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OXYTOCIN

NDA

OXYTOCIN | N018248 | FRESENIUS KABI USA 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2757 · 8 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare that Oxytocin Injection, USP (synthetic), 10 USP Units/mL in pharmacy	Suitability	2024-06-10	Denied	Hyman, Phelps & McNamara, P.C.
Alaunus Pharmaceutical, LLC (Patrick Foster) - Citizen Petition FDA-2010-P-0112 · 7 docket documents Alaunus Pharmaceutical LLC, represented by Patrick Foster, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for Oxytocin Injection USP in a 1000 USP Units per 100 mL multiple do	Other	2012-01-27	Denied	—

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

Clinical Trials

316 trials from ClinicalTrials.gov — 4 recruiting, 230 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oxytocin and Fetal Heart Rate Changes NCT03232918	Phase 4	Recruiting	Unyime Ituk	730	2019-02-20 → 2025-12-31
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination NCT04218409	Early Phase 1	Recruiting	University of Florida	45	2021-09-02 → 2026-12-31
The Role of Oxytocin in the Second Stage of Labor NCT04303702	N/A	Recruiting	Washington University School of Medicine	400	2022-07-01 → 2027-09-30
Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine NCT03860233	Phase 1	Recruiting	Vivek Jain	40	2019-03-04 → 2026-12-31
Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies NCT01548521	Phase 1/2	Completed	University Hospital, Toulouse	5	2011-07 → 2012-04
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin NCT02465164	N/A	Completed	Henry Ford Health System	26	2015-07-01 → 2016-07-30
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia NCT01614093	Phase 4	Completed	University of Maryland, Baltimore	24	2012-06 → 2014-01
Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep NCT03148899	Phase 2	Completed	George Washington University	32	2016-07-27 → 2020-06-07
Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section NCT03591679	N/A	Completed	Assiut University	1,070	2017-12-01 → 2019-01-01
Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms NCT03662425	N/A	Completed	Shanghai Mental Health Center	43	2018-07-21 → 2020-03-31

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$60.86

Highest Price

$461.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63323-0012-10OXYTOCIN 10U/ML 10ML MDV	$139.46	FSS	Fresenius Kabi, LLC	05/14/2030
63323-0012-11OXYTOCIN 10U/ML 1ML MDV	$60.86	FSS	Fresenius Kabi, LLC	05/14/2030
63323-0012-30OXYTOCIN 10UNT/ML INJ	$461.14	FSS	Fresenius Kabi, LLC	05/14/2030

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

API Supply Chain7 active DMFs6 inactive

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

ASPEN OSS BVOXYTOCIN

DMF 102941993

JOINT STOCK CO GRINDEKSOXYTOCIN, USP

DMF 217772008

HEMMO PHARMACEUTICALS PVT LTDOXYTOCIN

DMF 265172012

HYBIO PHARMACEUTICAL CO LTDOXYTOCIN NON STERILE BULK DRUG SUBSTANCE

DMF 349162020

SHENZHEN JYMED TECHNOLOGY CO LTDOXYTOCIN

DMF 354322020

PIRAMAL PHARMA LTDOXYTOCIN USP

DMF 376892023

HARBIN JIXIANGLONG BIOTECH CO LTDOXYTOCIN

DMF 399522024

DIOSYNTH BVInactiveOXYTOCIN ACETATE

DMF 38151980

FERRING ABInactiveOXYTOCIN

DMF 38761980

BIOCHEMIC GESELLSCHAFT MBHInactiveOXYTOCIN SOLUTION 200 I.U./ML

DMF 41911981

MEDIMPEX NORTH AMERICA INCInactiveOXYTOCIN

DMF 45511982

BIOCHEMIC GESELLSCHAFT MBHInactiveOXYTOCIN ACETATE LYOPHILIZED

DMF 78881989

CARLBIOTECH LTD ASInactiveOXYTOCIN

DMF 96041992

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 21, 2022	SUPPL -49	View Letter (PDF)
Jul 30, 2007	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10USP UNITS/ML (10USP UNITS/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100USP UNITS/10ML (10USP UNITS/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 300USP UNITS/30ML (10USP UNITS/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 27, 2007