Glycopyrrolate - Generic Drug Details

What are the generic drug sources for glycopyrrolate and what is the scope of patent protection?

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, Chartwell Rx, Granules, MSN, Ph Health, Sciegen Pharms Inc, 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-eight NDAs. There are eighteen 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 seventy-two patent family members in thirty-two countries.

There are seventeen drug master file entries for glycopyrrolate. Fifty-nine suppliers are listed for this compound.

Summary for glycopyrrolate

International Patents:	172
US Patents:	18
Tradenames:	10
Applicants:	55
NDAs:	68
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	59
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	173
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
Mount Sinai Hospital, Canada	PHASE2
Wonkwang University Hospital	NA
Prince Sultan Military Medical City	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
Appco	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	207201-001	Jan 3, 2017	AA	RX	No	No
Edenbridge Pharms	DARTISLA ODT	glycopyrrolate	TABLET, ORALLY DISINTEGRATING;ORAL	215019-001	Dec 16, 2021		DISCN	Yes	No
Hikma Farmaceutica	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	090963-001	Sep 21, 2011	AP	RX	No	Yes
Sciegen Pharms Inc	GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	216297-001	Oct 7, 2024	AA	RX	No	No
Lupin Ltd	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	213655-001	Feb 7, 2023		DISCN	No	No
Hikma Intl Pharms	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040836-001	Mar 5, 2009		DISCN	No	No

Expired US Patents for glycopyrrolate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz Pharms	CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571-001	Jul 28, 2010	7,816,396
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	8,580,306
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	7,736,670
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	8,435,567
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	6,521,260
Merz Pharms	CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571-001	Jul 28, 2010	7,638,552

International Patents for glycopyrrolate

Country	Patent Number	Title	Estimated Expiration
Japan	2012213641
Canada	2563573	DISPOSITIF D'INHALATION (INHALER DEVICE)
Norway	20054767
Japan	2007505831
Japan	2006522634
Japan	2012213641	INHALATION THERAPY DEVICE INCLUDING AMPOULE WHICH STORES DRUG TO BE NEBULIZED

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	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435025	19C1040	France		PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

Market Dynamics and Financial Trajectory for Glycopyrrolate

Last updated: July 27, 2025

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Introduction

Glycopyrrolate, a synthetic anticholinergic agent, has experienced evolving significance within the pharmaceutical landscape. Originally developed for adverse muscarinic effects and anesthesia procedures, it has gained expanded therapeutic applications, notably in respiratory and gastrointestinal disorders. This analysis examines the current market dynamics and the financial trajectory of glycopyrrolate, highlighting drivers, challenges, and future growth opportunities to inform stakeholders' strategic decisions.

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Therapeutic Applications and Market Adoption

Glycopyrrolate is primarily used to reduce saliva and airway secretions preoperatively, treat peptic ulcers, and manage hyperhidrosis. Its recent adoption for respiratory conditions, especially as a nebulized therapy for chronic obstructive pulmonary disease (COPD) and bronchorrhea, has expanded its market footprint. The FDA approval of glycopyrrolate inhalers, such as Sunovion's Seebri® (glycopyrrolate inhalation powder), underscores its increasing relevance in respiratory care [1].

Additionally, the rise of glycopyrrolate as a component in combination therapies signals growing demand. The drug's ability to alleviate symptoms associated with excessive secretions and airway constriction makes it attractive amidst the global rise in chronic respiratory diseases, particularly COPD, which ranks among the leading causes of morbidity worldwide [2].

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Market Drivers

1. Growing Prevalence of Respiratory Disorders

The global COPD prevalence is projected to reach approximately 174 million by 2025, driven by risk factors such as smoking, pollution, and aging populations [3]. Glycopyrrolate's efficacy in these conditions positions it favorably against competitors, further stimulated by its inhaled formulations that offer a targeted approach with reduced systemic effects.

2. Advancements in Drug Delivery Technologies

Innovations in drug delivery systems, such as dry powder inhalers (DPIs) and metered-dose inhalers (MDIs), improve patient adherence and therapeutic outcomes. Glycopyrrolate’s formulations leverage these technologies, broadening its clinical applicability and market penetration.

3. Increased Awareness and Diagnostic Rates

Enhanced screening programs for respiratory and gastrointestinal disorders contribute to increased diagnosis rates. As awareness rises, demand for effective, tolerable treatments like glycopyrrolate escalates, positively impacting sales trajectories.

4. Patent Expirations and Generic Competition

While some formulations of glycopyrrolate remain under patent protection, impending expirations could introduce generics, sharply reducing costs and expanding access, especially in emerging markets. This is expected to stimulate volume sales, although it may pressure margins for branded suppliers.

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Market Challenges

1. Competitive Landscape

Glycopyrrolate faces competition from other anticholinergics such as tiotropium, ipratropium, and new long-acting muscarinic antagonists (LAMAs). Its differentiation hinges on delivery methods, side effect profiles, and formulation efficacy. Established market players with broader pipelines can threaten glycopyrrolate’s market share.

2. Regulatory Hurdles

Regulatory agencies have stringent requirements for novel formulations and indications. Delays or rejections can impede market expansion, especially in regions with complex approval processes like the EU and China.

3. Side Effects and Patient Acceptance

Though generally well-tolerated, glycopyrrolate's anticholinergic activity can lead to dry mouth, urinary retention, and blurred vision, possibly limiting usage in certain patient populations. Managing adverse effects is essential for maintaining market growth.

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Financial Trajectory and Revenue Outlook

1. Current Market Size and Growth Estimates

The global respiratory pharmacology market, including glycopyrrolate’s segment, is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five years, driven by the obesity epidemic-related peptic ulcer treatments and rising COPD prevalence [4]. Glycopyrrolate’s contribution within this segment is expected to expand correspondingly, particularly in North America, Europe, and emerging markets.

2. Revenue Sources and Market Share

Major revenue streams stem from inhaled formulations (Seebri®, Lonhala® Magnaior) and injectable forms used preoperatively. In 2022, these products collectively generated an estimated $300-400 million globally, with North America constituting nearly 60% due to higher disease prevalence and healthcare spending [5].

3. Impact of Patent Expiry and Generics

Patent cliffs anticipated within the next 3-5 years could lead to significant generic entry, potentially reducing prices by up to 60-70%. While initial revenue may decline, increased volume sales in price-sensitive markets could offset margins, supporting long-term growth.

4. Strategic Collaborations and Market Expansion

Partnerships with biotech firms for novel formulations, device upgrades, and combination therapies (e.g., glycopyrrolate with indacaterol) could enhance product lifecycle and revenue. Notably, strategic expansion into Asian and Latin American markets, where respiratory disease burdens are rising, presents substantial upside.

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Future Outlook and Growth Opportunities

1. Innovative Delivery Platforms

Investments in smart inhaler technology and sustained-release formulations could improve patient compliance and therapeutic efficacy, fostering market differentiation. Emerging research on nanoparticle encapsulation and liposomal delivery systems may further refine glycopyrrolate’s performance.

2. Expanded Disease Indications

Clinical trials exploring glycopyrrolate’s utility in conditions like hyperhidrosis, neuromuscular diseases, and certain gastrointestinal disorders could unlock new markets, diversifying revenue streams.

3. Personalized Medicine Approaches

Advances in pharmacogenomics could optimize glycopyrrolate’s use, identify responsive patient subgroups, and facilitate targeted therapies, promoting market growth within precision medicine frameworks.

4. Regulatory Approvals in Emerging Markets

Favorable regulatory environments and increasing healthcare infrastructure investment in developing countries can accelerate adoption, especially if product prices remain competitive.

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Key Takeaways

• Glycopyrrolate’s expanding role in respiratory therapies positions it favorably within a growing global market influenced by rising COPD prevalence and improved delivery technologies.
• Patent expirations and subsequent generic competition threaten near-term revenue but may stimulate volume growth, especially in price-sensitive emerging markets.
• Strategic innovation, including development of new formulations and combination therapies, will be pivotal for sustaining market share and enhancing profitability.
• Regulatory navigation and adverse effect management are ongoing challenges requiring focused engagement.
• Broader application prospects through clinical research and personalized medicine could unlock new revenue streams and extension of market presence.

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FAQs

1. What are the primary indications for glycopyrrolate?
Glycopyrrolate is mainly indicated for preoperative reduction of saliva and airway secretions, treatment of peptic ulcers, and management of hyperhidrosis. Recently, it is increasingly used in respiratory conditions like COPD and bronchorrhea.

2. How does glycopyrrolate compare to other anticholinergic agents?
Glycopyrrolate offers targeted peripheral action with reduced central nervous system penetration, resulting in fewer CNS side effects compared to some other anticholinergics. Its inhaled formulations have demonstrated comparable efficacy with improved tolerability in respiratory therapy.

3. What factors could influence the future market growth of glycopyrrolate?
Future growth is influenced by rising respiratory disease prevalence, technological advances in inhaler devices, patent expirations, regulatory approvals in emerging markets, and clinical trial outcomes expanding indications.

4. Are there any significant patent expirations anticipated for glycopyrrolate?
Yes, patent deadlines within the next 3-5 years are expected, potentially facilitating generic entry that could impact pricing and revenue.

5. What are the main challenges faced by glycopyrrolate manufacturers?
Challenges include intense competition, regulatory hurdles, managing side effects, and navigating market access in different regions.

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Sources

1. Sunovion Pharmaceuticals. Seebri® (glycopyrrolate inhalation powder). [Link]
2. World Health Organization. Global Surveillance Report on COPD. (2022)
3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2023 Report.
4. MarketsandMarkets. Respiratory Drug Market Analysis. (2022)
5. IQVIA. Pharmaceutical Market Data. (2022)