Viewing data from:

GLYCOPYRROLATE

ANDA

GLYCOPYRROLATE | A204438 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CUVPOSA(TE code: AA)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Merz Pharmaceuticals LLC v. Par Pharmaceutical Inc. et al 1:2012cv01723 2 patentsANDA 204438glycopyrrolate	D. Del.	2012-12-17	Terminated 2013-11-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.1752

per ml

Lowest NADAC/Unit

$0.1752

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49884004233GLYCOPYRROLATE 1 MG/5 ML ORAL SOLUTION	$0.1752	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$304.67

Highest Price

$304.67

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49884-0042-33GLYCOPYRROLATE 1MG/5ML SOLN,ORAL	$304.67	FSS	Golden State Medical Supply, Inc.	06/14/2028

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

1 letter from Drugs@FDA

Date	Submission	Document
Sep 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Aug 9, 2021

No patent or exclusivity listings for this strength.