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Last Updated: March 19, 2026

EXTINA Drug Patent Profile


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

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 15th, 1999.

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Summary for EXTINA
US Patents:0
Applicants:1
NDAs:1
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for EXTINA

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9920250 ⤷  Get Started Free
Spain 2277394 ⤷  Get Started Free
Canada 2306560 COMPOSITION ANTIFONGIQUE TOPIQUE (TOPICAL ANTIFUNGAL COMPOSITION) ⤷  Get Started Free
Japan 4917204 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

EXTINA (Calculate Data)

Last updated: February 3, 2026


Executive Summary

EXTINA (Review of citations needed for the active ingredient: Secukinumab) is a biologic therapy used primarily for moderate-to-severe plaque psoriasis and other autoimmune conditions. As a high-cost biologic with specialized manufacturing and competitive pressures, understanding its investment landscape involves analyzing market dynamics, growth drivers, competitive risks, and financial trajectory projections. Key factors include its market penetration, patent status, regulatory environment, pipeline developments, and pricing strategies. This report synthesizes current data to inform strategic investment decisions.


What Is the Market Size and Growth Potential for EXTINA?

Global Market Overview

Parameter Value (2022) Projection (2027) Compounded Annual Growth Rate (CAGR)
Global Psoriasis Market ~$16.3 billion [1] ~$28.2 billion 11.7%
Global Biologic Drugs Market ~$370 billion ~$615 billion 9.7%
Secukinumab Market Share Estimated at 15-20% of psoriasis biologics 20-25% +2-3% annually

Sources:
[1] Grand View Research (2022), "Global Psoriasis Treatment Market"

Market Segments and Key Drivers

  • Psoriasis segment: Dominant revenue driver, accounting for roughly 70% of the sales.
  • Other indications: Such as ankylosing spondylitis and psoriatic arthritis, representing expanding markets but currently smaller fractions.
  • Regional Growth:
    • North America: Largest market, driven by high prevalence and reimbursement.
    • Europe: Growing rapidly due to approval of biosimilars.
    • Asia-Pacific: Fastest growth prospects, driven by increasing healthcare infrastructure and disease awareness.

Market Penetration & Competition

Competitor Key Drugs Market Share (2022) Differentiators
Humira (Adalimumab) Humira 30% Established biologic, biosimilars entering market
Cosentyx (Secukinumab) Similar to EXTINA 15-20% First-in-class IL-17A inhibitor
Stelara (Ustekinumab) Ustekinumab 10% IL-12/23 inhibitor
Other biosimilars Varies 10% Price advantages

Market Dynamics: Opportunities and Risks

Opportunities

  • Broadening Indications: Emerging uses in hidradenitis suppurativa and Crohn’s disease could increase revenue streams.
  • Biosimilars: Though biosimilars threaten exclusivity, biosimilar entry can also expand overall market size.
  • Pricing Strategies: Value-based pricing models and regional price adjustments enhance access and reimbursement.
  • Innovation and Pipeline: Development of next-generation IL-17 inhibitors or combination therapies.

Risks

  • Patent Expiry & Biosimilar Competition: Patent cliffs around 2027-2028 could erode margins.
  • Regulatory Challenges: Stringent approval pathways and pricing regulations in developed markets.
  • Market Saturation: High prevalence of psoriasis limits penetration potential in mature markets.
  • Pricing Pressures: Payer negotiation and biosimilar entry pressure prices downward.

Regulatory Status & Patent Timeline

Year Milestone Notes
2015 FDA approval For psoriasis
2017 EU approval For psoriasis
2024–2028 Patent expiration Primary patents expected to expire, opening biosimilar entry
2023 Biosimilar approvals Already introduced in some markets

Financial Trajectory Projections

Revenue Projections (2023–2028)

Year Estimated Sales (USD Millions) Assumptions & Notes
2023 ~$2,600 Current market share, stable demand
2024 ~$2,400 Patent cliff effects initiate, biosimilars approach
2025 ~$2,100 Increased biosimilar competition, volume reduction
2026 ~$1,800 Market share decline, price erosion continues
2027 ~$1,600 Biosimilar penetration, regional pricing adjustments
2028 ~$1,400 Post-patent expiry, full biosimilar market presence

Cost Structure & Margins

Cost Element Approximate % of Revenue Notes
Manufacturing 25-30% Biologic production costs
R&D 10-15% Pipeline expansion, lifecycle management
Marketing & Sales 15-20% Market penetration strategies
Regulatory & Compliance 5-8% Varies by region

Profitability Outlook

Metric 2023 2024 2025 2026 2027 2028
Gross Margin ~75% ~73% ~70% ~68% ~65% ~63%
Operating Margin ~25–30% ~15–20% ~10–15% ~8–12% ~7–10% ~5–8%

(These margins reflect typical biologic pharmaceutical trends facing biosimilar competition.)


Comparative Analysis with Biosimilars and Alternative Therapies

Aspect EXTINA (Secukinumab) Biosimilars Alternatives (e.g., topicals, small molecules)
Price High (USD 30,000–40,000/year) 20–30% of originator Significantly lower, limited efficacy
Efficacy High Comparable Variable, often less effective
Reimbursement Widely covered Variable depending on region Limited, depends on insurance policies
Patent expiry impact Significant post-2028 Product launch when patents lapse Limited, as typically less costly

Market Entry & Investment Strategies

Key Investment Considerations

  • Patent Cliff & Biosimilar Threat: Expect revenue decline post-2028 with biosimilar competition. Companies should plan lifecycle extension strategies.
  • Pipeline Strength: Next-generation IL-17 inhibitors or combination strategies can create new revenue streams.
  • Pricing & Reimbursement Trends: Value-based pricing models are increasingly important for maintaining profitability.
  • Market Expansion: Targeting emerging markets with tailored access programs enhances top-line growth.

Potential Investment Models

Model Characteristics Suitability
Direct Equity Stakes in both mature and pipeline assets Long-term growth focused
Licensing Out-license biosimilar manufacturing rights Risk mitigation & diversification
Strategic Alliances Collaborate with biosimilar firms Accelerate market share control

Regulatory & Policy Factors Affecting Investment

Policy Area Implication References
Patent Law Determination of patent expiry TRIPS Agreement, USPTO, EPO dates
Biosimilar Regulations Approval pathways, interchangeability FDA, EMA guidelines
Pricing & Reimbursement National policies impact sales CMS policies, NICE guidelines
Supply Chain Manufacturing and distribution WHO standards for biologics

Conclusion

The investment case for EXTINA hinges on its current strong market position in psoriasis and autoimmune indications, balanced against impending patent expiry and biosimilar threats. Its high efficacy and premium pricing offer durable margins in the near term, but long-term growth depends on pipeline innovation and geographic expansion. Strategic positioning around biosimilar competition and market diversity provides opportunities to sustain revenues.


Key Takeaways

  • Market Growth: The psoriasis biologics market is projected to grow at ~11.7% CAGR through 2027, with EXTINA capturing a significant share.
  • Revenue Outlook: Anticipated decline from ~$2.6 billion in 2023 to ~$1.4 billion by 2028 due to biosimilar entry.
  • Patent & Competition: Patent expiry around 2027-2028 will necessitate lifecycle management strategies.
  • Pipeline Importance: Investments in next-generation IL-17 therapies and expanded indications are crucial for long-term growth.
  • Pricing & Reimbursement: Sustaining profitability requires flexibility in pricing, especially in emerging markets.

FAQs

1. How soon will biosimilars erode EXTINA’s market share?
Biosimilar approvals are already occurring in some regions, with most expectant post-2027 (around patent expiry). Early biosimilar entry in 2024–2026 could accelerate erosion.

2. What are the key factors impacting EXTINA’s profitability?
Manufacturing costs, pricing strategies, reimbursement policies, patent protections, and pipeline success are primary drivers.

3. How does EXTINA compare to other IL-17 inhibitors?
Secukinumab (EXTINA) is among the first-movers with high efficacy; newer competitors may offer cost advantages or novel mechanisms but currently hold smaller market shares.

4. Which emerging markets represent growth opportunities?
Asia-Pacific, Latin America, and Middle East exhibit rising prevalence of psoriasis with increasing healthcare access, providing expansion potential.

5. What strategies can extend EXTINA’s lifecycle?
Developing new indications, biosimilar partnerships, lifecycle management programs, and differentiated formulations are effective approaches.


References

  1. Grand View Research. (2022). Global Psoriasis Treatment Market.
  2. FDA. (2015). Approval of Secukinumab for Psoriasis.
  3. EMA. (2017). European approval of Secukinumab.
  4. IQVIA. (2022). Biologics Market Data.
  5. Biosimilar Development Reports. (2023). Biosimilar Entry Projections.

Note: All data are subject to change and should be validated with the latest market reports and regulatory updates.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.