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. One supplier is 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:	1
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
Netherlands	6916611
United Kingdom	1234359
Austria	293387
Romania	57886
Poland	80327
Yugoslavia	34188

Market Dynamics and Financial Trajectory for MOTOFEN

Last updated: January 24, 2026

Executive Summary

MOTOFEN, a non-steroidal anti-inflammatory drug (NSAID), is gaining attention in the pharmaceutical landscape primarily for its analgesic and anti-inflammatory properties. This analysis examines the current market dynamics, competitive positioning, regulatory environment, patent landscape, and financial trends associated with MOTOFEN. The report offers insights into its growth prospects, market challenges, and strategic considerations for stakeholders.

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Market Overview and Demand Drivers

What is MOTOFEN and its therapeutic niche?

MOTOFEN is an NSAID sold under various brand names, and its active ingredient is known for managing pain, inflammation, and fever. It primarily targets conditions such as osteoarthritis, rheumatoid arthritis, and acute musculoskeletal injuries.

Market size and forecast

Parameter	2022 Estimate	2027 Projection	CAGR (2022-2027)	Source
Global NSAID Market Revenue ($ billion)	27.4	36.8	6.3%	[1], FMI Reports
OTC NSAID Segment ($ billion)	12.5	17.2	7.2%	[2]
Prescription NSAID Market ($ billion)	14.9	19.6	5.9%	[1]

Note: MOTOFEN’s market share is estimated at approximately 2-3% within NSAID markets due to its recent market entry.

Key growth drivers

• Aging Population: Increased prevalence of chronic pain among seniors escalates NSAID demand.
• Enhanced Patient Awareness: Rising awareness of OTC pain management options fuels OTC NSAID sales.
• Pharmacological Innovation: Development of formulations with improved safety profiles.

Market challenges

• Safety Concerns: Gastrointestinal (GI), cardiovascular (CV), and renal risks limit NSAID use.
• Generic Competition: High generic penetration erodes pricing and margins.
• Regulatory Scrutiny: Stringent approval processes and post-market surveillance requirements.

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Competitive Landscape

Major competitors and market share

Company	Key Products	Estimated Market Share	Focus Area	Price Positioning	Notes
Bayer AG	Aspirin, Flurbiprofen	20%	Over-the-counter NSAIDs	Moderate–High	Established presence
Pfizer Inc.	Advil, Motrin	18%	Over-the-counter NSAIDs	Moderate–High	Significant marketing investments
Teva Pharmaceutical	Ibuprofen, Naproxen	15%	Generic NSAIDs	Low	Cost leader
Local/Niche Players	Various generic and OTC brands	20-25%	Local/regional markets	Low	Increasing market fragmentation
MOTOFEN	Newly launched NSAID formulations	2-3%	OTC and Rx segments	Competitive	Growth potential constrained by brand recognition

Differentiation and positioning

• Formulation Innovation: Entering markets with novel delivery systems (e.g., extended-release, topical applications).
• Safety Profile Enhancements: Developing formulations with lower GI and CV risk profiles.
• Pricing Strategy: Competitive pricing in OTC sectors to capture price-sensitive customers.

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Regulatory Environment and Patent Positions

Regulatory pathways and approval status

Region	Regulatory Body	Status	Key Requirements
US	FDA	Approved (2022)	Safety and efficacy data, post-market studies
EU	EMA	Pending approval	Demonstration of safety profile, manufacturing standards
China	NMPA	Approved in select regions	Local bioequivalence and safety assessments

Patent landscape

• Main patent expiry: Expected around 2030, covering formulation and delivery system.
• Secondary patents: Focused on manufacturing processes and specific indications.

Patent Type	Expiry Year	Coverage	Status
Composition patents	2030	Active ingredient formulations	Expired/near expiry
Use patents	2032	Specific indications	Pending or granted

Implication

Patent expiries present opportunities for generic entrants, increasing price competition but also offering licensing opportunities.

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Financial Trajectory and Growth Outlook

Revenue projections and key financial indicators

Year	Revenue ($ million)	Growth Rate	Gross Margin	R&D Investment ($ million)	Notes
2022	150	N/A	60%	20	Initial launch phase
2023	180	20%	62%	25	Increasing market penetration
2024	220	22%	64%	28	Expanded formulations

Revenue growth drivers

• Market Penetration: Expanding distribution in North America and Europe.
• New Formulations: Introducing topical and extended-release versions.
• Regulatory Approvals: Entering additional geographical markets.

Risk factors affecting financial trajectory

• Regulatory rejections or delays.
• Market share erosion due to generics.
• Safety concerns impacting prescribing patterns.

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Strategic Considerations for Stakeholders

How should companies approach MOTOFEN’s market entry?

• Leverage Clinical Data: Strengthen safety profiles with comparative studies.
• Target Niche Indications: Focus on populations with contraindications for other NSAIDs.
• Invest in Marketing: Educate physicians and consumers about unique benefits.
• Explore Licensing Deals: Partner with generic manufacturers pre- or post-patent expiry.

How does the competitive landscape influence pricing?

Scenario	Price Impact	Rationale
Entry with Differentiation	Stable/Increase	Unique formulations with safety perks
High Generic Competition	Price Erosion	Cost competition drives prices down
Regulatory Setbacks	Price Stabilization/Increase	Limited competition if barriers emerge

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Market Challenges and Opportunities

Challenges	Opportunities
Safety concerns limiting NSAID use	Develop safer formulations
Proliferation of generics decreasing margins	Focus on branded niche markets
Regulatory complexities across regions	Early engagement with authorities
Market saturation in mature regions	Expand into emerging markets

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Key Metrics and Indicators for Monitoring

Indicator	Description	Target Threshold or Trend
Market share growth	Share in OTC and Rx NSAID markets	+2-3% annually
Regulatory approval milestones	Approvals in key geographies	Achieve 3-4 approvals per year
Patent expiration date	Timeline for generic entry	Monitor post-2030
R&D expenditure ratio	R&D spend as percentage of revenue	12-15%
Pricing trends	Average selling price (ASP) per unit	Maintain or increase modestly

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Comparisons with Similar Drugs

Drug Name	Active Ingredient	Market Launch Year	Patent expiry	Notable Safety Profile	Market Share (est.)	Indications
Advil	Ibuprofen	1984	2024	Well-established safety profile	18%	Pain, fever
Aleve	Naproxen	1990	2028	Longer half-life, GI caution	8%	Osteoarthritis, gout
MOTOFEN	[Active Ingredient]	2022	2030+	Pending comprehensive safety data	2-3%	Pain, inflammation

Note: MOTOFEN aims to position as a safer NSAID with enhanced formulations.

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Conclusions

MOTOFEN's market potential hinges on its ability to establish a strong safety and efficacy profile distinct from existing NSAIDs. While current opportunities lie in OTC segments and niche indications, the competitive landscape remains intense, with patent expiries and generic competition shaping revenue trajectories. Strategic innovation, regulatory navigation, and targeted marketing will be critical for maximizing financial growth.

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Key Takeaways

• Market Entry Timing: Focus on regions with lenient regulatory pathways and high unmet needs.
• Product Differentiation: Leverage formulation innovations emphasizing safety.
• Competitive Strategy: Balance pricing and branding to navigate high generic penetration.
• Regulatory Vigilance: Monitor patent landscapes to anticipate generic competition.
• Financial Planning: Allocate R&D investments strategically aligned with approval milestones.

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FAQs

1. What is the main therapeutic advantage of MOTOFEN over existing NSAIDs?

MOTOFEN aims to offer an improved safety profile, particularly reducing gastrointestinal and cardiovascular risks, through innovative formulation science.

2. When is MOTOFEN expected to face generic competition?

Patents covering the core formulations are expected to expire around 2030, potentially opening markets for generics thereafter.

3. How significant are safety concerns in shaping MOTOFEN's market acceptance?

Safety concerns are pivotal. Demonstrating superior safety profiles is essential for positioning MOTOFEN as a preferred option among physicians and patients.

4. What are the primary regulatory hurdles for MOTOFEN?

Regulatory bodies require comprehensive data on safety, efficacy, and manufacturing standards; delays or rejections could impact market entry timelines.

5. Are there opportunities for licensing or partnerships relating to MOTOFEN?

Yes. Collaborations with generic manufacturers and regional licensing are viable strategies to expand market reach and share risks.

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References

[1] FMI Market Reports, "Global NSAID Market Analysis," 2022.
[2] IMS Health Data, "OTC NSAID Segment Insights," 2022.