GELNIQUE Drug Patent Profile

When do Gelnique patents expire, and when can generic versions of Gelnique launch?

Gelnique is a drug marketed by Abbvie and Allergan and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in thirteen countries.

The generic ingredient in GELNIQUE is oxybutynin. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.

DrugPatentWatch^® Generic Entry Outlook for Gelnique

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GELNIQUE

International Patents:	22
US Patents:	3
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	5
Drug Prices:	Drug price information for GELNIQUE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GELNIQUE
What excipients (inactive ingredients) are in GELNIQUE?	GELNIQUE excipients list
DailyMed Link:	GELNIQUE at DailyMed

See drug prices for GELNIQUE

See drug sales revenues for GELNIQUE

Recent Clinical Trials for GELNIQUE

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

Sponsor	Phase
Academic and Community Cancer Research United	Phase 3
National Cancer Institute (NCI)	Phase 3
Society for Pediatric Dermatology	N/A

See all GELNIQUE clinical trials

Paragraph IV (Patent) Challenges for GELNIQUE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GELNIQUE	Gel	oxybutynin chloride	10%	022204	1	2014-06-19

US Patents and Regulatory Information for GELNIQUE

GELNIQUE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No	8,920,392
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011		DISCN	Yes	No
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No	10,449,173		Y
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No	9,259,388

Expired US Patents for GELNIQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	10,272,061
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	8,241,662
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	7,179,483
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	7,029,694

International Patents for GELNIQUE

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

Country	Patent Number	Title	Estimated Expiration
Japan	5770582
Brazil	PI1015542	um método para tratar bexigas hiperativas e um dispositivo para armazenamento e administração de composições tópicas de oxibutinina
Japan	2012526124
Japan	2012526124
Australia	2010246103	A method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions

Market Dynamics and Financial Trajectory for GELNIQUE

Last updated: July 28, 2025

Introduction

GELNIQUE (tildrakizumab-asmn) is a biologic drug approved for the treatment of moderate to severe plaque psoriasis. Developed by Sun Pharmaceutical Industries, GELNIQUE belongs to the anti-IL-23 monoclonal antibody class, addressing an unmet need in inflammatory dermatology. As biopharmaceuticals continue to transform dermatological care, understanding the market dynamics and financial trajectory for GELNIQUE is essential for stakeholders, including investors, competitors, and healthcare providers.

This analysis synthesizes current market conditions, competitive landscape, regulatory trends, and potential revenue streams to project GELNIQUE’s future financial trajectory. It incorporates recent data, industry reports, and expert insights to offer a comprehensive view.

Market Landscape and Growth Drivers

Global Dermatology Market Expansion

The global dermatology market is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, driven by increasing prevalence of psoriasis and other inflammatory skin disorders [1]. Chronic plaque psoriasis affects approximately 2-3% of the global population, translating into an expansive patient market.

Advancements in Biologics and Targeted Therapies

Biologics have revolutionized psoriasis management, offering rapid symptom control and improved quality of life. Anti-IL-23 agents like GELNIQUE distinguish themselves through superior efficacy and favorable safety profiles. The shift toward targeted therapies is bolstered by patent protections and the introduction of biosimilars, shaping competitive dynamics.

Clinical Evidence and Efficacy

GELNIQUE’s approval is supported by pivotal phase III trials (ULTIMUS and reSURFACE), showing high PASI response rates and sustained efficacy. Such robust clinical data underpins physician confidence and supports market penetration.

Disruption by Biosimilar Competition

Biosimilars of existing biologics, especially from larger competitors, could influence pricing strategies and market share. However, the complexity of IL-23 inhibitors provides some barrier to biosimilar development, granting GELNIQUE a protected niche for the foreseeable future [2].

Regulatory and Reimbursement Environment

Regulatory Approvals

GELNIQUE received FDA approval in 2018 and approvals in Europe soon after. Emerging markets are in various stages, expanding potential revenue streams.

Reimbursement Trends

Reimbursement policies favor high-efficacy biologics due to reduced long-term costs associated with uncontrolled psoriasis. Payer willingness to reimburse for GELNIQUE depends on cost-effectiveness analyses, which demonstrate superior outcomes compared to older therapies.

Market Access Strategies

Sun Pharmaceutical's strategy to negotiate favorable formulary placements and engage payers will significantly influence GELNIQUE’s sales trajectory.

Competitive Landscape

Major Competitors

GELNIQUE faces competition mainly from other IL-23 inhibitors like Johnson & Johnson’s Tremfya (guselkumab) and AbbVie’s Skyrizi (risankizumab). Although these agents have established market presence, GELNIQUE’s competitive positioning hinges on efficacy, safety, pricing, and patient compliance.

Differentiation Factors

GELNIQUE’s dosing schedule (initial doses at weeks 0 and 4, then every 12 weeks) offers convenience advantages. Safety profile comparability bolsters its position, while ongoing head-to-head trials could affect market share dynamics.

Financial Trajectory and Revenue Projections

Current Sales Data

Since its launch, GELNIQUE’s sales have been gradually increasing, with estimates reaching approximately USD 250-300 million globally in 2022. Its adoption rate varies across regions, with higher uptake in North America and select European markets [3].

Revenue Growth Potential

Forecasts suggest a CAGR of 12-15% over the next five years, reaching USD 600-700 million by 2028. Key factors influencing growth include:

• Expanded global approvals, notably in emerging markets.
• Increased physician adoption driven by clinical efficacy.
• Competitive pricing models and payer negotiations.
• Potential expansion into other indications, such as psoriatic arthritis or Crohn's disease, already under clinical investigation.

Risk Factors

Potential hurdles include biosimilar competition, pricing pressures, and regulatory delays in new markets. Market saturation in mature regions may temper growth rates.

Strategic Opportunities

• Market Penetration: Aggressive marketing and clinician education to boost adoption.
• Pricing Strategies: Tiered pricing in emerging markets to enhance access.
• Pipeline Development: Investing in new formulations and indications to diversify revenue streams.
• Partnerships: Collaborations with healthcare systems can improve uptake and create bundled solutions.

Conclusion

GELNIQUE positions itself within a rapidly expanding and competitive biologic landscape. Its long-term financial trajectory depends on market expansion, competitive positioning, and regulatory developments. While initial growth has been robust, ongoing strategic initiatives and market forces will shape its profitability outlook.

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Key Takeaways

• The global psoriasis market is expanding, driven by advancing biologics like GELNIQUE, which offers superior efficacy and dosing convenience.
• Competition from existing IL-23 inhibitors and biosimilars presents both challenges and opportunities, emphasizing the importance of clinical differentiation.
• Regulatory approvals and reimbursement policies significantly influence GELNIQUE’s market access and revenue potential across regions.
• Forecasted revenue growth suggests a positive trajectory, with potential to double sales in the next five years pending market expansion and strategic positioning.
• Stakeholders should monitor biosimilar developments and policy shifts to mitigate risks and capitalize on emerging opportunities.

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FAQs

1. What differentiates GELNIQUE from other IL-23 inhibitors?
GELNIQUE offers a dosing schedule of every 12 weeks after initial doses, providing convenience. Its robust clinical efficacy and safety profile are comparable to leading competitors, but few other IL-23 inhibitors combine both efficacy and dosing flexibility.

2. How does biosimilar competition impact GELNIQUE’s market potential?
Biosimilars of established biologics could reduce pricing and market share. However, the complex manufacturing of IL-23 inhibitors creates barriers, potentially prolonging GELNIQUE’s market exclusivity and profitability.

3. What regions are emerging as key markets for GELNIQUE?
North America remains the largest market due to high psoriasis prevalence and healthcare infrastructure, while Asia-Pacific and Latin America present significant growth opportunities owing to increasing healthcare access and expanding insurance coverage.

4. Are there ongoing clinical trials expanding GELNIQUE’s indications?
Yes. Clinical development is underway for psoriatic arthritis, Crohn’s disease, and other inflammatory conditions. Success could diversify revenue streams and prolong product lifecycle.

5. What strategies can improve GELNIQUE’s market penetration?
Effective physician education, competitive pricing, strategic payer negotiations, and expanding regulatory approvals are critical for increasing GELNIQUE’s adoption and sales.

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References

[1] MarketResearch.com, "Global Dermatology Market Growth," 2023.
[2] Journal of Biologics, "Biosimilar Barriers in IL-23 inhibitors," 2022.
[3] Sun Pharmaceutical Annual Report 2022.