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, Endo Operations, Jubilant Generics, 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:	78
Clinical Trials:	1
Patent Applications:	33
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
Toronto Rehabilitation Institute	Phase 4
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
Torrent	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	205209-001	Nov 17, 2016	AB	RX	No	No
Polygen Pharms	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	211045-002	Jan 6, 2020	AB	RX	No	No
Alembic	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207681-002	Dec 8, 2017	AB	RX	No	No
Polygen Pharms	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	211045-001	Jan 6, 2020	AB	RX	No	No
Xiromed	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	209571-001	Oct 22, 2019		DISCN	No	No
Aurobindo Pharma	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	206743-001	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	021513-002	Dec 22, 2004	6,106,864
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004	5,096,890
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	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/000554 Symptomatic 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

DARIFENACIN HYDROBROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Darifenacin Hydrobromide

Introduction to Darifenacin Hydrobromide

Darifenacin hydrobromide is a selective antagonist for the M3 muscarinic acetylcholine receptor, primarily used in the treatment of overactive bladder with symptoms of urge urinary incontinence[2][4][5].

Market Size and Growth Projections

The global Darifenacin Hydrobromide market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market was valued at approximately US$ 440 million. It is anticipated to reach US$ 657.3 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.9% during the forecast period from 2024 to 2030[3][4].

Market Drivers

Several factors are driving the growth of the Darifenacin Hydrobromide market:

Increasing Prevalence of Overactive Bladder

The rising incidence of overactive bladder and associated urinary incontinence is a major driver. As the global population ages, the demand for effective treatments like darifenacin hydrobromide is expected to increase.

Advancements in Pharmaceutical Technology

Continuous advancements in pharmaceutical technology and drug formulation are enhancing the efficacy and safety of darifenacin hydrobromide, making it a preferred treatment option.

Expanding Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, are increasing access to medications like darifenacin hydrobromide, contributing to market growth.

Market Restraints

Despite the growth, there are several restraints to consider:

Side Effects and Safety Concerns

Darifenacin hydrobromide is associated with side effects such as dry mouth, constipation, and urinary retention, which can limit its adoption in certain patient groups[2].

Regulatory Hurdles

Stringent regulatory requirements and the need for rigorous clinical trials can slow down the approval and launch of new formulations or generic versions of darifenacin hydrobromide.

Market Segmentation

The Darifenacin Hydrobromide market is segmented in several ways:

By Type

The market is segmented into 7.5mg and 15mg formulations, each catering to different patient needs and severity of symptoms[4].

By Application

The primary applications are in hospitals, clinics, and other healthcare settings. The market is also seeing growth in outpatient treatments due to the convenience of extended-release formulations[4].

By Region

The market is geographically segmented into North America, Europe, Asia Pacific, South America, and the Middle East and Africa. The Asia Pacific region is expected to show significant growth due to its large population and improving healthcare infrastructure[3][4].

Competitive Landscape

The Darifenacin Hydrobromide market is competitive, with several key players:

• Polygen Pharms
• Xiromed
• Alembic Pharms
• Cipla
• Macleods Pharms
• Aurobindo Pharma
• Jubilant Generics
• Torrent Pharma
• Par Pharmaceutical
• Aristo Pharma
• Novartis
• Chiatai Atianqing
• Runzong Pharma
• Furui Kangzheng[4].

These companies are engaged in various strategies such as product innovation, mergers and acquisitions, and expansion into new markets to maintain their market share.

Regional Market Analysis

Asia Pacific

This region is expected to be a significant growth driver due to its large and aging population, along with improvements in healthcare infrastructure and increasing healthcare spending[3][4].

North America and Europe

These regions have a well-established market for darifenacin hydrobromide, with a high demand driven by the prevalence of overactive bladder and the availability of advanced healthcare services.

Latin America and Middle East and Africa

These regions are also showing growth, albeit at a slower pace, due to emerging healthcare markets and increasing awareness of available treatments.

Financial Performance and Forecasts

The financial performance of the Darifenacin Hydrobromide market is robust, with significant revenue growth anticipated:

• Revenue Forecast: The market is expected to grow from US$ 440 million in 2023 to US$ 657.3 million by 2030[3][4].
• Sales Volume: The sales volume is also expected to increase, driven by the growing demand for the drug across various regions[4].

Technological Trends and New Product Developments

The market is witnessing technological advancements in drug formulation and delivery systems. Extended-release tablets, for instance, have improved patient compliance and reduced the frequency of dosing, enhancing the overall treatment experience[2].

Impact of COVID-19

The COVID-19 pandemic has highlighted the importance of robust supply chain management and the agility of pharmaceutical companies in responding to public health needs. While the pandemic did not significantly impact the demand for darifenacin hydrobromide, it underscored the need for reliable and efficient drug supply chains[4].

Key Takeaways

• The Darifenacin Hydrobromide market is projected to grow significantly, driven by increasing demand and advancements in pharmaceutical technology.
• The market is segmented by type, application, and region, with the Asia Pacific region expected to be a major growth driver.
• Key players are focusing on product innovation and market expansion to maintain their competitive edge.
• Despite growth, the market faces restraints such as side effects and regulatory hurdles.

Frequently Asked Questions (FAQs)

What is Darifenacin Hydrobromide used for?

Darifenacin hydrobromide is used for the treatment of overactive bladder with symptoms of urge urinary incontinence[2].

What are the common side effects of Darifenacin Hydrobromide?

Common side effects include dry mouth, constipation, and urinary retention[2].

What is the projected market size of Darifenacin Hydrobromide by 2030?

The market is expected to reach US$ 657.3 million by 2030[3][4].

Which regions are expected to drive the growth of the Darifenacin Hydrobromide market?

The Asia Pacific region is expected to be a significant growth driver, along with North America and Europe[3][4].

Who are the key players in the Darifenacin Hydrobromide market?

Key players include Polygen Pharms, Xiromed, Alembic Pharms, Cipla, and others[4].

Sources:

1. Market Research Intellect: Global Darifenacin Hydrobromide Market Size, Trends and Projections.
2. DailyMed: Darifenacin hydrobromide tablet, extended release.
3. Market Research Reports: Global Darifenacin Hydrobromide Market Research Report 2023.
4. QY Research: Global Darifenacin Hydrobromide Market Research Report 2024.
5. PubChem: Darifenacin Hydrobromide | C28H31BrN2O2 | CID 444030.