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-one 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:	2,281
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	7,553,835
Rising	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	8,026,238

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
European Patent Office	1692951
Japan	4917204
World Intellectual Property Organization (WIPO)	9920250

EXTINA Market Analysis and Financial Projection

Last updated: April 25, 2026

EXTINA: Market Dynamics and Financial Trajectory

EXTINA is marketed as a topical antifungal product containing sertaconazole nitrate (brand variants appear across geographies). Its commercial path is driven by a narrow therapeutic niche (superficial mycoses), patent and exclusivity realities that differ by country, and a competitive set dominated by generic azole creams and combination products. The financial trajectory depends more on pricing power and distribution coverage than on incremental clinical differentiation.

What is EXTINA’s market niche and how does that shape demand?

EXTINA sits in the dermatology/topical antifungal segment, where buying behavior is dominated by:

• Indication-based use: tinea/candidal/dermatophyte skin conditions, typically treated in short courses.
• Switchability: azole-based topical antifungals are pharmacologically similar, so channel partners and prescribers can switch brands at low friction once price and availability change.
• Seasonality: demand often tracks warmth and humidity cycles in many regions (notably affecting athlete’s foot and tinea patterns).

Business implication: EXTINA’s volume growth usually requires either (1) channel expansion, (2) promotions, or (3) payer/retailer acceptance that keeps the product price competitive against generics.

Who competes in the same practical space?

Within topical antifungals, competitors typically include:

• Generic and branded imidazoles and triazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole, terbinafine where available).
• Other branded antifungal creams/sprays that use similar consumer messaging (itch relief, fast symptom control).
• Combination dermatology regimens (where present) that compete for the same shelf space.

Market dynamic: when generics enter, the segment shifts quickly from brand-led to price-led. That transition generally compresses gross margin and increases marketing spend per incremental prescription or purchase.

How does pricing and reimbursement typically evolve for topical antifungals?

Topical antifungals are frequently characterized by:

• Low payer complexity in many markets: out-of-pocket purchases are common for OTC or loosely reimbursed products.
• Price elasticity: patients respond to price promotions at pharmacy chains and e-commerce.
• Retail substitution: pharmacists can recommend alternates with comparable therapeutic intent.

Financial implication: EXTINA’s financial trajectory tends to show:

• Stable revenue while brand position is maintained,
• Margin compression as generics gain shelf share,
• Revenue volatility when promotions change or when supply/distribution changes.

What are the likely exclusivity and IP drivers behind the competitive timeline?

EXTINA’s economic profile is constrained by the IP characteristics typical of topical antifungals and the likely role of the active ingredient (sertaconazole nitrate) in the branded lifecycle. Country-by-country outcomes generally follow one of two paths:

1. Branded period then generic erosion if the underlying compound or formulation IP protection ends and local generics launch.
2. Sustained branded presence if the market has:
   • limited generic penetration,
   • strong local regulatory/registration barriers,
   • or channel lock-in that preserves pricing.

Practical consequence: Without a late-stage new formulation breakthrough or a defensible combination regimen, EXTINA’s longer-term revenue tends to track market pricing and penetration rather than new patent-secured growth.

Market growth levers for EXTINA

EXTINA’s upside case in mature topical antifungal categories usually comes from execution, not biology:

• Formulation and strength differentiation: if variants exist (cream vs other topical forms), they can slightly change channel pull.
• Regulatory expansion by product registration: entering additional countries can add revenue even when the core market is mature.
• Distribution density: national pharmacy coverage and select e-commerce placement.
• Brand economics: trade terms with wholesalers and pharmacy chains determine whether EXTINA stays on shelf at a competitive net price.

Where this shows up in financials: revenue can grow without major margin expansion if growth is promotion-funded or if trade discounts increase.

What does the financial trajectory usually look like for a branded topical azole?

A typical branded topical antifungal pattern is:

• Early branded growth: share build after launch, driven by prescriber confidence and pharmacy stocking.
• Plateau: once growth saturates and generics begin to appear, volume stabilizes.
• Share erosion and margin drop: as pricing competition increases and wholesalers demand lower net prices.
• Stabilization or decline: depends on whether the brand retains differentiation (formulation, availability, or local regulatory positioning).

For EXTINA, the business risk is the category’s rapid generic substitution. The upside case is maintaining net price and channel placement longer than peers through targeted positioning and consistent supply.

Financial outlook: key drivers to monitor in EXTINA P&L terms

Even when public financials are not available at the product level, EXTINA’s financial trajectory can be inferred by tracking:

Revenue drivers

• Unit movement (prescriptions or OTC sales) by geography
• Channel mix shift (pharmacy vs hospital vs e-commerce)
• Launch timing of generic substitutes in each market

Margin drivers

• Net pricing vs list pricing (trade discounts and volume rebates)
• Promotion intensity (higher markdowns after generic entry)
• SKU rationalization and supply costs

Risk drivers

• Generic entry waves that trigger rapid shelf price resets
• Regulatory label changes that affect indications, pack sizes, or substitution rules
• Distribution outages that cause temporary revenue gaps and long-term share loss

Scenario view: market share and revenue trajectory (mechanical)

Below is a directional framework consistent with topical antifungal category dynamics. It links market events to likely revenue and margin outcomes.

Market event for sertaconazole topical	Likely effect on EXTINA units	Likely effect on net price	Net revenue trend	Margin trend
Limited generic penetration, stable pharmacy stocking	Stable to modest growth	Stable	Flat to up	Stable
Generic azole entry into major retail chains	Down	Down	Down or flat	Down
Promotion-led defense (increased trade spend)	Up short term	Down net	Flat to up	Down
Expansion to additional countries/registrations	Up	Mixed	Up	Mixed

What signals typically indicate EXTINA is losing pricing power?

For branded topical antifungals, pricing power loss tends to show up through:

• Higher promotional frequency (more frequent discounts at the pharmacy)
• Shift to smaller pack sizes or increased reliance on trade terms
• Faster share decay after generic announcements compared with prior competitor launches
• E-commerce price convergence toward generic SKUs

Financial takeaway: once convergence starts, revenue can keep moving only if unit volume holds, which often gets harder once patient and pharmacist substitution becomes routine.

What signals typically indicate stabilization or recovery?

Stabilization or recovery is more likely when:

• Competition remains fragmented (multiple generics without dominant low-price leader)
• EXTINA maintains a clean supply chain and avoids stockouts
• There is differentiation in pack size, vehicle, or user experience that sustains preference in pharmacy workflow
• Brand support aligns with channel economics (trade terms are sufficient to keep shelf visibility)

Key Takeaways

• EXTINA operates in a high-switchability topical antifungal niche, where demand is short-course and easily substituted.
• The core market dynamic is generic-driven price compression after entry into key geographies.
• EXTINA’s financial trajectory is typically governed by channel density, net pricing after trade discounts, and competition timing, not by long-cycle R&D breakthroughs.
• Upside depends on execution (distribution, regulatory expansion, shelf retention) and on resisting net price erosion through favorable trade economics.
• The central risk is rapid margin compression once generics gain mainstream pharmacy and e-commerce shelf dominance.

FAQs

1) Is EXTINA’s revenue growth likely to be driven by new clinical evidence?

No. For topical antifungals, commercial growth usually follows channel access and pricing strategy rather than new clinical differentiation.

2) What most often drives revenue declines in brands like EXTINA?

Generic entry and retail price convergence, which reduce net pricing and increase substitution at the point of sale.

3) Does EXTINA’s performance depend more on prescriptions or OTC purchasing?

It depends on the country, but in many markets pharmacy and OTC dynamics dominate for topical antifungals, making pricing and availability decisive.

4) Can EXTINA maintain margins after generics enter?

It can for a period if it keeps net price and avoids heavy promotion-funded share defense, but margins typically trend down without differentiation or favorable channel positioning.

5) What are the earliest financial warning signs of share loss?

Rising promotional intensity, faster sell-through declines in major retail channels, and accelerating e-commerce price convergence toward generic equivalents.

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References

[1] APA: Market research and product listings typically list EXTINA as a sertaconazole nitrate topical antifungal in various geographies; specific financial performance is usually reported only at company level rather than product-level in public sources.