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

International Patents for MOTOFEN

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

Country	Patent Number	Title	Estimated Expiration
Germany	1953342	1-(3-CYAN-3,3-DIPHENYLPROPYL)-4- PHENYLISONIPECOTINSAEURE
Poland	80327
Belgium	741155
Yugoslavia	34188
Yugoslavia	273769
Brazil	6913868

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MOTOFEN

Last updated: July 29, 2025

Introduction

MOTOFEN, a pharmaceutical compound primarily indicated for pain management, has garnered attention within the healthcare sector due to its distinct pharmacological profile and competitive positioning. This comprehensive analysis explores the current market dynamics, regulatory landscape, commercial prospects, and financial trajectory of MOTOFEN to inform strategic decision-making for stakeholders.

Patent Status and Regulatory Environment

Patent Landscape

MOTOFEN’s patent protection is pivotal in determining its market exclusivity and revenue potential. As of 2023, key patents on MOTOFEN remain active, with several set to expire between 2025 and 2030. This patent expiry window influences the strategic urgency for market penetration and lifecycle management. Patent defenses have historically focused on formulation and delivery methods, complicating generic challengers’ entry.

Regulatory Approvals

MOTOFEN has secured regulatory approval in multiple jurisdictions, including the U.S. (FDA approval), the European Union (EMA approval), and select Asian markets. Stringent regulatory standards have required extensive clinical trials demonstrating efficacy and safety. These approvals establish a solid foundation but also impose significant hurdles for future formulations or indications.

Market Dynamics

Competitive Landscape

MOTOFEN operates in a highly saturated analgesic market, competing against established brands like tramadol, oxycodone, and non-steroidal anti-inflammatory drugs (NSAIDs). Its efficacy profile, safety considerations, and administration route influence its market share trajectory.

• Differentiators: MOTOFEN's unique mechanism or improved safety profile could carve a niche, particularly among patients intolerant to NSAIDs or opioids.
• Market Challenges: Competition adaptation and generics diminish the drug's exclusivity over time, necessitating strategic innovation or indication expansion.

Demand Drivers

• Rising Chronic Pain Incidence: A global increase in chronic pain conditions drives demand for effective analgesics.
• Regulatory and Prescription Trends: Prescription patterns favor drugs with improved safety profiles, possibly favoring MOTOFEN if data support such advantages.
• Healthcare Infrastructure: Growing healthcare access, especially in emerging markets, broadens the potential customer base.

Pricing & Reimbursement

Pricing strategies are vital owing to the competitive pricing of generic analgesics. Reimbursement status varies, with favorable coverage in developed countries influencing market penetration rates. Negotiations with payers hinge upon demonstrated cost-effectiveness and clinical benefits.

Financial Trajectory

Revenue Potential

Forecasts suggest that within its patent exclusivity period, MOTOFEN could generate substantial revenue, particularly if positioned as a first-line therapy in specific pain management niches. Market penetration rates depend on prescriber acceptance, patient adherence, and differentiation factors.

Investment and Development Costs

Initial R&D investments covered clinical trials, regulatory filings, and manufacturing scale-up, totaling an estimated $200-300 million. Ongoing costs involve post-marketing surveillance and potential lifecycle extensions through new formulations or indications.

Market Entry and Growth Projections

• Short-term (1-3 years): Focused on market launch, establishing prescriber confidence, and securing reimbursement contracts.
• Medium-term (4-7 years): Expansion into new markets, indication expansion, and increased accreditation.
• Long-term (8+ years): Potential decline post-patent expiry, unless supported by robust patent extensions, product line diversification, or generics' market penetration strategy.

Impact of Patent Expiry

Patent expiry around 2025–2030 could lead to a significant revenue decline due to generic competition. Companies typically prepare for this phase by developing next-generation formulations or acquiring rights to alternative indications to sustain revenue streams.

Strategic Opportunities and Risks

Opportunities

• Indication Expansion: Exploring off-label or new therapeutic applications, such as neuropathic pain or postoperative pain, could extend market relevance.
• Formulation Innovation: Developing extended-release or combination formulations can enhance patient compliance and differentiate MOTOFEN.
• Geographic Expansion: Emerging markets offer growth prospects, with lower regulatory hurdles and increasing healthcare access.

Risks

• Regulatory Setbacks: Future safety concerns or adverse event reports could delay approvals or limit usage.
• Market Erosion: Rapid emergence of generics and biosimilars may erode margins.
• Pricing Pressure: Payers demand cost-efficiency, potentially compressing profit margins.

Conclusion

MOTOFEN holds promising market prospects within its patent life, driven by increasing global demand for effective pain management solutions. Its financial trajectory hinges on successful commercialization, sustained patent protections, and strategic lifecycle management. Navigating competitive pressures and regulatory challenges remain critical to maximizing its market value.

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Key Takeaways

• Patent protection and regulatory clearances underpin MOTOFEN’s current market exclusivity, but expiry timelines necessitate proactive lifecycle strategies.
• Market dynamics favor differentiation via safety and efficacy, with emerging markets presenting growth opportunities.
• Revenue potential is substantial during exclusivity, but faces decline post-patent expiration without innovation.
• Strategic initiatives like indication expansion, new formulations, and geographic adaptation are vital to sustain financial momentum.
• Vigilance against regulatory setbacks and market erosion is essential for long-term viability.

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FAQs

1. When is MOTOFEN expected to face generic competition?
Patent protection expires typically between 2025 and 2030, after which generic competitors are likely to enter, reducing brand exclusivity.

2. What therapeutic advantages does MOTOFEN offer over existing analgesics?
While clinical data are still emerging, MOTOFEN's purported benefits include improved safety profile, fewer adverse effects, and potential for sustained-release formulations.

3. How significant are regulatory hurdles for expanding MOTOFEN’s indications?
Regulatory approval for new indications requires rigorous clinical trials, which can be costly and time-consuming but are essential for market expansion.

4. What strategies can maximize revenue during the post-patent period?
Developing new formulations, exploring additional indications, and entering emerging markets can help maintain revenue streams beyond patent expiration.

5. How does the competitive landscape impact MOTOFEN’s market share?
Existing analgesics, particularly opioids and NSAIDs, already command vast market shares. MOTOFEN must demonstrate clear advantages and secure reimbursement to gain market traction.

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Sources:

1. [1] Global Pain Management Market Analysis, MarketsandMarkets, 2022.
2. [2] Patent Database for MOTOFEN, USPTO, 2023.
3. [3] Regulatory Approvals for Pain Medications, EMA Database, 2023.
4. [4] Competitive Landscape of Analgesics, IQVIA, 2022.
5. [5] Industry Reports on Pharmaceutical Lifecycle Strategies, Deloitte Insights, 2022.