MOTOFEN HALF-STRENGTH Drug Patent Profile

Which patents cover Motofen Half-strength, and what generic alternatives are available?

Motofen Half-strength is a drug marketed by Sebela Ireland Ltd and is included in one NDA.

The generic ingredient in MOTOFEN HALF-STRENGTH 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 HALF-STRENGTH

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
DailyMed Link:	MOTOFEN HALF-STRENGTH at DailyMed

Pharmacology for MOTOFEN HALF-STRENGTH

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

US Patents and Regulatory Information for MOTOFEN HALF-STRENGTH

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 HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for MOTOFEN HALF-STRENGTH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982	3,646,207

International Patents for MOTOFEN HALF-STRENGTH

See the table below for patents covering MOTOFEN HALF-STRENGTH 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
Luxembourg	59733
Czechoslovakia	156461

MOTOFEN HALF-STRENGTH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Motofen

Introduction to Motofen

Motofen, a brand name for the combination medication containing 1.0 mg difenoxin HCl and 0.025 mg atropine, is used to treat severe diarrhea in adults. This medication is unique due to its specific formulation and the challenges it has faced in the market.

Market Availability and Pricing

Motofen is available only by prescription in the United States and is manufactured exclusively by Valeant Pharmaceuticals, which acquired the drug from Amarin Pharmaceuticals in 2004[1][3].

Pricing and Affordability

Motofen is notable for its high cost compared to other anti-diarrheal medications like Imodium and Lomotil. It does not have a generic equivalent, which contributes to its higher price. Many insurance companies do not include Motofen in their formulary, resulting in high copays or out-of-pocket expenses for consumers. This can be as high as $200 for a monthly supply, making it a significant financial burden for those who rely on it[1].

Market Demand and User Base

Despite its high cost, Motofen has a dedicated user base, particularly among individuals with severe irritable bowel syndrome (IBS) who find that other medications like Imodium or Lomotil are not effective. The discontinuation of Motofen by Valeant Pharmaceuticals in 2008 left many patients scrambling to find remaining stocks, often traveling long distances to smaller, independent pharmacies to obtain the medication[1].

Supply Chain and Manufacturing Issues

The initial discontinuation of Motofen was attributed to issues with the manufacturer of one of the chemicals used in difenoxin, although the specifics were not publicly disclosed. This disruption highlighted the vulnerability of the supply chain for niche medications. However, due to strong demand and advocacy from patients, Motofen was reintroduced to the market in June 2011[1].

Regulatory Status

Motofen is classified as a Schedule IV controlled substance due to the potential for addiction and dependence associated with its active ingredient, difenoxin hydrochloride. This regulatory status adds another layer of complexity to its market dynamics, as it must be prescribed and monitored carefully[3].

Clinical and Therapeutic Value

Motofen is indicated for the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea. Its unique combination of difenoxin and atropine makes it more effective than some other anti-diarrheal medications, such as Lomotil, in treating these conditions. However, its use must be balanced against potential side effects and the need for careful fluid and electrolyte management[2][5].

Financial Impact on Patients and Healthcare Systems

The high cost of Motofen can have significant financial implications for patients, particularly those without adequate insurance coverage. For healthcare systems, the inclusion of Motofen in formularies can be a challenge due to its expense and the availability of cheaper alternatives. However, for patients who derive substantial benefit from Motofen, the medication's value outweighs the cost, making it a necessary expenditure despite the financial strain[1].

Market Competition

Motofen operates in a competitive market for anti-diarrheal medications, but its unique formulation and efficacy set it apart. However, the absence of a generic equivalent and the high pricing strategy limit its market share. Other medications like Imodium and Lomotil, which are more affordable and widely available, pose significant competition[1].

Future Outlook

Given the dedicated user base and the specific therapeutic needs that Motofen addresses, it is likely that the medication will continue to have a niche market presence. However, the financial trajectory will depend on factors such as changes in insurance coverage, competition from new medications, and any future disruptions in the supply chain.

Potential for Generic Equivalents

The lack of a generic equivalent for Motofen contributes to its high cost. If a generic version were to be developed and approved, it could significantly alter the market dynamics and financial trajectory of the drug, making it more accessible and affordable for patients[1].

Regulatory and Policy Changes

Any changes in regulatory policies or healthcare reimbursement strategies could impact the financial viability of Motofen. For instance, if more insurance plans were to cover Motofen or if there were incentives for the development of generic equivalents, this could improve the medication's market position and reduce the financial burden on patients[1].

Key Takeaways

• High Cost and Limited Availability: Motofen is expensive and only available by prescription in the U.S., with no generic equivalent.
• Dedicated User Base: Despite high costs, Motofen has a loyal user base among those with severe IBS.
• Supply Chain Vulnerabilities: The medication has faced supply chain issues, including a temporary discontinuation.
• Regulatory Status: Classified as a Schedule IV controlled substance due to potential for addiction.
• Therapeutic Value: More effective than some other anti-diarrheal medications but requires careful management.

FAQs

What is Motofen used for?

Motofen is used as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea[2][5].

Why is Motofen so expensive?

Motofen is expensive because it does not have a generic equivalent, and it is only manufactured by one company, Valeant Pharmaceuticals. Additionally, many insurance companies do not include it in their formularies, leading to high out-of-pocket costs for consumers[1].

Is Motofen available in other countries?

No, Motofen is only prescribed, approved, and sold in the United States[1].

What are the potential side effects of Motofen?

Motofen can cause physical and mental withdrawal symptoms, and its use must be balanced against potential side effects such as severe dehydration, electrolyte imbalance, and respiratory depression in cases of overdose[1][3][5].

Why was Motofen temporarily discontinued?

Motofen was temporarily discontinued due to issues with the manufacturer of one of the chemicals used in its production, although the specifics were not publicly disclosed[1].

References

1. Wikipedia: Motofen
2. Mayo Clinic: Difenoxin and atropine (oral route)
3. RxList: Motofen (Difenoxin and Atropine)
4. Drugs.com: Motofen: Package Insert / Prescribing Information