MOTOFEN Drug Patent Profile

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

Motofen is a drug marketed by Sebela Ireland Ltd 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
Patent Applications:	1,078
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
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Sebela Ireland Ltd	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
Sebela Ireland Ltd	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
Ireland	33602	ISONIPECOTIC ACID DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Switzerland	517742	Procédé pour la préparation d'un acide isonipécotique substitué
Norway	133803
United Kingdom	1234359
U.S.S.R.	489324

MOTOFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Motofen

Introduction to Motofen

Motofen, a brand name for the antiperistaltic anti-diarrheal medication, contains 1.0 mg of difenoxin HCl and 0.025 mg of atropine sulfate. It is used as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea[2].

Market Availability and Pricing

Motofen is currently manufactured by Sebela Pharmaceuticals Inc., although it was previously produced by Valeant Pharmaceuticals, which acquired the drug from Amarin Pharmaceuticals in 2004. The medication is only available by prescription in the United States and does not have a generic equivalent. This exclusivity contributes to its higher pricing compared to other anti-diarrheal medications like Imodium and Lomotil[1].

Insurance Coverage and Consumer Impact

Many U.S. insurance companies do not include Motofen in their formulary drugs, resulting in higher copays for consumers. This is largely due to the medication's high cost and the availability of lower-priced alternatives that can effectively manage diarrhea symptoms. The lack of insurance coverage forces many patients to pay out-of-pocket, with costs reaching up to $200 for a monthly supply[1].

Historical Discontinuation and Reintroduction

Motofen was discontinued by Valeant Pharmaceuticals in 2008, reportedly due to issues with the manufacturer of one of the chemicals used in its production. This discontinuation left many patients with severe irritable bowel syndrome (IBS) without an effective treatment option. However, following significant demand and feedback from patients, Motofen was reintroduced to the market in June 2011[1].

Market Demand and Patient Needs

Despite its niche status, Motofen fills a critical need for patients who do not find relief from other anti-diarrheal medications. The medication's unique formulation makes it indispensable for a small but significant group of patients. This demand, coupled with the lack of generic alternatives, maintains a steady, albeit limited, market for Motofen[1].

Financial Implications for Manufacturers

The production and distribution of Motofen involve significant costs, partly due to the specialized nature of the medication and the lack of economies of scale. The high pricing of Motofen is a result of these costs, as well as the need to recoup investment in a drug with a relatively small market. Despite these challenges, the reintroduction of Motofen indicates that there is enough financial incentive for manufacturers to continue producing the drug[1].

Competitive Landscape

In the broader anti-diarrheal market, Motofen competes with more widely used and lower-priced medications like Imodium and Lomotil. However, its unique formulation and the specific patient needs it addresses mean that it does not directly compete with these drugs but rather serves a distinct segment of the market. This niche positioning allows Motofen to maintain its market presence despite higher costs[1].

Regulatory Environment

Motofen is classified as a Schedule IV controlled substance due to its potential for addiction, particularly at high dosages. This regulatory status adds another layer of complexity to its market dynamics, as it must be prescribed and monitored carefully. The strict regulatory environment also influences the financial trajectory by imposing additional costs related to compliance and monitoring[4].

Patient and Pharmacist Awareness

The discontinuation and subsequent reintroduction of Motofen highlighted a significant issue: many pharmacists and healthcare providers were unaware of the medication's existence or its status. This lack of awareness can impact sales and patient access, underscoring the need for better communication and education within the healthcare community[1].

Supply Chain and Distribution

Motofen is primarily found in smaller, traditional pharmacies rather than major chains. This distribution pattern is partly due to the medication's niche status and the limited demand. The supply chain issues that led to its temporary discontinuation also highlight the vulnerabilities in maintaining a steady supply of this medication[1].

Financial Trajectory

Given the high production costs, limited market size, and lack of generic competition, the financial trajectory for Motofen is characterized by high pricing and limited revenue growth. However, the medication's reintroduction and continued demand ensure that it remains a viable product for manufacturers. The financial sustainability of Motofen is heavily dependent on its ability to serve a specific patient population effectively, despite the higher costs associated with its production and distribution[1].

Key Takeaways

• Niche Market: Motofen serves a specific segment of patients with severe diarrhea who do not find relief from other medications.
• High Pricing: The medication is more expensive than alternatives due to its unique formulation and lack of generic competition.
• Regulatory Status: Classified as a Schedule IV controlled substance, which affects its prescription and monitoring.
• Supply Chain Challenges: Historical discontinuation due to supply chain issues and current distribution mainly through smaller pharmacies.
• Financial Sustainability: Dependent on serving a specific patient population effectively despite high production and distribution costs.

FAQs

Q: Why is Motofen more expensive than other anti-diarrheal medications? A: Motofen is more expensive due to its unique formulation, lack of generic competition, and the high costs associated with its production and distribution.

Q: Is Motofen available in countries other than the United States? A: No, Motofen is only approved and sold in the United States.

Q: What led to the temporary discontinuation of Motofen? A: The temporary discontinuation was due to issues with the manufacturer of one of the chemicals used in its production.

Q: How does Motofen compare to other anti-diarrheal medications like Imodium and Lomotil? A: Motofen serves a distinct segment of the market, addressing needs that other medications do not, despite being more expensive.

Q: Is Motofen safe for use during pregnancy? A: Motofen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no well-controlled studies in pregnant women[4].

References

1. Wikipedia: Motofen
2. DailyMed: Motofen® (difenoxin and atropine sulfate tablets) CIV Rx Only
3. RxList: Motofen (Difenoxin and Atropine): Side Effects, Uses ...
4. Mayo Clinic: Difenoxin and atropine (oral route)