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GLYCOPYRROLATE

NDA

GLYCOPYRROLATE | N214919 | FRESENIUS KABI USA LLC

1 strength0 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 Fresenius Kabi USA LLC FDA-2022-P-1656 · 3 docket documents Fresenius Kabi USA, LLC filed this citizen petition pursuant to 21 CFR 10.30 requesting that the FDA designate its Glycopyrrolate Injection, USP approved under 505(b)(2) NDA 214919 as therapeutically equivalent with an 'AP' rating to the reference listed drug Robinul® (NDA 017558) by Hikma Pharmaceu	Other	2022-07-22	Denied	Fresenius Kabi USA LLC

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

Clinical Trials

77 trials from ClinicalTrials.gov, 64 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)NCT03909165	Phase 4	Completed	Merck Sharp & Dohme LLC	145	2019-07-23 → 2023-09-21
Chronotropic Incompetence in Patients With HFpEF NCT02524145	N/A	Completed	University of Texas Southwestern Medical Center	40	2015-06 → 2017-11-15
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration NCT01176903	Phase 1/2	Completed	Chiesi Farmaceutici S.p.A.	65	2010-08 → 2011-08
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions NCT00491894	Phase 3	Completed	Shionogi	137	2007-03 → 2008-06
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT00570778	Phase 2	Completed	Novartis Pharmaceuticals	154	2007-12 → 2008-09
Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery.NCT02996591	Phase 4	Completed	Hospital for Special Surgery, New York	36	2017-01 → 2017-05
The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD NCT03081156	Phase 4	Completed	William Stringer, md	52	2017-03-27 → 2019-01-31
Sugammadex and Brain Waves NCT01142648	Phase 4	Completed	Tampere University Hospital	30	2009-04 → 2010-03
Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)NCT03346070	Phase 4	Completed	Merck Sharp & Dohme LLC	207	2018-01-01 → 2019-01-29
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine NCT02430272	N/A	Completed	Inje University	84	2014-05 → 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

$5.96

Highest Price

$93.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
76045-0023-30GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,3ML	$90.35	FSS	Fresenius Kabi, LLC	05/14/2030
76045-0023-30GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,3ML	$5.96	Big4	Fresenius Kabi, LLC	05/14/2030
76045-0223-30GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,3ML	$93.37	FSS	Fresenius Kabi, LLC	05/14/2030
76045-0223-30GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,3ML	$93.37	Big4	Fresenius Kabi, LLC	05/14/2030

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

API Supply Chain16 active DMFs8 inactive

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

AMSA SPAGLYCOPYRROLATE

DMF 169722003

PCASGLYCOPYRROLATE

DMF 181062005

HIKMA PHARMACEUTICALS LLCGLYCOPYRROLATE USP

DMF 187272005

AKSHAT PHARMA PRIVATE LTDGLYCOPYRROLATE USP

DMF 190262005

HARMAN FINOCHEM LTDGLYCOPYRROLATE USP

DMF 197102006

TAI HENG INDUSTRY CO LTDGLYCOPYRROLATE USP

DMF 213262008

RESONANCE LABORATORIES PVT LTDGLYCOPYRROLATE

DMF 264702012

COHANCE LIFESCIENCES LTDGLYCOPYRROLATE USP

DMF 300612015

INKE SAGLYCOPYRROLATE

DMF 318362017

NISHCHEM INTERNATIONAL PRIVATE LTDGLYCOPYRROLATE USP

DMF 338062019

HARMAN FINOCHEM LTDGLYCOPYRROLATE TOSYLATE

DMF 341112019

HAINAN POLY PHARM CO LTDGLYCOPYRROLATE

DMF 354462021

MELODY HEALTHCARE PVT LTDGLYCOPYRROLATE USP

DMF 376482022

SWATI SPENTOSE PRIVATE LTDGLYCOPYRROLATE USP

DMF 385502023

VIYASH LIFE SCIENCES PRIVATE LTDGLYCOPYRROLATE

DMF 393372024

CIPLA LTDGLYCOPYRROLATE USP

DMF 423312025

SB PENICK AND COInactiveGLYCOPYRROLATE

DMF 4301961

LEIRAS OYInactiveGLYCOPYRROLATE, USP

DMF 35221979

BOEHRINGER INGELHEIM CHEMICALS INCInactiveGLYCOPYRROLATE

DMF 60441985

BOCA PHARMACAL LLCInactiveGLYCOPYRROLATE USP

DMF 205782007

BIOFIRST PHARMACEUTICALS LLCInactiveGLYCOPYRROLATE

DMF 206882007

AUROBINDO PHARMA LTDInactiveGLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE

DMF 207662007

CERBIOS PHARMA SAInactiveGLYCOPYRROLATE USP

DMF 293312017

HOVIONE PHARMASCIENCE LTDInactiveGLYCOPYRROLATE INHALATION GRADE

DMF 312062016

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 17, 2025	SUPPL -2	View Letter (PDF)
Apr 22, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.6MG/3ML (0.2MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Apr 21, 2022

No patent or exclusivity listings for this strength.