Darifenacin hydrobromide - Generic Drug Details

What are the generic drug sources for darifenacin hydrobromide and what is the scope of patent protection?

Darifenacin hydrobromide is the generic ingredient in three branded drugs marketed by Macleods Pharms Ltd, Alembic, Aurobindo Pharma, Cipla, Jubilant Generics, Ph Health, Polygen Pharms, Torrent, Xiromed, and Abbvie, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for darifenacin hydrobromide. Nine suppliers are listed for this compound.

Summary for darifenacin hydrobromide

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	2
Patent Applications:	425
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for darifenacin hydrobromide
What excipients (inactive ingredients) are in darifenacin hydrobromide?	darifenacin hydrobromide excipients list
DailyMed Link:	darifenacin hydrobromide at DailyMed

Recent Clinical Trials for darifenacin hydrobromide

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

Sponsor	Phase
Université de Montréal	PHASE2
Oliver Blanchard	PHASE2
Toronto Rehabilitation Institute	Phase 4

See all darifenacin hydrobromide clinical trials

Pharmacology for darifenacin hydrobromide

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for darifenacin hydrobromide

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DARIFENACIN HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENABLEX	Extended-release Tablets	darifenacin hydrobromide	7.5 mg and 15 mg	021513	3	2008-12-22

US Patents and Regulatory Information for darifenacin hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Polygen Pharms	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	211045-001	Jan 6, 2020	AB	RX	No	No
Torrent	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	205209-001	Nov 17, 2016	AB	RX	No	No
Ph Health	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	091190-001	Mar 13, 2015		DISCN	No	No
Cipla	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207664-002	Sep 1, 2016	AB	RX	No	No

Expired US Patents for darifenacin hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004

EU/EMA Drug Approvals for darifenacin hydrobromide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
pharmaand GmbH	Emselex	darifenacin hydrobromide	EMEA/H/C/000554Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.	Authorised	no	no	no	2004-10-22

Market Dynamics and Financial Trajectory for Darifenacin Hydrobromide

Last updated: July 27, 2025

Introduction

Darifenacin hydrobromide, a selective M3 muscarinic receptor antagonist, is primarily prescribed for the management of overactive bladder (OAB) with symptoms such as urinary frequency, urgency, and incontinence. Its unique pharmacological profile and evolving regulatory landscape influence its market trajectory, making understanding the underlying market dynamics essential for industry stakeholders. This analysis examines the current market environment, regulatory status, competitive landscape, and future financial outlook for darifenacin hydrobromide.

Pharmacological Profile and Clinical Applications

Darifenacin demonstrates high selectivity for M3 receptors, which mediate bladder smooth muscle contraction, minimizing side effects such as dry mouth and constipation commonly associated with less selective anticholinergics like tolterodine or oxybutynin. Approved by the FDA in 2009 under the brand name Enablex (AbbVie), it remains a treatment option for adults suffering from OAB.

The drug's clinical efficacy in reducing urinary urgency and incontinence episodes contributes to steady demand among prescribers, especially in populations with contraindications to other antimuscarinics or in cases where side effects limit treatment adherence.

Market Dynamics

1. Regulatory Status and Approvals

As a branded medication, darifenacin has maintained exclusivity periods granted through patent protections. Its initial patent protection expired in various markets over the past decade, opening avenues for generic formulations. The availability of generic darifenacin hydrobromide has significantly influenced market dynamics, leading to price erosion and increased affordability, thus expanding access.

2. Patent Expiry and Generic Competition

Post-patent expiry, multiple pharmaceutical companies have introduced generic equivalents, intensifying price competition and reducing revenue for the originator. For instance, the expiration of the U.S. patent in 2017 resulted in several generics entering the market, decreasing average selling price by approximately 40-50% over subsequent years (FDA Orange Book records).

This proliferation of generics often accelerates market penetration, but can also reduce profit margins for original developers. The strategic response has involved lifecycle management tactics, such as developing extended-release formulations or new combination therapies to sustain revenue streams.

3. Market Penetration and Prescribing Trends

Despite generic availability, darifenacin maintains a niche owing to its receptor selectivity. Prescribers often consider patient-specific factors, including tolerability and comorbid conditions, influencing market share. The drug remains a preferred option where side effect profiles are a major concern, particularly in elderly populations with polypharmacy.

According to IQVIA data, the total global OAB pharmaceutical market was valued at approximately USD 4.2 billion in 2022, with the M3-targeted drugs representing around 25% of this segment. Darifenacin's market share post-generic entry is estimated to hover around 10-12% in the U.S. and European markets.

4. Competitive Landscape

The OAB therapeutic market features several key players: oxybutynin, tolterodine, solifenacin, darifenacin, fesoterodine, and trospium. While oxybutynin and tolterodine dominate due to long-standing market presence and lower costs, darifenacin's distinct selectivity offers a competitive edge in specific patient subsets. New entrants focus on novel mechanisms, such as β3-adrenoceptor agonists (e.g., mirabegron), which have captured additional market share, challenging traditional antimuscarinic drugs.

5. Market Drivers and Restraints

Drivers:

• Rising prevalence of OAB, fueled by aging populations worldwide.
• Increased awareness of treatment options among healthcare providers and patients.
• Availability of innovative formulations enhancing compliance.

Restraints:

• Side effects associated with antimuscarinics.
• Cost competition post-generic entry.
• Regulatory pressures on marketing and label updates.

Financial Trajectory and Projections

1. Revenue Trends

Post-launch, darifenacin generated annual sales exceeding USD 300 million globally. Following patent expirations, revenues declined sharply—by over 50% within three years—due to generic competition and price reductions. Nonetheless, niche positioning and formulary placements contribute to residual revenues.

2. Impact of Generic Entry

Generic proliferation has compressed profit margins for originators. According to industry analyses, the average price for darifenacin decreased by about 45% over five years after patent expiration, curbing revenue growth potential from new sales but enabling market expansion in lower-income regions due to affordability.

3. Strategic Opportunities for Sustained Revenue

Pharmaceutical companies are exploring lifecycle strategies such as developing fixed-dose combination therapies (e.g., darifenacin with β3-agonists), patenting new delivery systems (transdermal patches), and expanding therapeutic indications, including neurogenic bladder.

Furthermore, digital health integration—such as remote monitoring programs—may improve adherence and optimize treatments, potentially fostering incremental revenue streams.

4. Future Financial Outlook

Market analysts project a moderate recovery trajectory over the next five years, predicated on demographic shifts and healthcare policy reforms. The global OAB market is expected to reach USD 6 billion by 2027, with darifenacin's niche applications likely generating USD 150-200 million annually, assuming strategic adaptations.

The entry of biosimilars in related therapeutic segments and evolving treatment algorithms could further influence demand. Revenue stabilization hinges on innovation and differentiation within a highly competitive environment.

Regulatory and Market Challenges

Ongoing regulatory scrutiny, including re-evaluation of safety profiles and health authority mandates for label updates regarding cognitive risks, may influence prescribing rates. Additionally, the rising prominence of non-antimuscarinic therapies introduces competitive pressure, necessitating strategic positioning.

Key Market Opportunities

• Expansion into Emerging Markets: Price-sensitive regions represent growth opportunities where generic formulations dominate but technological enhancements can create premium segments.
• Product Innovation: Development of novel delivery metrics or combination therapies to extend patent exclusivity.
• Digital Health Integration: Employing telemedicine and adherence monitoring to increase patient engagement and treatment efficacy.

Conclusion

The financial trajectory of darifenacin hydrobromide stands at a pivotal juncture, shaped by patent expirations, market competition, and evolving therapeutic landscapes. While generic entry has compressed margins, strategic innovations and market expansion can sustain its relevance. Industry stakeholders must navigate the complex interplay of regulatory pressures, demographic trends, and technological advancements to optimize long-term financial outcomes.

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Key Takeaways

• Patent protection provided initial revenue streams, but generic entry drastically reduced profitability post-expiry.
• Niche advantages such as pharmacological selectivity afford darifenacin opportunities amid generic competition.
• Market growth is mainly driven by aging populations, with significant potential in emerging markets.
• Innovation strategies like combination therapies and delivery system improvements are vital for future revenue sustainability.
• Regulatory developments and alternative treatments like β3-agonists will influence market share dynamics in the coming years.

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FAQs

1. How has patent expiration affected darifenacin’s market share?
Patent expiry led to multiple generics entering the market, significantly reducing prices and margins. While overall sales volume increased, the original brand’s market share declined, stabilizing around 10-12% in key markets.

2. What competitive advantages does darifenacin hold over other OAB medications?
Its high selectivity for M3 receptors minimizes side effects such as dry mouth, improving tolerability in particular patient groups, especially the elderly.

3. Are there emerging therapies that threaten darifenacin’s market position?
Yes. β3-adrenoceptor agonists like mirabegron offer a different mechanism with fewer anticholinergic side effects, capturing increasing market share and challenging traditional antimuscarinics like darifenacin.

4. What strategies can prolong darifenacin's market relevance post-generics?
Developing combination therapies, new formulations, digital adherence tools, and expanding into new indications or markets can help sustain revenues.

5. What is the outlook for darifenacin in the next five years?
While revenues are expected to decline in mature markets, expansion into emerging markets, combined with innovation strategies, could stabilize or modestly grow its financial footprint.

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Sources:

[1] FDA Orange Book. Patent and exclusivity data.
[2] IQVIA. Market segmentation reports, 2022.
[3] Industry analysis reports on OAB therapeutics, 2023.
[4] World Health Organization. Overactive Bladder prevalence data, 2022.