NAFTIN Drug Patent Profile

Which patents cover Naftin, and what generic alternatives are available?

Naftin is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in NAFTIN is naftifine hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naftin

A generic version of NAFTIN was approved as naftifine hydrochloride by TARO on January 6^th, 2016.

Summary for NAFTIN

International Patents:	3
US Patents:	6
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	8
Patent Applications:	695
Drug Prices:	Drug price information for NAFTIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAFTIN
What excipients (inactive ingredients) are in NAFTIN?	NAFTIN excipients list
DailyMed Link:	NAFTIN at DailyMed

See drug prices for NAFTIN

Recent Clinical Trials for NAFTIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Therapeutics, Inc.	Phase 1
Genzum Life Sciences	Phase 3
GenZum Life Sciences LLC	Phase 3

See all NAFTIN clinical trials

Pharmacology for NAFTIN

Drug Class

Allylamine Antifungal

Paragraph IV (Patent) Challenges for NAFTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAFTIN	Gel	naftifine hydrochloride	2%	204286	1	2015-02-04

US Patents and Regulatory Information for NAFTIN

NAFTIN is protected by six US patents.

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	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988		DISCN	Yes	No
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	10,695,303		Y
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	9,161,914
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	10,166,206		Y
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-002	Jan 13, 2012	AB	RX	Yes	Yes

Expired US Patents for NAFTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988	4,282,251
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	4,828,251
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	4,282,251

International Patents for NAFTIN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	147068
Austria	A8079
Finland	771242
Germany	2716943
Portugal	66475	PROCEDE POUR LA PREPARATION DE NOUVEAUX COMPOSES ORGANIQUES A EFFET PHARMACEUTIQUE

NAFTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: NAFTIN

Introduction

NAFTIN, a topical antifungal medication containing naftifine hydrochloride, is widely used for the treatment of various fungal infections such as tinea pedis, tinea cruris, and tinea corporis. Understanding the market dynamics and financial trajectory of NAFTIN is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Demand and Supply

The pricing of NAFTIN, like many pharmaceuticals, is influenced by fluctuations in market demand and supply. When demand is high and supply is limited, prices tend to increase. This dynamic is a key factor in the overall market strategy for NAFTIN[3].

Distribution Channels

NAFTIN is distributed through various retail pharmacy settings, including chain drug stores, independent drug stores, mass merchandisers, food stores, and mail-order/specialty pharmacies. However, the majority of packages (approximately 87%) are distributed to U.S. outpatient retail pharmacies, with a smaller percentage going to non-retail and mail-order/specialty pharmacies[1].

Patient Utilization

From October 2014 through July 2017, approximately 306,000 patients received prescriptions for NAFTIN cream and gel in the U.S. outpatient retail pharmacy setting. The pediatric population (0-17 years) accounted for about 5% of these patients, with the majority being between 12-17 years old[1].

Safety and Efficacy

The safety and efficacy of NAFTIN have been extensively studied. Clinical trials, including those involving pediatric patients, have shown that NAFTIN is safe and effective with no significant increase in adverse events compared to the vehicle-treated population. This positive safety profile supports its continued use and market presence[1][4].

Pricing and Cost Considerations

The cost of NAFTIN can be a significant factor for patients. To mitigate this, co-pay savings programs are available, which can reduce out-of-pocket costs for eligible patients. For example, the NAFTIN GEL 2% co-pay savings program can help patients save on their prescriptions, making the medication more accessible[5].

Financial Impact on Pharmaceutical Companies

For pharmaceutical companies like Merz Pharmaceuticals, the manufacturer of NAFTIN, the financial trajectory is influenced by several factors, including sales volume, pricing strategies, and competition. The extension of NAFTIN's indication to pediatric patients has likely expanded its market, contributing to increased revenue.

Market Competition

The antifungal market is competitive, with various products available for treating similar conditions. NAFTIN's market position is maintained through its proven efficacy, safety profile, and the availability of different formulations (cream and gel). The company's efforts to ensure affordability through co-pay assistance programs also help in retaining market share.

Regulatory Environment

Regulatory approvals and postmarketing surveillance play a crucial role in the financial trajectory of NAFTIN. The FDA's extension of the indication for NAFTIN cream to include pediatric patients aged 2 years and older has expanded its market potential. Continuous monitoring of adverse events ensures that the drug remains safe for use, which is vital for maintaining regulatory approval and market confidence[1][4].

Pharmaceutical Company Strategies

Pharmaceutical companies often employ various strategies to maintain and grow their market share. For NAFTIN, this includes ongoing clinical trials, marketing campaigns, and patient assistance programs. These strategies help in maintaining a strong market presence and ensuring the drug's continued financial viability.

Conclusion

The market dynamics and financial trajectory of NAFTIN are influenced by a combination of factors including demand and supply, distribution channels, patient utilization, safety and efficacy, pricing, and regulatory environment. The drug's strong safety profile, expanded indications, and patient assistance programs contribute to its stable market position and financial performance.

Key Takeaways

• Market Demand and Supply: Fluctuations in demand and supply impact pricing.
• Distribution Channels: Majority distributed through U.S. outpatient retail pharmacies.
• Patient Utilization: Pediatric population accounts for about 5% of patients.
• Safety and Efficacy: Proven safety and efficacy in clinical trials.
• Pricing and Cost Considerations: Co-pay savings programs available to reduce costs.
• Financial Impact: Expanded indications and sales volume contribute to revenue.
• Market Competition: Maintained through efficacy, safety, and affordability programs.
• Regulatory Environment: Continuous monitoring and FDA approvals are crucial.

FAQs

Q: What are the common indications for NAFTIN?

A: NAFTIN is indicated for the treatment of tinea pedis, tinea cruris, and tinea corporis.

Q: How is NAFTIN distributed in the U.S. market?

A: NAFTIN is primarily distributed through U.S. outpatient retail pharmacies, with a smaller percentage going to non-retail and mail-order/specialty pharmacies.

Q: Is NAFTIN safe for pediatric use?

A: Yes, clinical trials have shown that NAFTIN is safe and effective for pediatric patients aged 2 years and older, with no significant increase in adverse events.

Q: What factors influence the pricing of NAFTIN?

A: Pricing is influenced by fluctuations in market demand and supply, as well as the availability of co-pay savings programs.

Q: How does the regulatory environment impact NAFTIN’s financial trajectory?

A: Regulatory approvals and continuous monitoring of adverse events are crucial for maintaining market confidence and ensuring the drug’s continued financial viability.

Sources

1. FDA: Naftin (Naftifine hydrochloride) - FDA[1]
2. Globenewswire: NEWTON GOLF Company Provides Preliminary Financial Results[2]
3. Roshkastudios: Why Is Naftin So Expensive[3]
4. FDA: CENTER FOR DRUG EVALUATION AND RESEARCH[4]
5. NAFTIN.com: HCP Co-Pay Assistance - NAFTIN.com[5]