DARIFENACIN HYDROBROMIDE - Generic Drug Details

What are the generic sources for darifenacin hydrobromide and what is the scope of freedom to operate?

Darifenacin hydrobromide is the generic ingredient in three branded drugs marketed by Macleods Pharms Ltd, Alembic, Aurobindo Pharma, Cipla, Jubilant Generics, Ph Health, Puracap Labs Blu, 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:	473
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
Oliver Blanchard	PHASE2
Université de Montréal	PHASE2
Ontario Neurotrauma Foundation	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
Puracap Labs Blu	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	211045-002	Jan 6, 2020	AB	RX	No	No
Jubilant Generics	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	205550-002	Oct 12, 2016		DISCN	No	No
Aurobindo Pharma	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	206743-002	Sep 19, 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	5,096,890
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004	6,106,864
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004	6,106,864

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: February 20, 2026

What is Darifenacin Hydrobromide?

Darifenacin hydrobromide is a selective antagonist of the M3 muscarinic receptor, primarily used for the treatment of overactive bladder (OAB). It was developed by Pfizer and approved by the U.S. FDA in 2007. The drug's mechanism involves reducing bladder muscle spasms by inhibiting parasympathetic signals, leading to increased bladder capacity and decreased urgency.

Market Size and Growth Drivers

The global overactive bladder treatment market was valued at approximately $3.2 billion in 2022. It is projected to reach $4.6 billion by 2030, with a compound annual growth rate (CAGR) of 4.7% from 2023 onwards (Grand View Research, 2022).

Darifenacin's market share has historically been below 10%, primarily due to competition from other antimuscarinics and newer agents such as beta-3 adrenergic receptor agonists. The drug's specific profile, including a favorable side effect profile compared to less selective agents, sustains its relevance.

Competitive Landscape

Key Drugs in the OAB Class

Drug Name	Market Entry Year	Key Features	Estimated Market Share (%) (2022)
Solifenacin (Vesicare)	2008	High selectivity for M3 receptors	15
Trospium (Sanctura)	2006	Quaternary amine, fewer CNS side effects	10
Oxybutynin (Ditropan)	1978	First-generation antimuscarinic, broad action	20
Mirabegron (Myrbetriq)	2012	Beta-3 receptor agonist, non-antimuscarinic	25
Darifenacin	2007	Selective for M3 receptors, once daily dose	8

Patent and Regulatory Status

Pfizer's patent for darifenacin expired in the U.S. in 2014, opening the market to generics. Several generic versions entered the market in 2015, leading to significant price erosion. In Europe and Asia, patent protection extended until 2016–2018 in some jurisdictions.

Off-Patent Competition and Biosimilars

Post-patent expiry, generic formulations have captured approximately 80% of the U.S. market for darifenacin, mainly due to price competition. No biosimilars exist, as the drug is small-molecule.

Pricing and Revenue Trends

Historical Pricing

Year	Average Wholesale Price (AWP) per 30 tablets	Notes
2010	$250	Brand-name only
2014	$180	Price decline before generics
2016	$90	Post-generic entry
2022	$60	Market consolidation

Revenue Trajectory

Pfizer's peak annual sales (2011–2013) approached $150 million. Current revenues from darifenacin are negligible post-generic competition, with market sales in the U.S. estimated at under $10 million annually.

Regulatory and R&D Pipeline

Pfizer's patent expiration led to the withdrawal of the original product from some markets. No recent regulatory filings or new formulations for darifenacin are reported, indicating limited R&D activity on this molecule. Industry focus has shifted toward combination therapies and agents targeting beta-3 receptors.

Future Market Outlook

The OAB market growth relies on aging populations and increased diagnosis. Entry of newer non-antimuscarinic agents limits demand for darifenacin. Clinical trials on combination therapies or novel delivery methods for existing drugs could impact the competitive landscape.

In markets where brand loyalty persists, especially among patients intolerant to other medications, darifenacin retains niche value. However, price sensitivity and generic availability suppress revenue potential significantly.

Key Takeaways

• Darifenacin hydrobromide's initial market was approximately $150 million annually in peak years.
• Patent expiration in 2014 led to immediate generic competition, eroding revenue sources.
• Current market sales are minimal, mainly driven by generics with low pricing.
• The broader OAB treatment market continues to grow, but darifenacin's share is limited due to competition from newer agents.
• No recent significant R&D efforts or formulations are announced, reflecting diminished strategic focus.

FAQs

1. Is darifenacin hydrobromide still available commercially?
Yes, generic versions are available, mainly in the U.S. and Europe, but the original branded version is less prominent.

2. How does darifenacin compare to beta-3 receptor agonists?
It targets muscarinic receptors selectively, whereas beta-3 agonists like mirabegron act via different pathways, often offering fewer anticholinergic side effects.

3. What factors influence darifenacin's marketability?
Patent expiry, competition from generics and newer agents, pricing, and physician prescribing habits.

4. Are there ongoing developments for darifenacin?
No significant new formulations or trials have been reported in recent years.

5. What is the outlook for darifenacin in emerging markets?
Market penetration depends on regulatory approvals and pricing policies; generic availability may facilitate some demand.

Sources:

[1] Grand View Research. (2022). Overactive Bladder Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2007). FDA Approval for Daranifenacin.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] European Medicines Agency. (2016). Summary of Product Characteristics.