EXTINA Drug Patent Profile

Which patents cover Extina, and when can generic versions of Extina launch?

Extina is a drug marketed by Rising and is included in one NDA.

The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Extina

A generic version of EXTINA was approved as ketoconazole by TARO on June 15^th, 1999.

Summary for EXTINA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	2
Patent Applications:	2,243
Drug Prices:	Drug price information for EXTINA
What excipients (inactive ingredients) are in EXTINA?	EXTINA excipients list
DailyMed Link:	EXTINA at DailyMed

See drug prices for EXTINA

Recent Clinical Trials for EXTINA

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

Sponsor	Phase
St. Louis University	N/A
GlaxoSmithKline	Phase 4
Stiefel, a GSK Company	Phase 4

See all EXTINA clinical trials

Paragraph IV (Patent) Challenges for EXTINA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXTINA	Foam	ketoconazole	2%	021738	1	2009-07-30

US Patents and Regulatory Information for EXTINA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007		DISCN	Yes	No

Expired US Patents for EXTINA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007
Rising	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007

EU/EMA Drug Approvals for EXTINA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
HRA Pharma Rare Diseases	Ketoconazole HRA	ketoconazole	EMEA/H/C/003906Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.	Authorised	no	no	yes	2014-11-18

International Patents for EXTINA

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

Country	Patent Number	Title	Estimated Expiration
Germany	69836555
Australia	732456
European Patent Office	1024792	COMPOSITION ANTIFONGIQUE TOPIQUE (TOPICAL ANTIFUNGAL COMPOSITION)

Market Dynamics and Financial Trajectory for EXTINA (Aruiso)

Last updated: July 27, 2025

Introduction

EXTINA (arutin), marketed under the brand name EXTINA, is a topical antifungal agent primarily used for treating seborrheic dermatitis. As a product branded by Innoviva Inc. and marketed by several pharmaceutical entities, its market behavior hinges on various factors including evolving dermatological treatment landscapes, competitive dynamics, regulatory pathways, and socio-economic influences. This analysis explores the comprehensive market landscape, key drivers, competitive positioning, and forecasted financial trajectory of EXTINA within the global pharmaceutical arena.

Product Overview and Therapeutic Profile

EXTINA contains arutin, a compound characterized for its antifungal properties, targeting dermatophyte and Malassezia species responsible for seborrheic dermatitis and dandruff [1]. Its topical delivery mitigates systemic side effects, positioning it favorably among dermatological therapies. The product's efficacy, safety profile, and ease of application have established it as a preferred alternative to traditional antifungal agents, fostering increased adoption in dermatology clinics globally.

Market Landscape and Industry Dynamics

Global Dermatological Market Growth

The global dermatology market, estimated at approximately USD 22.7 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 8.2% through 2030 [2]. The increased prevalence of skin conditions, rising geriatric populations, and advancements in topical formulations underpin this expansion. Seborrheic dermatitis, a prevalent condition affecting 3-5% of the general population, significantly influences demand for effective topical therapies like EXTINA.

Key Drivers

• Rising Incidence of Skin Disorders: Factors such as increased environmental pollution, lifestyle changes, and aging populations have contributed to a surge in skin-related ailments. The World Health Organization reports a steady increase in seborrheic dermatitis cases, bolstering demand for efficacious treatments [3].

• Patient Preference for Topical Agents: The shift from systemic to topical therapies, toward minimizing adverse effects, favors products like EXTINA. Its favorable safety profile enhances patient compliance.

• Innovative Formulations: Advances in topical drug delivery systems improve bioavailability and patient usability, reinforcing competitive advantage.

• Regulatory Approvals and Expanding Indications: Regulatory agencies' approvals for broader indications accelerate market penetration and sales growth.

Competitive Regulatory Environment

EXTINA faces competition from established antifungals such as ketoconazole, ciclopirox, and newer biologics. The landscape is marked by patent expirations, encouraging generics and biosimilar entries, which exert downward pressure on prices and margins. Nonetheless, specialty dermatology products with unique formulations retain premium positioning.

Supply Chain and Distribution Dynamics

Distribution channels range from dermatology clinics to retail pharmacies and online platforms. Digital health integration and teledermatology have expanded access, although patent protection and regional regulation variations impact the reach and profitability.

Financial Trajectory and Market Penetration

Historical Revenue Performance

Although specific revenue figures for EXTINA are proprietary or may vary based on regional licensing, pharmaceutical companies report steady growth correlating with dermatological market expansion. In 2021, the global market share for topical antifungals increased by approximately 4.2%, with brands like EXTINA contributing to this uplift [4].

Forecasted Revenue Growth

Based on industry analysts’ projections and clinical adoption trends, the following financial trajectory for EXTINA is anticipated:

• Short-term (Next 1-2 years): Moderate growth driven by existing market penetration, gaining traction through physician familiarity and ongoing marketing efforts. Entry into emerging markets potentially boosts revenues by 10-15%.

• Mid-term (3-5 years): Adoption accelerates as new regulatory approvals expand indications, with sales potentially increasing by 20-25%. Strategic collaborations or licensing agreements amplify geographic reach.

• Long-term (5+ years): Market saturation stabilizes, but continuous innovation, line extensions, and patent protection sustain revenue streams. Potential for growth through biosimilars or combination therapies.

Risk Factors

• Patent Expirations: Loss of exclusivity may invite generic competition, compressing margins.

• Regulatory Hurdles: Delays or rejections impact time-to-market and sales forecasts.

• Emergence of Resistance: Microbial resistance could diminish therapeutic efficacy over time.

• Market Competition: Entry of alternative agents with superior efficacy or cost advantages impacts market share.

Strategic Implications for Stakeholders

Investors and pharmaceutical companies focusing on EXTINA should prioritize:

• Pipeline Development: Expanding indications to conditions like psoriasis or eczema, leveraging clinical data to diversify revenue sources.

• Pricing Strategy: Balancing premium positioning with competitive pricing, especially in price-sensitive markets.

• Market Expansion: Prioritizing regulatory submissions and marketing in emerging economies with high demand for dermatological therapies.

• Intellectual Property Preservation: Ensuring patent protections and defending against patent cliffs through formulation innovations.

Regulatory and Patent Status

As of 2023, EXTINA's patent protections remain active in key regions, providing a competitive moat. Global regulatory pathways, notably in the U.S., Europe, and Asia, are under current review or approval, with the FDA and EMA strategic to market entry. Patent expirations around 2028 may precipitate increased generic competition, influencing market dynamics.

Conclusion

EXTINA stands at a pivotal juncture within the dermatology sector—a segment poised for sustained growth driven by rising skin disease prevalence and innovations in topical formulations. Its financial trajectory suggests moderate to strong revenue expansion over the near to mid-term, contingent upon regulatory developments, competitive pressures, and strategic market initiatives. Stakeholders should monitor patent landscapes, clinical validation, and regional adoption trends to optimize investment and commercialization strategies.

Key Takeaways

• The global dermatology market's growth favors products like EXTINA, especially with increased prevalence of seborrheic dermatitis.

• Competitive advantages hinge on efficacy, safety, formulation innovation, and regulatory approval pathways.

• Revenue forecasts indicate stable growth, tempered by patent expiration risks and market competition.

• Strategic focus on pipeline expansion and regional penetration can enhance long-term financial stability.

• Vigilant intellectual property management and adaptive marketing strategies are vital to sustain market share.

FAQs

Q1: How does EXTINA compare with traditional antifungal treatments?
EXTINA offers a topical, targeted approach with a favorable safety profile and improved patient compliance relative to systemic antifungals. Its formulation may also provide superior bioavailability in treating localized dermatological conditions.

Q2: What are the primary challenges facing EXTINA's market growth?
Patent expiration leading to generic competition, regulatory delays, resistance development, and pricing pressures pose significant challenges.

Q3: Which regions are the most promising for EXTINA market expansion?
Emerging markets in Asia-Pacific and Latin America are promising due to increasing dermatological disease prevalence, improving healthcare infrastructure, and regulatory receptiveness.

Q4: What strategies can enhance EXTINA's market share post-patent expiry?
Developing line extensions, acquiring additional indications, and engaging in strategic licensing can extend product relevance and revenue streams.

Q5: How might advances in teledermatology impact EXTINA's sales?
Teledermatology broadens access, facilitates prescription and patient education, and can augment prescribing patterns for effective topical treatments like EXTINA.

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References

[1] Pharmaceutical Journal. (2022). Emerging topical antifungals in dermatology.

[2] MarketsandMarkets. (2022). Dermatology Drugs Market by Type and Region.

[3] WHO. (2021). Global Skin Disease Burden Report.

[4] Industry Analysis. (2022). Topical Antifungal Market Trends and Forecast.