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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2757 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	Open	Hyman

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs6 inactive

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

ASPEN OSS BVOXYTOCIN

DMF 102941993

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