Last Updated: June 17, 2026

Cycrimine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Cycrimine hydrochloride is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for cycrimine hydrochloride
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 24
DailyMed Link:cycrimine hydrochloride at DailyMed

US Patents and Regulatory Information for cycrimine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly PAGITANE cycrimine hydrochloride TABLET;ORAL 008951-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly PAGITANE cycrimine hydrochloride TABLET;ORAL 008951-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Cycrimine Hydrochloride

Last updated: February 15, 2026

Cycrimine hydrochloride, known generically as a muscarinic receptor antagonist, is primarily used to treat gastrointestinal motility disorders, including irritable bowel syndrome and certain types of urinary incontinence. Its market profile, competitive landscape, and financial outlook reflect the current healthcare environment, regulatory status, and evolving therapeutic needs.


Market Size and Growth Drivers

The global demand for antispasmodic agents like cycrimine hydrochloride has remained relatively stable, driven by the prevalence of gastrointestinal and urinary disorders. Estimates indicate a market size valued at approximately $300 million in 2022, with a compound annual growth rate (CAGR) of roughly 3% projected into 2030.[1]

Key growth drivers include:

  • Aging population increasing incidence of motility disorders.
  • Rising awareness of gastrointestinal health management.
  • Expansion in outpatient healthcare services.

The drug's market penetration varies geographically: higher in Europe and Asia Pacific due to favorable prescribing habits and regulatory environments, and comparatively lower in North America, where newer drugs with better side effect profiles dominate.


Competitive Landscape

Cycrimine hydrochloride operates in a segment with several alternative treatments:

  • Dicyclomine.
  • Hyoscine butylberrate.
  • Mebeverine.

These alternatives differ in mechanism, side effects, and regulatory approvals. While cycrimine remains prescribed, patent status offers little protection, rendering it vulnerable to generic competition.

Generic drugs account for approximately 85% of the antispasmodic market share, pressuring pricing. No recent patent extensions or formulations are actively under patent protection.[2]


Regulatory and Patent Considerations

Cycrimine hydrochloride is off-patent globally, which limits exclusivity. Manufacturers rely on generic sales, with limited scope for brand differentiation. The drug's approval status in major markets remains unchallenged, but regulatory authorities emphasize safety and efficacy data, which can influence formulary placements.

Recent regulatory shifts focus on improving safety profiles due to anticholinergic side effects, prompting some providers to favor newer agents or combination therapies.


Financial Trajectory and Revenue Projections

For companies with existing formulations, revenue streams are steady but declining due to market saturation and generic price erosion. Market analysts project a long-term decline of approximately 1-2% annually for cycrimine hydrochloride, attributable to:

  • Competitive generics.
  • Evolving clinical guidelines favoring newer agents with better safety profiles.

In emerging markets, especially in Asia and Latin America, growth remains moderate, with sales expansions driven by increased healthcare access.

Manufacturers with existing inventories can expect a gradual decrease in profit margins unless they innovate or diversify their portfolios.


Investment and R&D Outlook

No significant R&D pipelines for novel cycrimine formulations are evident. Most investment focuses on developing new antispasmodic drugs with differentiated profiles, aiming to replace older agents like cycrimine hydrochloride.

Clusters of innovation in related therapeutic areas involve botulinum toxins and neuromodulators, but their relevance to cycrimine's market is marginal at this stage.


Market Entry Barriers

High barriers include:

  • Entry costs associated with regulatory approval.
  • Pricing pressures from established generics.
  • Low market exclusivity prospects.

New entrants are more likely to focus on alternative approaches or combination therapies rather than reformulations of cycrimine hydrochloride.


Key Takeaways

  • Cycrimine hydrochloride faces declining revenue prospects due to patent expirations and market saturation.
  • Market growth remains modest, driven by aging populations and gastrointestinal disorders.
  • Competition from generics dominates, with limited room for differentiation.
  • Regulatory focus on safety profiles has heightened scrutiny for older antispasmodics.
  • No active R&D pipelines suggest limited future innovations directly involving cycrimine.

FAQs

1. What is the primary therapeutic use of cycrimine hydrochloride?
It treats gastrointestinal spasms and urinary incontinence by relaxing smooth muscles in the gut and urinary tract.

2. How competitive is the market for cycrimine hydrochloride?
Extremely competitive due to the dominance of generic versions and multiple alternative drugs with similar efficacy.

3. What is the future outlook for cycrimine hydrochloride sales?
Sales are expected to decline gradually due to generic competition and evolving treatment preferences favoring newer agents.

4. Are there any ongoing R&D efforts to develop new formulations?
No significant ongoing R&D efforts are publicly known; most companies focus on new compounds rather than reformulating cycrimine.

5. What factors impact regulatory approval for this drug?
Safety concerns, particularly related to anticholinergic side effects, influence regulatory evaluations and formulary decisions worldwide.


Sources

[1] MarketResearch.com, "Antispasmodic Drugs Market Analysis," 2022.
[2] U.S. Patent and Trademark Office, Patent Status Database, 2023.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.