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 Pharma Ltd, 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, Annora Pharma, Chartwell Rx, Endo Operations, Granules, Saptalis Pharms, Suven Pharms, Edenbridge Pharms, Adaptis, Aurobindo Pharma, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Rising, Sun Pharm Inds Ltd, Velzen Pharma Pvt, Casper Pharma Llc, and Azurity, and is included in sixty-five NDAs. There are seventeen 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-six patent family members in thirty-two countries.

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

Summary for GLYCOPYRROLATE

International Patents:	176
US Patents:	17
Tradenames:	10
Applicants:	53
NDAs:	65
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	57
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	156
Patent Applications:	6,807
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 California, Irvine	Phase 4
Clayton Petro	Phase 4
Jie Chen	Phase 1/Phase 2

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
Lupin Ltd	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	213655-001	Feb 7, 2023		DISCN	No	No
Watson Labs	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	086900-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Heritage Pharms Inc	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	207201-002	Jan 3, 2017	AA	RX	No	No
Chartwell Rx	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040568-002	Dec 22, 2004		DISCN	No	No
Endo Operations	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040653-002	Aug 31, 2006	AA	RX	No	Yes

Expired US Patents for GLYCOPYRROLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Casper Pharma Llc	ROBINUL	glycopyrrolate	TABLET;ORAL	012827-001	Approved Prior to Jan 1, 1982
Merz Pharms	CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571-001	Jul 28, 2010
Casper Pharma Llc	ROBINUL FORTE	glycopyrrolate	TABLET;ORAL	012827-002	Approved Prior to Jan 1, 1982
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015

International Patents for GLYCOPYRROLATE

Country	Patent Number	Title	Estimated Expiration
Israel	178878	מתקן משאף (Inhaler device)
World Intellectual Property Organization (WIPO)	2004093848
European Patent Office	1663180	COMPOSITIONS PHARMACEUTIQUES PERMETTANT DE TRAITER L'EJACULATION PRECOCE PAR INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS FOR TREATING PREMATURE EJACULATION BY PULMONARY INHALATION)
Germany	60235883
Germany	10250625	Inhalationstherapievorrichtung

Supplementary Protection Certificates for GLYCOPYRROLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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

GLYCOPYRROLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glycopyrrolate

Introduction to Glycopyrrolate

Glycopyrrolate is a nonselective antagonist of muscarinic cholinergic receptors, widely used in various medical applications, including the treatment of peptic ulcers, excessive drooling in cerebral palsy patients, and as an adjunct in anesthesia. Here, we delve into the market dynamics and financial trajectory of glycopyrrolate, exploring its current state, future projections, and key factors influencing its market growth.

Market Size and Growth Projections

The glycopyrrolate market has experienced rapid and substantial growth in recent years. According to market research reports, the market is expected to continue this upward trend from 2023 to 2031, with a remarkable Compound Annual Growth Rate (CAGR) during the forecast period[1][2][4].

Glycopyrrolate Market Segments

The market is segmented based on type, application, and geographical regions.

• Type: The market includes glycopyrrolate tablets and solutions. For glycopyrrolate injections, specific concentrations such as 0.2mg/ml, 0.4mg/2ml, 1mg/5ml, and 4mg/20ml are also categorized[1][2][4].
• Application: The primary applications are in hospitals, clinics, and other healthcare settings.
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa.

Market Dynamics

Drivers

Several factors are driving the growth of the glycopyrrolate market:

• Increasing Demand in Healthcare: The rising need for effective treatments in hospitals and clinics, particularly for conditions like peptic ulcers and cerebral palsy, is a significant driver[1][2][4].
• Advancements in Formulations: The development of new formulations, such as glycopyrrolate oral solutions and injections, has improved the efficacy and safety profile of the drug, attracting more patients and healthcare providers[5].
• Expanding Patient Base: The growing prevalence of conditions that require glycopyrrolate treatment, such as neurodevelopmental deficits and severe asthma, contributes to market growth[3].

Restraints

Despite the positive outlook, there are several restraints to consider:

• Side Effects and Safety Concerns: Glycopyrrolate can cause anticholinergic side effects, which may limit its use in certain patient populations. Long-term animal studies to evaluate carcinogenic and reproductive toxicity are also necessary[5].
• Regulatory Requirements: Post-marketing studies and regulatory approvals can be time-consuming and costly, potentially slowing market growth[5].

Opportunities

The glycopyrrolate market presents several opportunities:

• Emerging Markets: Expanding into emerging economies, where healthcare infrastructure is improving, offers significant growth potential[1][2][4].
• New Indications: Research into new therapeutic uses, such as severe asthma treatments (e.g., PT010 by AstraZeneca), can expand the market[3].

Challenges

The market also faces several challenges:

• Competition: The presence of other anticholinergic drugs and emerging therapies in related therapeutic areas can pose competition[3].
• Economic and Political Factors: Economic downturns and political instability in certain regions can affect market growth[1][2][4].

Financial Trajectory

Revenue Projections

The glycopyrrolate market is projected to achieve substantial revenue growth from 2023 to 2031. The market size is measured in USD million, with forecasts indicating a significant increase in revenue across various segments[1][2][4].

Key Players and Market Share

Several key players are dominant in the glycopyrrolate market, including Toobapharma, Infa Group, Suven Life Sciences Limited, and others. These companies are investing in research and development to enhance product offerings and expand their market share[1][2][4].

Geographical Analysis

The market is geographically diverse, with different regions contributing to its growth:

• North America and Europe: These regions are expected to remain significant due to advanced healthcare infrastructure and high demand for glycopyrrolate products[1][2][4].
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare spending and a large patient base[1][2][4].

Consumer Behavior and Economic Landscapes

Consumer behavior and economic landscapes play crucial roles in shaping the market:

• Consumer Awareness: Increasing awareness about the benefits of glycopyrrolate among patients and healthcare providers is driving demand[1][2][4].
• Economic Factors: The economic stability of countries and their healthcare spending patterns significantly influence market growth[1][2][4].

Regulatory Environment

The regulatory environment is critical for the glycopyrrolate market:

• FDA Approvals: Glycopyrrolate products, such as oral solutions, have received FDA approvals, which have expanded their use and acceptance[5].
• Post-Marketing Studies: Regulatory requirements for post-marketing studies ensure the ongoing safety and efficacy of glycopyrrolate products[5].

Conclusion

The glycopyrrolate market is poised for significant growth driven by increasing demand, advancements in formulations, and expanding patient bases. While it faces challenges such as side effects and regulatory requirements, the market's financial trajectory is optimistic, with substantial revenue projections and opportunities for expansion into emerging markets.

Key Takeaways

• Rapid Market Growth: The glycopyrrolate market is expected to grow substantially from 2023 to 2031.
• Segmented Market: The market is segmented by type, application, and geographical regions.
• Drivers and Restraints: Increasing demand, new formulations, and expanding patient bases drive growth, while side effects and regulatory requirements pose restraints.
• Geographical Diversity: North America, Europe, and Asia-Pacific are key regions contributing to market growth.
• Regulatory Environment: FDA approvals and post-marketing studies are crucial for market expansion.

FAQs

Q1: What are the primary applications of glycopyrrolate?

Glycopyrrolate is primarily used in hospitals and clinics for the treatment of peptic ulcers, excessive drooling in cerebral palsy patients, and as an adjunct in anesthesia.

Q2: Which regions are expected to drive the growth of the glycopyrrolate market?

North America, Europe, and the Asia-Pacific region are anticipated to be significant contributors to the market growth due to their advanced healthcare infrastructure and large patient bases.

Q3: What are the key drivers of the glycopyrrolate market?

The key drivers include increasing demand in healthcare, advancements in formulations, and an expanding patient base due to the growing prevalence of related conditions.

Q4: What are the potential restraints to the glycopyrrolate market?

Potential restraints include anticholinergic side effects, regulatory requirements for post-marketing studies, and competition from other therapeutic options.

Q5: Which companies are major players in the glycopyrrolate market?

Major players include Toobapharma, Infa Group, Suven Life Sciences Limited, and other pharmaceutical companies investing in glycopyrrolate products.

Sources

1. Market Research Intellect: Global Glycopyrrolate Market Size, Trends and Projections[1].
2. Market Research Intellect: Glycopyrrolate Injection Market Size, Scope And Forecast Report[2].
3. Patsnap: Percussionaire Corp. - Drug pipelines, Patents, Clinical trials[3].
4. Market Research Intellect: Global Glycopyrrolate Injection Market Size, Trends and Projections[4].
5. FDA: Glycopyrrolate Oral Solution NDA 22-571[5].