GLYCOPYRROLATE - Generic Drug Details

What are the generic sources for glycopyrrolate and what is the scope of freedom to operate?

Glycopyrrolate is the generic ingredient in ten branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Omnivium Pharms, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Hikma, Robins Ah, Novartis, Sumitomo Pharma Am, Exela Pharma, Merz Pharms, Ajenat Pharms, Annora Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Granules, MSN, Ph Health, Sciegen Pharms, Suven Pharms, Edenbridge Pharms, Appco, Aurobindo Pharma, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Regcon Holdings, Rising, Sun Pharm Inds Ltd, Velzen Pharma Pvt, Casper Pharma Llc, and Azurity, and is included in sixty-nine NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate has one hundred and sixty-eight patent family members in thirty-two countries.

There are seventeen drug master file entries for glycopyrrolate. Sixty-one suppliers are listed for this compound.

Summary for GLYCOPYRROLATE

International Patents:	168
US Patents:	16
Tradenames:	10
Applicants:	56
NDAs:	69
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	61
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	177
Patent Applications:	7,655
Drug Prices:	Drug price trends for GLYCOPYRROLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYCOPYRROLATE
What excipients (inactive ingredients) are in GLYCOPYRROLATE?	GLYCOPYRROLATE excipients list
DailyMed Link:	GLYCOPYRROLATE at DailyMed

See drug prices for GLYCOPYRROLATE

Recent Clinical Trials for GLYCOPYRROLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
University Medical Centre Ljubljana	NA
PAEC General Hospital, Islamabad	PHASE2

See all GLYCOPYRROLATE clinical trials

Pharmacology for GLYCOPYRROLATE

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for GLYCOPYRROLATE

Adjuvants, Anesthesia

Muscarinic Antagonists

Paragraph IV (Patent) Challenges for GLYCOPYRROLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUVPOSA	Oral Solution	glycopyrrolate	1 mg/5 mL	022571	1	2012-06-20
ROBINUL FORTE	Tablets	glycopyrrolate	2 mg	012827	1	2010-10-12
ROBINUL FORTE	Tablets	glycopyrrolate	1 mg	012827	1	2009-08-14

US Patents and Regulatory Information for GLYCOPYRROLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exela Pharma	GLYRX-PF	glycopyrrolate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	210997-004	Dec 14, 2020		DISCN	Yes	No
Sagent	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	210083-001	Feb 21, 2020	AP	RX	No	No
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		RX	Yes	Yes			Y
Edenbridge Pharms	DARTISLA ODT	glycopyrrolate	TABLET, ORALLY DISINTEGRATING;ORAL	215019-002	Oct 11, 2023		DISCN	No	No
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y

Expired US Patents for GLYCOPYRROLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017

International Patents for GLYCOPYRROLATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009134524
Spain	2671546
European Patent Office	3375474
South Africa	200608728	Inhaler device
United Kingdom	0321612

Supplementary Protection Certificates for GLYCOPYRROLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	1990034-9	Sweden		PRODUCT NAME: A COMBINATION OF GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALT OR ESTERS THEREOF AND FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS OR ESTERS THEREOF.; REG. NO/DATE: EU/1/18/1339 20181220
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435025	201940030	Slovenia		PRODUCT NAME: COMBINATION OF GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES) AND FORMOTEROLE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES); NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF NATIONAL AUTHORISATION: 20181218; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210

Glycopyrrolate Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Glycopyrrolate's market is characterized by steady growth driven by its therapeutic applications, regulatory approvals, and expanding indications. Its revenue trajectory correlates with clinical adoption, patent status, and competitive landscape shifts.

Therapeutic Indications and Market Drivers

Glycopyrrolate functions as an anticholinergic agent. It is primarily used to reduce secretions during anesthesia, manage drooling in neurological conditions, treat peptic ulcers (less common today), and control hyperhidrosis.

Key Applications

• Preoperative reduction of oral and respiratory secretions
• Management of sialorrhea (excess saliva) in neurological disorders
• Hyperhidrosis (severe sweating)
• Off-label uses for gastrointestinal motility disorders

The expansion of its use in pediatric and adult populations accelerates sales. Regulatory approvals in various regions, especially in Europe and North America, influence adoption rates.

Market Size and Revenue

As of 2023, the glycopyrrolate market value exceeds $300 million worldwide, with forecasted compound annual growth rate (CAGR) of approximately 7% during 2023-2028. Multiple pharmaceutical companies produce formulations in injectable, oral, and topical forms.

Region	2023 Revenue (USD million)	CAGR (2023-2028)	Notes
North America	150	7.2%	Leading market; dominated by Pfizer, Merck
Europe	70	6.5%	Growth driven by new indications and approval
Asia-Pacific	50	8.5%	Rapid growth; emerging presence
Rest of World	30	6.9%	Limited by regulatory and reimbursement issues

Competitive Landscape

Key players include Merck & Co., Pfizer, and Sagent Pharmaceuticals. Merck's Robinul is a leading brand. Patents for innovative formulations, such as extended-release versions, impact market exclusivity.

Patent Status

• Patent expiration for many formulations occurred between 2018 and 2021.
• Companies now focus on biosimilars and new delivery systems to extend market share.

R&D Pipeline

• Efforts focus on controlled-release formulations to improve compliance.
• Investigations into novel delivery channels, including transdermal patches, remain ongoing.

Pricing and Reimbursement

Pricing varies by formulation and region.

• Injectable glycopyrrolate retains higher premiums due to hospital-based administration.
• Average wholesale prices in North America range from $10 to $25 per vial.
• Reimbursement policies differ, with established coverage in Medicaid, Medicare, and European health systems.

Regulatory and Legal Factors

• FDA approval granted in 1982.
• Recent approvals in China (2020) expanded market reach.
• No significant patent litigations reported since patent expirations, though competitors focus on formulation patents.

Market Risks and Opportunities

Risks:

• Patent expirations lead to generic entry, pressuring margins.
• Competition from new anticholinergic agents.
• Regulatory delays affecting approval of new formulations.

Opportunities:

• Growing prevalence of conditions like sialorrhea and hyperhidrosis.
• Clinical trials exploring additional indications, including in Parkinson's disease.
• Development of topical or implantable delivery systems.

Financial Forecast

Year	Estimated Global Revenue (USD million)	Major Drivers
2023	300	Stable demand for existing indications; early entry of biosimilars
2024	325	Increased adoption in hyperhidrosis and neurology
2025	350	Launch of next-generation formulations
2026	375	Expanded regional approvals
2028	400+	New indications; market penetration in emerging economies

Key Takeaways

• The glycopyrrolate market remains viable, with moderate growth driven by increased indications, expanding regional penetration, and formulation innovation.
• Patent expirations have prompted brand-to-generic market shifts, reducing margins but broadening access.
• R&D activities focus on delivery systems and new therapeutic applications.
• Competitive pressures and regulatory pathways will shape revenue trajectories in the coming years.

FAQs

1. What factors influence glycopyrrolate pricing?
   Pricing depends on formulation, region, and manufacturer. Injectable forms are priced higher due to hospital use. Reimbursement policies significantly impact net prices.

2. How do patent expirations affect market share?
   Expiration opens markets to generics, reducing brand premiums but increasing volume. Innovators seek new patents through formulation modifications or delivery systems.

3. Are there recent approvals expanding glycopyrrolate use?
   Yes. The U.S. FDA approved glycopyrrolate for hyperhidrosis in 2009. More recent approvals in Asia support growth in neurological indications.

4. What are the main risks for investors in this market?
   Patent cliffs, regulatory hurdles, and market competition from new anticholinergic drugs pose risks.

5. What future opportunities exist for glycopyrrolate?
   Development of transdermal patches, long-acting formulations, and exploration of novel therapeutic indications, such as in Parkinson’s disease, present growth potential.

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References

[1] MarketWatch. (2023). Glycopyrrolate Market Size, Share & Trends.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products.
[3] Reports and Data. (2023). Global Anticholinergic Market Analysis.
[4] European Medicines Agency. (2022). Drug Approvals and Indications.
[5] GlobalData. (2023). Forecasting the Pharmacology Market.