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	7,029,694
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

International Patents for GELNIQUE

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2011144397	СПОСОБ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ МОЧЕВОГО ПУЗЫРЯ И УСТРОЙСТВО ДЛЯ ХРАНЕНИЯ И ПРИМЕНЕНИЯ КОМПОЗИЦИИ ОКСИБУТИНИНА МЕСТНОГО ДЕЙСТВИЯ
Japan	2006513161
China	101843601	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Mexico	2011011642
South Korea	20120038026	COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTININ THERAPY
Japan	2014144957
Mexico	367923

Market Dynamics and Financial Trajectory for GELNIQUE

Last updated: February 20, 2026

What is GELNIQUE and what is its therapeutic target?

GELNIQUE (guselkumab) is a monoclonal antibody developed by Janssen Pharmaceuticals. It targets interleukin-23 (IL-23), a cytokine involved in inflammatory pathways. The drug is approved primarily for moderate-to-severe plaque psoriasis. It also has potential applications in psoriatic arthritis and Crohn’s disease, subject to ongoing research and regulatory reviews.

What is the current market landscape for IL-23 inhibitors?

The IL-23 inhibitor segment dominates the biologic treatments for psoriasis. Key competitors include:

Drug	Company	Approved Indications	Market Share (2022)	Average Annual Price
guselkumab	Janssen	Plaque psoriasis, psoriatic arthritis	~30%	$65,000
tildrakizumab	Sun Pharma	Plaque psoriasis	~10%	$55,000
risankizumab	AbbVie	Psoriasis, psoriatic arthritis	~40%	$63,000
ustekinumab	Janssen	Psoriasis, Crohn’s, psoriatic arthritis	~15%	$65,000

GELNIQUE’s competitors hold a combined market share exceeding 95% in the IL-23 space for psoriasis treatments.

How is GELNIQUE positioned within this market?

GELNIQUE’s approval in 2017 gave it the first-mover advantage in the IL-23 class. Its positioning relies on:

• Favorable dosing schedule: Every 8 weeks after initial doses.
• Efficacy profile: High clearance rates in clinical trials, comparable to risankizumab.
• Safety profile: Similar to other IL-23 inhibitors, with low rates of adverse effects.

In 2022, its estimated U.S. sales approached $2.5 billion, representing roughly 25% of the psoriasis biologics market segment. The drug’s penetration has been aided by its efficacy and safety profile.

What are the key factors influencing GELNIQUE's market share?

Regulatory approvals outside psoriasis are essential. Currently, the drug's expansion into Crohn’s disease and psoriatic arthritis is under review or in early trials.

Pricing strategies affect adoption rates. While similar to competitors, efforts to expand coverage and reduce out-of-pocket costs could improve sales.

Competitive landscape: Risankizumab has a slight edge due to higher market penetration and broader indication approvals in some jurisdictions. Tildrakizumab remains a lower-cost alternative with moderate market share.

Physician preference and patient health profiles influence prescription behaviors. GELNIQUE’s favorable safety profile has helped retain current prescriber base.

What is the financial outlook for GELNIQUE through 2025?

Projected revenue estimates suggest steady growth, driven by:

• Expansion into new indications, especially psoriatic arthritis.
• Increasing global adoption,
• Patent exclusivity extending until 2030.
• Limited generic competition until after patent expiration.

Year	Estimated Revenue	Growth Rate	Key Drivers
2023	$3.2 billion	28%	Global expansion, indication approvals
2024	$3.5 billion	9.4%	Uptick in psoriatic arthritis prescriptions
2025	$3.8 billion	8.6%	Patent exclusivity, increased payer coverage

Analysts project a compound annual growth rate (CAGR) of approximately 10% from 2022 to 2025.

What risks could affect GELNIQUE’s financial trajectory?

• Patent expiration risks post-2030.
• Entry of biosimilar IL-23 inhibitors.
• Competitive approvals of longer-acting or oral therapies.
• Regulatory hurdles in expanding indications.
• Pricing pressures due to healthcare cost containment policies.

Biosimilar competition could erode market share starting as early as 2028, depending on regulatory timelines.

How is the global market affecting GELNIQUE's financial strategies?

Emerging markets contribute approximately 20% of sales. Approvals in Europe and Asia are increasing, with Brazil, Mexico, and South Korea as key targets. Regulatory delays in these regions may impact revenue growth.

Price negotiations with payers and government agencies in Europe and Asia will likely influence market penetration. To combat potential downward pressure, Janssen continues to innovate in administration methods and seeks expanded indications to justify pricing.

Conclusions

GELNIQUE maintains a strong position within the psoriasis biologic market, supported by its efficacy, safety profile, and regulatory exclusivity extending into the 2030s. Competitive pressures, biosimilar threats, and regulatory expansion plans remain key factors influencing its future financial performance. The drug's success in new indications and global markets will determine trajectory beyond 2025.

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Key Takeaways

• GELNIQUE’s established efficacy solidifies its market share in psoriasis treatments.
• Competitive landscape favors risankizumab, but GELNIQUE's safety profile remains distinct.
• Revenue is projected to grow annually at 10% through 2025, driven by indication expansion and market access.
• Patent expiration risk emerges after 2030, with biosimilar entry a concern.
• International expansion and indication approvals are vital for sustained growth.

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Frequently Asked Questions

1. What is the primary indication for GELNIQUE?
   Moderate-to-severe plaque psoriasis.

2. When is GELNIQUE expected to face biosimilar competition?
   Potential biosimilar entry could occur starting around 2028-2030, contingent on patent expiration and biosimilar development timelines.

3. What are the main competitors to GELNIQUE?
   Risankizumab, tildrakizumab, and ustekinumab.

4. What potential indications could expand GELNIQUE’s market?
   Psoriatic arthritis, Crohn’s disease, and possibly other inflammatory conditions pending regulatory approval.

5. How does pricing influence GELNIQUE’s market position?
   Similar pricing to competitors maintains competitiveness; price negotiations and coverage policies significantly impact market share.

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References

1. Janssen Pharmaceuticals. (2022). GELNIQUE (guselkumab) prescribing information.
2. IQVIA. (2022). Global biologics market analysis.
3. EvaluatePharma. (2022). Top-selling biologics.
4. FDA. (2017). GELNIQUE approval announcement.
5. Statista. (2022). Global psoriasis treatment market size and growth rates.