TROSPIUM CHLORIDE - Generic Drug Details

What are the generic drug sources for trospium chloride and what is the scope of freedom to operate?

Trospium chloride is the generic ingredient in four branded drugs marketed by Allergan, Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, Macleods Pharms Ltd, and Bristol-myers, and is included in fifteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for trospium chloride. Nineteen suppliers are listed for this compound.

Summary for TROSPIUM CHLORIDE

US Patents:	10
Tradenames:	4
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	21
Patent Applications:	1,374
Drug Prices:	Drug price trends for TROSPIUM CHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TROSPIUM CHLORIDE
What excipients (inactive ingredients) are in TROSPIUM CHLORIDE?	TROSPIUM CHLORIDE excipients list
DailyMed Link:	TROSPIUM CHLORIDE at DailyMed

See drug prices for TROSPIUM CHLORIDE

Recent Clinical Trials for TROSPIUM CHLORIDE

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

Sponsor	Phase
The University of Texas Medical Branch, Galveston	Early Phase 1
Amiri Hospital	N/A
Mansoura University	N/A

See all TROSPIUM CHLORIDE clinical trials

Pharmacology for TROSPIUM CHLORIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for TROSPIUM CHLORIDE

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for TROSPIUM CHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCTURA XR	Extended-release Capsules	trospium chloride	60 mg	022103	1	2009-03-02

US Patents and Regulatory Information for TROSPIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No			Y
Padagis Us	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091573-001	Nov 17, 2010	AB	RX	No	No
Padagis Us	TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	201291-001	May 24, 2013	AB	RX	No	No
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No
Macleods Pharms Ltd	TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	206472-001	Jun 18, 2024	AB	RX	No	No
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes			Y
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-002	Sep 26, 2024		RX	Yes	No			Y

Expired US Patents for TROSPIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007

TROSPIUM CHLORIDE Market Analysis and Financial Projection Experimental

Trospium Chloride Market Dynamics and Financial Trajectory

Overview of Trospium Chloride

Trospium chloride is an anticholinergic agent primarily used to treat the symptoms of an overactive bladder, including frequent urination and incontinence. It works by relaxing the muscles in the bladder, reducing the daily episodes of incontinence[2].

Market Growth and Forecast

The Trospium Chloride market is anticipated to experience significant growth over the next few years. Here are some key forecasts:

• The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 11.3% from 2024 to 2031, indicating intense competition and robust growth potential[1].
• Another forecast suggests a CAGR of 4.1% from 2024 to 2030, with the market valued at US$ 38 million in 2023 and projected to reach US$ 50 million by 2030[4].

Key Drivers

Several factors are driving the growth of the Trospium Chloride market:

Increasing Prevalence of Overactive Bladder

The rising prevalence of overactive bladder, particularly among the aging population, is a significant driver. As the global population ages, the demand for effective therapeutic solutions for urinary incontinence increases[1].

Advancements in Drug Formulations

Innovations in drug delivery systems, such as extended-release capsules, enhance patient compliance and efficacy. These advancements are crucial in maintaining market growth[1].

Telemedicine Integration

The increasing adoption of telehealth services allows for better patient management and prescription refills, enhancing accessibility to Trospium Chloride[1].

Personalized Medicine

Advances in genetic profiling enable targeted therapies, potentially boosting the effectiveness of Trospium Chloride. Personalized medicine approaches are becoming more prevalent, contributing to market growth[1].

Digital Health Solutions

Digital health apps that facilitate monitoring and adherence to medication regimens are also driving the market. These apps help patients manage their conditions more effectively, promoting the use of Trospium Chloride[1].

Market Segmentation

The Trospium Chloride market is segmented based on several factors:

By Application

The market is segmented into hospital and drug store applications. Hospitals and drug stores are the primary distribution channels for Trospium Chloride, with hospitals often being the first point of contact for patients seeking treatment for overactive bladder[3].

By Product

Trospium Chloride is available in various forms, including immediate-release tablets and extended-release capsules. These different formulations cater to different patient needs and preferences[3].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America, particularly the United States, is expected to dominate the market, followed by Europe and the Asia-Pacific region[1].

Key Companies and Market Share

Several pharmaceutical companies are prominent in the Trospium Chloride market:

• Teva: Known for its strong distribution network and established brand recognition, Teva is a leading player in the market[1].
• Apotex: Apotex holds a significant market share due to its competitive pricing and generic offerings[1].
• Perrigo: Perrigo also has a substantial market share, driven by its competitive pricing and wide distribution network[1].
• Glenmark Pharmaceuticals: Glenmark is recognized for its innovative approaches and expanding product portfolio[1].
• Heritage Pharmaceuticals: Heritage contributes with cost-effective solutions, making the medication more accessible to a broader patient base[1].

Financial Trajectory

The financial outlook for the Trospium Chloride market is positive:

• The market was valued at US$ 38 million in 2023 and is expected to reach US$ 50 million by 2030, growing at a CAGR of 4.1% during the forecast period[4].
• Another report indicates that the market is anticipated to grow at an annual rate of 11.3% from 2024 to 2031, reflecting a more aggressive growth trajectory[1].

Regional Market Performance

The market performance varies by region:

• North America: Expected to dominate the market with approximately 40% market share, driven by the high prevalence of overactive bladder in the United States[1].
• Europe: Germany and the UK are significant contributors, holding around 30% of the market share[1].
• Asia-Pacific: Led by China and India, this region is expected to capture about 20% of the market share[1].
• Latin America and Middle East & Africa: These regions collectively contribute around 10% of the market share, with growth expected as awareness of urological disorders increases[1].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces several challenges:

• Stringent Regulatory Approvals: Companies must navigate strict regulatory environments, which can slow market entry and expansion[1].
• High Competition: The market is highly competitive, with multiple players vying for market share. This competition can drive innovation but also presents challenges for new entrants[1].

To overcome these challenges, companies can focus on:

• Partnerships for Research and Development: Collaborating with other companies and research institutions to develop new formulations and combination therapies[1].
• Targeted Marketing Strategies: Educating patients and healthcare providers about the benefits of Trospium Chloride through direct-to-consumer marketing and partnerships with healthcare providers[1].
• Leveraging Data Analytics: Using data analytics to personalize treatments and improve patient outcomes, which can enhance market positioning[1].

Key Takeaways

• The Trospium Chloride market is expected to grow significantly, driven by increasing prevalence of overactive bladder and advancements in drug formulations.
• Key drivers include telemedicine integration, personalized medicine, and digital health solutions.
• The market is dominated by companies like Teva, Apotex, Perrigo, Glenmark Pharmaceuticals, and Heritage Pharmaceuticals.
• Regional performance varies, with North America leading the market.
• Challenges include stringent regulatory approvals and high competition, which can be addressed through strategic partnerships and targeted marketing.

FAQs

What is Trospium Chloride used for?

Trospium Chloride is used to treat the symptoms of an overactive bladder, such as frequent urination and incontinence[2].

What are the key drivers of the Trospium Chloride market?

Key drivers include the increasing prevalence of overactive bladder, advancements in drug formulations, telemedicine integration, personalized medicine, and digital health solutions[1].

Which companies are prominent in the Trospium Chloride market?

Prominent companies include Teva, Apotex, Perrigo, Glenmark Pharmaceuticals, and Heritage Pharmaceuticals[1].

What is the expected CAGR of the Trospium Chloride market from 2024 to 2031?

The market is expected to grow at a CAGR of 11.3% from 2024 to 2031[1].

What are the primary distribution channels for Trospium Chloride?

The primary distribution channels are hospitals and drug stores[3].

What are the common side effects of Trospium Chloride?

Common side effects include dry mouth, constipation, indigestion, and difficulty passing urine. More severe side effects can include angioedema and blurred vision[2].

Sources

1. Jullynassa, Hashnode: The Trospium Chloride Market, anticipated to grow at a predicted CAGR of 11.3%...
2. Mayo Clinic: Trospium (oral route) - Mayo Clinic
3. MarketResearchIntellect: Global trospium chloride market size and forecast 2
4. Valuates Reports: Trospium Chloride Market, Report Size, Worth, Revenue, Growth...