Viewing data from:

CUVPOSA

NDA

GLYCOPYRROLATE | N022571 | MERZ PHARMACEUTICALS 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

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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Cuvposa (2023)

Total Spending

$267K

Total Claims

553

Beneficiaries

131

Avg Cost/Unit

$1.02

Spending Trend

$2.0M(2019)→$1.5M(2020)→$1.5M(2021)→$641K(2022)→$267K(2023)

YoY Change:-4.3%

5yr CAGR:-2.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs7 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

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

5 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2018	SUPPL -8	View Letter (PDF)
May 20, 2016	SUPPL -6	View Letter (PDF)
Nov 13, 2015	SUPPL -4	View Letter (PDF)
May 23, 2013	SUPPL -3	View Letter (PDF)
Aug 2, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/5ML

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jul 28, 2010

No patent or exclusivity listings for this strength.