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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	5
Patent Applications:	1,757
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
University of Colorado, Denver	N/A

See all GELNIQUE clinical trials

Pharmacology for GELNIQUE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

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
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			Y
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No

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
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009

International Patents for GELNIQUE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2019011031	UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.)
Russian Federation	2311170	КОМПОЗИЦИИ ОКСИБУТИНИНА И СПОСОБЫ ЧРЕСКОЖНОЙ ТЕРАПИИ ОКСИБУТИНИНОМ (OXYBUTYNIN COMPOSITIONS AND METHODS FOR PERCUTANEOUS THERAPY WITH OXYBUTYNIN)
Norway	339626
South Korea	20120030078	A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS
Portugal	1280486
Canada	2406064	REDUCTION D'EPISODES INDESIRABLES ASSOCIES A UNE THERAPIE PAR L'OXYBUTYNINE (MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY)

GELNIQUE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GELNIQUE

Overview of GELNIQUE

GELNIQUE, developed by Antares Pharma and marketed by Watson Pharmaceuticals (now part of Teva Pharmaceutical Industries), is a topical gel formulation of oxybutynin chloride designed for the treatment of overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency. The product is available in two concentrations: 10% and 3% formulations.

Market Context of Overactive Bladder

The overactive bladder market is significant, with over 33 million Americans affected by the condition. The U.S. market for OAB treatments exceeds $2.0 billion annually, making it a lucrative segment within the pharmaceutical industry[2][3].

Market Size and Growth

The global OAB market was valued at $2.2 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of more than 2% from 2021 to 2030. The U.S. accounts for the largest share of this market, driven by a large prevalence population and high drug therapy costs[3][4].

Launch and Marketing of GELNIQUE

Initial Launch

GELNIQUE 10% was first launched in 2009 by Watson Pharmaceuticals. The marketing campaign focused on empowering patients, particularly active women, by highlighting the product's efficacy, ease of use, and excellent tolerability. This approach differentiated GELNIQUE from traditional OAB treatments that often emphasized the stigma associated with the condition[1].

Expansion with GELNIQUE 3%

In 2012, Watson and Antares introduced GELNIQUE 3%, which offered a lower concentration of oxybutynin chloride. This product was also delivered via a clear, odorless gel and utilized a metered pump dispenser for convenient dosing. The launch further solidified Watson's commitment to the urology market, especially in treating OAB[2].

Clinical Efficacy and Safety

Both GELNIQUE 10% and 3% have demonstrated significant clinical efficacy in reducing OAB symptoms. In Phase 3 trials, these formulations were superior to placebo in reducing incontinence episodes, urinary frequency, and increasing urine void volume. The transdermal delivery mechanism minimizes liver metabolism, resulting in lower side effects such as dry mouth and constipation compared to oral oxybutynin products[1][2].

Market Dynamics

Drivers of Growth

• Increasing Prevalence: The rising prevalence of OAB, particularly among aging populations and those with increasing obesity rates, drives market growth[3][4].
• New Therapies: The anticipated launch of emerging therapies with novel mechanisms of action, such as Bayer’s P2X purinoceptor 3 antagonist Eliapixant and Urovant Sciences’ gene therapy URO-902, is expected to boost the market[3][4].
• Convenience and Efficacy: Products like GELNIQUE, with their convenient dosing and reduced side effects, enhance patient compliance and satisfaction.

Barriers to Growth

• Stigma and Misinformation: Stigma and misinformation surrounding OAB deter patients from seeking medical help, affecting diagnosis and treatment rates[3][4].
• Generic Erosion: Patent expirations of key OAB drugs, such as VESIcare and Myrbetriq, can lead to generic competition and reduce market growth[3].
• Market Access Issues: Unaffordable pricing, market access, and reimbursement issues can hinder the adoption of new therapies[4].

Financial Trajectory

Revenue and Market Share

GELNIQUE, as part of Watson Pharmaceuticals' portfolio, contributes to the company's revenue in the urology segment. While specific revenue figures for GELNIQUE are not publicly disclosed, the overall OAB market growth and the product's clinical efficacy suggest a positive financial trajectory. The market share of GELNIQUE is influenced by its unique delivery mechanism and the strong marketing efforts by Watson Pharmaceuticals[1][2].

Competitive Landscape

The OAB market is competitive, with leading therapies like Myrbetriq dominating the market. However, GELNIQUE's unique positioning as a topical gel with reduced side effects helps it maintain a significant market presence. The partnership between Watson and Antares has been crucial in leveraging their combined expertise to market GELNIQUE effectively[2][3].

Key Takeaways

• Market Growth: The OAB market is expected to grow due to increasing prevalence and the launch of new therapies.
• Clinical Efficacy: GELNIQUE has demonstrated strong clinical efficacy with reduced side effects.
• Marketing Strategy: The product's marketing focuses on empowering patients and highlighting its convenience and tolerability.
• Barriers: Stigma, misinformation, and market access issues can impact market growth.
• Financial Trajectory: GELNIQUE contributes positively to Watson Pharmaceuticals' revenue in the urology segment.

FAQs

What is GELNIQUE used for?

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

How is GELNIQUE administered?

GELNIQUE is administered as a topical gel, applied once daily to the thigh, abdomen, upper arm, or shoulder.

What are the benefits of GELNIQUE over oral OAB medications?

GELNIQUE's transdermal delivery reduces liver metabolism, resulting in lower side effects such as dry mouth and constipation compared to oral oxybutynin products.

Who are the key players in the OAB market?

Key players include Allergan, Astellas, Pfizer, Urovant Sciences, Bayer, Taiho Pharmaceuticals, and Kyorin Pharmaceuticals.

What are the main drivers of the OAB market growth?

The main drivers include increasing prevalence of OAB, anticipated launch of emerging therapies, and rising healthcare spending.

What are the barriers to the growth of the OAB market?

Barriers include stigma and misinformation surrounding OAB, generic erosion of key drugs, and market access and reimbursement issues.

Sources

1. Watson Pharmaceuticals, Inc. Launches GELNIQUE(TM) (oxybutynin chloride) gel 10% - BioSpace
2. Watson and Antares Announce the Introduction of Gelnique 3% - PR Newswire
3. Overactive Bladder: Global Drug Forecast and Market Analysis to 2030 - GlobalData
4. Overactive Bladder Market to Grow Rapidly at a Considerable CAGR During the Forecast Period (2023–2032) - GlobeNewswire