PROPANTHELINE BROMIDE Drug Patent Profile

Which patents cover Propantheline Bromide, and what generic alternatives are available?

Propantheline Bromide is a drug marketed by Ascot, Heather, Hikma, Impax Labs, Mylan, Par Pharm, Pvt Form, Sandoz, Tablicaps, and Watson Labs. and is included in eleven NDAs.

The generic ingredient in PROPANTHELINE BROMIDE is propantheline bromide. There are seven drug master file entries for this compound. Additional details are available on the propantheline bromide profile page.

Summary for PROPANTHELINE BROMIDE

US Patents:	0
Applicants:	10
NDAs:	11
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	2
DailyMed Link:	PROPANTHELINE BROMIDE at DailyMed

Recent Clinical Trials for PROPANTHELINE BROMIDE

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

Sponsor	Phase
Hospital Universitário Professor Edgard Santos	Phase 1
Chongqing Medical University	Phase 4

See all PROPANTHELINE BROMIDE clinical trials

Medical Subject Heading (MeSH) Categories for PROPANTHELINE BROMIDE

Anti-Ulcer Agents

Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PROPANTHELINE BROMIDE

A03AB	Synthetic anticholinergics, quaternary ammonium compounds
A03A	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for PROPANTHELINE BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascot	PROPANTHELINE BROMIDE	propantheline bromide	TABLET;ORAL	087663-001	Oct 25, 1982		DISCN	No	No
Par Pharm	PROPANTHELINE BROMIDE	propantheline bromide	TABLET;ORAL	088377-001	Dec 8, 1983		DISCN	No	No
Hikma	PROPANTHELINE BROMIDE	propantheline bromide	TABLET;ORAL	080927-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	PROPANTHELINE BROMIDE	propantheline bromide	TABLET;ORAL	083151-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pvt Form	PROPANTHELINE BROMIDE	propantheline bromide	TABLET;ORAL	080977-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Heather	PROPANTHELINE BROMIDE	propantheline bromide	TABLET;ORAL	085780-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Summary

Last updated: February 12, 2026

Propantheline bromide’s market is limited, primarily used for gastrointestinal conditions like peptic ulcers, irritable bowel syndrome, and urinary incontinence. The drug’s market dynamics are influenced by the decline of older therapies, regulatory challenges, and the emergence of novel treatments. Financial projection indicates stagnation with slow growth prospects due to patent expirations and competition from newer drugs.

Market Size and Key Drivers

Propantheline bromide is a generic drug with minimal proprietary protections. It is primarily supplied by generic manufacturers. The global market for gastrointestinal antispasmodics, which includes propantheline bromide, is expected to reach approximately USD 1.2 billion by 2025, expanding at a compound annual growth rate (CAGR) of 2.8% from 2020. The small market share of propantheline bromide is because of its age, safety profile concerns, and competition from drugs with better tolerability.

Major factors influencing this market include:

• Patent expiration: The drug is off patent in most regions, leading to increased generic competition and price erosion.

• Clinical preference shifts: Clinicians favor drugs with fewer side-effects, such as hyoscine butylberrate and mebeverine.

• Regulatory environment: Regulatory agencies have increased oversight on older drugs due to safety concerns, impacting their market penetration.

• Alternative therapies: The advent of newer, targeted therapies for gastrointestinal disorders reduces demand for propantheline bromide.

Market Geography

• North America: Remains the largest market with stable demand due to established prescribing habits, but growth is limited.

• Europe: Similar to North America, with high generic penetration, leading to price competition.

• Asia-Pacific: Growth potential exists due to increasing healthcare access, but market penetration is constrained by physicians' preference for newer therapies.

Financial Trajectory and Outlook

• Revenue Trends: Current revenue estimates for propantheline bromide are around USD 25-50 million annually, primarily from generic sales in mature markets. Revenue decline is forecasted at approximately 1-2% annually over the next five years, driven by market saturation and generic price pressures.

• Pricing Dynamics: Average price per unit has decreased by roughly 15% over the last three years due to generic competition, with further declines expected.

• Research and Development: Investment in new formulations or combination therapies involving propantheline bromide is minimal, given limited interest and market growth prospects.

• Regulatory Considerations: Some regulatory agencies have issued warnings regarding the safety profile of anticholinergic drugs, including propantheline bromide, which could influence future market access.

Competitive Landscape

• Main competitors include other antispasmodics such as hyoscine butylberrate, mebeverine, and dicyclomine.

• Market dominance remains fragmented, with several small-scale producers and some multinational generics players.

• Lack of innovative pipeline developments for propantheline bromide limits strategic growth options.

Implications for Stakeholders

• Pharmaceutical companies: Limited opportunities for investment or development; focus should be on optimizing existing generic portfolios.

• Investors: Expect slow revenue decline with limited prospects for significant growth or innovation.

• Healthcare providers: Preference shifts favor drugs with better side-effect profiles; continued use of propantheline bromide is driven by cost considerations rather than efficacy.

Key Takeaways

• Propantheline bromide is a mature, off-patent drug with declining market share and modest revenues.

• The drug faces competition from newer agents with improved safety and tolerability.

• Market growth is negligible, with revenues expected to decrease marginally due to generic competition and regulatory concerns.

• Innovation or strategic positioning in this space is limited; focus on cost management and portfolio optimization.

• Market dynamics favor generic manufacturers with scale and low-cost production.

FAQs

1. What are the main medical indications for propantheline bromide?
   It treats peptic ulcers, irritable bowel syndrome, and urinary incontinence.

2. Is there potential for propantheline bromide in emerging markets?
   Yes, due to increasing healthcare access, but prescriber preferences for newer drugs limit growth.

3. What factors could extend the drug’s market life?
   Development of new formulations or combination therapies, and regulatory approval for new indications.

4. Are there safety concerns affecting its marketability?
   Yes. As an anticholinergic, propantheline bromide has side effects such as dry mouth, blurred vision, and urinary retention, which contribute to declining use.

5. How is the competitive landscape structured?
   The market is fragmented with several small-scale generics producers competing on price; no major innovator maintains proprietary rights.