GELNIQUE 3% Drug Patent Profile

When do Gelnique 3% patents expire, and when can generic versions of Gelnique 3% launch?

Gelnique 3% is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in GELNIQUE 3% 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.

Summary for GELNIQUE 3%

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GELNIQUE 3%
DailyMed Link:	GELNIQUE 3% at DailyMed

Recent Clinical Trials for GELNIQUE 3%

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

Sponsor	Phase
Academic and Community Cancer Research United	Phase 3
National Cancer Institute (NCI)	Phase 3
University of Colorado, Denver	N/A

See all GELNIQUE 3% clinical trials

US Patents and Regulatory Information for GELNIQUE 3%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011		DISCN	Yes	No

Expired US Patents for GELNIQUE 3%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011

EU/EMA Drug Approvals for GELNIQUE 3%

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Kentera (previously Oxybutynin Nicobrand)	oxybutynin	EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.	Authorised	no	no	no	2004-06-15

International Patents for GELNIQUE 3%

See the table below for patents covering GELNIQUE 3% around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20050106508
Canada	2515426	UTILISATIONS ET FORMULES POUR L'APPLICATION TRANSDERMIQUE OU PAR VOIE TRANSMUQUEUSE D'AGENTS ACTIFS (USES AND FORMULATIONS FOR TRANSDERMAL OR TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS)
Portugal	1280486
Norway	20052625
New Zealand	539562	Compositions and methods for transdermal oxybutynin therapy
Austria	534373

GELNIQUE 3% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GELNIQUE 3%

Introduction to GELNIQUE 3%

GELNIQUE 3% is a topical gel formulation of oxybutynin, approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency. Developed by Antares Pharma and marketed by Watson Pharmaceuticals (now part of Teva Pharmaceutical Industries), this product has carved a niche in the OAB treatment market.

Clinical Efficacy and Safety

The efficacy and safety of GELNIQUE 3% were evaluated in a randomized, double-blind, placebo-controlled, multicenter 12-week study. The study showed that patients treated with the 84 mg/day dose experienced a statistically significant decrease in urinary incontinence episodes, daily urinary frequency, and an increase in urinary void volume compared to the placebo group[1][4].

Market Dynamics

Market Size and Growth

The overactive bladder market, in which GELNIQUE 3% operates, is substantial. In 2020, the OAB market across eight major markets was valued at $2.2 billion. The market is expected to grow driven by factors such as the increasing prevalence of OAB due to aging populations and rising obesity, as well as the introduction of new treatments[3].

Competitive Landscape

GELNIQUE 3% competes with other OAB treatments, including oral medications like VESIcare, Myrbetriq, and Toviaz. However, its unique transdermal delivery system, which reduces side effects common with oral oxybutynin products, such as dry mouth and constipation, offers a competitive advantage[4].

Barriers to Growth

Despite its efficacy, the OAB market faces several barriers, including stigma and misinformation surrounding OAB, which deter patients from seeking medical help. Additionally, poor persistence and adherence to drug therapy are significant challenges. These factors are expected to persist over the forecast period, potentially impacting the growth of GELNIQUE 3% and other OAB treatments[3].

Financial Performance

Launch and Initial Impact

GELNIQUE 3% was launched in 2012, following its FDA approval in December 2011. The launch was seen as a strategic move by Watson Pharmaceuticals to strengthen its position in the urology market, particularly in the treatment of OAB[4].

Revenue Contribution

While specific revenue figures for GELNIQUE 3% are not publicly disclosed, the product is part of the broader urology portfolio of its parent company. The overall urology market, including other treatments like JELMYTO by UroGen Pharma, has shown significant growth. For instance, UroGen Pharma reported a 30% growth in net product revenue for JELMYTO in the third quarter of 2023 compared to the same period in 2022, indicating a robust market for urological treatments[2].

Patient and Prescriber Preferences

Convenience and Efficacy

GELNIQUE 3% offers patients the convenience of once-daily dosing using a simple, precise metered-dose pump. This convenience, coupled with its efficacy in reducing OAB symptoms, makes it an attractive option for both patients and prescribers. The product's early treatment effect and improved efficacy over time further enhance its appeal[4].

Regulatory and Developmental Landscape

Approval and Post-Marketing Surveillance

GELNIQUE 3% was approved based on a comprehensive clinical trial program that included a 12-week double-blind study followed by a 24-week open-label safety extension. The safety profile of the product has been continuously monitored, with no significant new safety concerns identified post-marketing[1].

Future Outlook

Market Expansion and Competition

The OAB market is expected to evolve with the introduction of new treatments, including pipeline agents like Bayer’s P2X purinoceptor 3 (P2RX3) antagonist Eliapixant and Urovant Sciences’ gene therapy URO-902. However, GELNIQUE 3%’s unique delivery system and established efficacy profile position it well to maintain its market share[3].

Key Takeaways

• Clinical Efficacy: GELNIQUE 3% has demonstrated significant reductions in urinary incontinence episodes, daily urinary frequency, and an increase in urinary void volume.
• Market Dynamics: The OAB market is growing due to increasing prevalence and new treatment options, but faces challenges like stigma and poor adherence.
• Financial Performance: While specific revenue figures are not disclosed, the product contributes to the overall growth of the urology market.
• Patient and Prescriber Preferences: The convenience and efficacy of GELNIQUE 3% make it a preferred option.
• Regulatory and Developmental Landscape: The product has a strong approval basis and ongoing safety surveillance.

FAQs

1. What is GELNIQUE 3% used for? GELNIQUE 3% is used for the treatment of overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency.

2. How is GELNIQUE 3% administered? GELNIQUE 3% is administered as a clear, odorless topical gel using a metered pump dispenser, once daily.

3. What are the key benefits of GELNIQUE 3%? The key benefits include significant reductions in urinary incontinence episodes, daily urinary frequency, and an increase in urinary void volume, with fewer side effects compared to oral oxybutynin products.

4. What are the market challenges for GELNIQUE 3%? The market challenges include stigma and misinformation surrounding OAB, poor persistence and adherence to drug therapy, and competition from other OAB treatments.

5. Is GELNIQUE 3% safe? GELNIQUE 3% has been evaluated in clinical trials and has a favorable safety profile, although it is flammable and patients should avoid open fire or smoking until the gel has dried[1][4].

Cited Sources

1. GELNIQUE 3% (oxybutynin) gel 3% - FDA Label[1]
2. UroGen Pharma Reports Third Quarter 2023 Financial Results[2]
3. Overactive Bladder: Global Drug Forecast and Market Analysis to 2030[3]
4. Watson and Antares Announce the Introduction of Gelnique 3%[4]