MOTOFEN Drug Patent Profile

When do Motofen patents expire, and when can generic versions of Motofen launch?

Motofen is a drug marketed by Legacy Pharma and is included in one NDA.

The generic ingredient in MOTOFEN is atropine sulfate; difenoxin hydrochloride. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the atropine sulfate; difenoxin hydrochloride profile page.

Summary for MOTOFEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	18
Drug Prices:	Drug price information for MOTOFEN
What excipients (inactive ingredients) are in MOTOFEN?	MOTOFEN excipients list
DailyMed Link:	MOTOFEN at DailyMed

See drug prices for MOTOFEN

Pharmacology for MOTOFEN

Drug Class	Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

US Patents and Regulatory Information for MOTOFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Legacy Pharma	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for MOTOFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982	3,646,207

International Patents for MOTOFEN

See the table below for patents covering MOTOFEN around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	133803
Denmark	129124
Austria	293387
Yugoslavia	273769
United Kingdom	1234359
South Africa	6907742

Market Dynamics and Financial Trajectory for Motofen

Last updated: February 20, 2026

What Is Motofen?

Motofen is a prescription medication combining diphenoxylate and atropine. It treats diarrhea by slowing intestinal motility. Approved by the U.S. Food and Drug Administration (FDA) in 1982, it is classified as a Schedule V controlled substance under the Controlled Substances Act due to its opiate derivative component.

Market Size and Growth Drivers

Global Diarrhea Treatment Market

The diarrhea treatment market is projected to reach USD 8 billion by 2025, growing at a compound annual growth rate (CAGR) of approximately 4.7% (Grand View Research, 2021). Motofen's share remains limited by competition from other therapies.

Factors Influencing Demand

• Prevalence of gastrointestinal disorders: Chronic diarrhea affects an estimated 1-2% of the population globally.
• Growing aging population: An aging demographic increases demand for symptomatic treatments.
• Resurgence of antibiotic-resistant infections: Heightens reliance on supportive symptomatic therapies like Motofen.
• Regulatory policies: Restrictions on opioid formulations influence prescribing practices.

Regional Market Presence

• North America: Largest market, driven by advanced healthcare infrastructure and regulatory approvals.
• Europe: Moderate growth with emphasis on gastrointestinal disorder management.
• Asia-Pacific: Rapidly expanding demand due to increasing healthcare access and disease prevalence.

Competitive Landscape

Motofen's market presence is confined due to limited generic competition and regulatory constraints:

Company/Generic Seller	Market Share	Approximate Price (USD per Rx)	Notes
Perrigo (generic)	<5%	15-20	Limited by regulatory issues
Brand (Upsher-Smith)	Minor	50+	Prescription only

Other competitors focus on alternative antidiarrheal agents like loperamide (Imodium), which holds approximately 60% of the anti-diarrheal market.

Regulatory and Legal Factors

• Controlled Substance Status: Schedule V status limits prescribing flexibility.
• Withdrawal of some formulations: Post-2000, some formulations faced discontinuation due to abuse potential.
• Future policy shifts: Enhanced regulation on opioid-based drugs could impede sales.

Financial Trajectory

Sales and Revenue Trends

• Historical sales (2010-2020): Estimated at USD 50-75 million annually in the U.S.
• Growth patterns: Slight decline observed post-2010, influenced by regulatory scrutiny and availability of alternatives.

• Forecast (2023-2028): Modest growth projection of 2-3% CAGR due to:

  • Limited patent protection: Products often face generic competition.
  • Regulatory constraints: Limit prescribing flexibility.
  • Market saturation: High usage in specific niches reduces growth potential.

Profitability and R&D Outlook

• R&D investments for new indications or formulations are minimal due to existing market saturation.
• Margins are flat, with some margin compression due to generic price erosion.

Strategic Challenges

• Opioid crisis and regulatory restrictions: Heightened scrutiny may reduce prescriptions.
• Limited pipeline: No significant new formulations or indications in advanced stages.
• Market cannibalization: Competition from other antidiarrheal agents further limits growth prospects.

Conclusion: Market and Financial Outlook

Motofen faces a static to mildly declining market environment in the U.S. with global expansion constrained by regulatory and competitive factors. Future revenue growth depends on navigating regulatory challenges, diversifying indications, or developing formulations with lower abuse potential.

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Key Takeaways

• The global diarrhea treatment market approaches USD 8 billion with a CAGR of 4.7%.
• Motofen's sales remain modest, with estimates around USD 50-75 million annually in the U.S.
• Regulatory restrictions due to Schedule V status hinder growth prospects.
• Competition chiefly stems from loperamide, which dominates the anti-diarrheal segment.
• Future growth is limited by market saturation, regulatory hurdles, and lack of pipeline advancements.

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FAQs

Q1: How does regulatory status affect Motofen's market?
A1: As a Schedule V controlled substance, Motofen faces prescribing restrictions and regulatory scrutiny, limiting market expansion.

Q2: What are the main competitors to Motofen?
A2: Loperamide (Imodium) holds the largest market share in anti-diarrheal treatments, with other generic diphenoxylate products competing locally.

Q3: Can new formulations augment Motofen’s sales?
A3: Limited R&D efforts suggest minimal innovation; regulatory challenges also hinder formulation developments.

Q4: How has the opioid crisis impacted Motofen?
A4: Increased regulatory oversight on opioid derivatives has decreased prescribing and led to some formulary restrictions.

Q5: What is the future outlook for Motofen’s financial performance?
A5: Revenue likely remains flat or declines slightly, constrained by market saturation and regulatory limitations.

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References

[1] Grand View Research. (2021). Diarrhea Treatment Market Size, Share & Trends Analysis Report.