Sciences, LLC	09/28/2029
51754-1029-01NIPRIDE RTU 20MG/100ML (0.2MG/ML) INJ	$35.18	FSS	Exela Pharma Sciences, LLC	09/28/2029
51754-1029-01NIPRIDE RTU 20MG/100ML (0.2MG/ML) INJ	$26.39	Big4	Exela Pharma Sciences, LLC	09/28/2029

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

API Supply Chain14 active DMFs1 inactive

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

STERLING PHARMA USA LLCSODIUM NITROPRUSSIDE USP

DMF 274682014

ALCHYMARS ICM SM PRIVATE LTDSODIUM NITROPRUSSIDE USP

DMF 278122013

CHEMCON GMBHSODIUM NITROPRUSSIDE DIHYDRATE

DMF 281602014

MICRO LABS LTDSODIUM NITROPRUSSIDE USP

DMF 291562015

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSODIUM NITROPRUSSIDE

DMF 296472015

EMCURE PHARMACEUTICALS LTDSODIUM NITROPRUSSIDE USP

DMF 296942015

CHEMWERTH INCSODIUM NITROPRUSSIDE

DMF 297232015

AMPHASTAR NANJING PHARMACEUTICALS INCSODIUM NITROPRUSSIDE USP

DMF 298712015

MATRIX PHARMACORP PRIVATE LTDSODIUM NITROPRUSSIDE USP

DMF 308492016

NAVINTA LLCSODIUM NITROPRUSSIDE USP

DMF 311642017

SUN PHARMACEUTICAL INDUSTRIES LTDSODIUM NITROPRUSSIDE USP

DMF 312622017

APITORIA PHARMA PRIVATE LTDSODIUM NITROPRUSSIDE USP

DMF 323932017

HAINAN POLY PHARMACEUTICAL CO LTDSODIUM NITROPRUSSIDE USP

DMF 330232018

ANHUI POLY PHARM CO LTDSODIUM NITROPRUSSIDE USP

DMF 399472024

HOSPIRA BOULDER INCInactiveSODIUM NITROPRUSSIDE

DMF 46921982

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 24, 2018	SUPPL -3	View Letter (PDF)
Mar 14, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG/100ML (0.5MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 8, 2017

No patent or exclusivity listings for this strength.

#002 — 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Dec 7, 2017

#003 — 20MG/100ML (0.2MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 13, 2018