ENABLEX Drug Patent Profile

When do Enablex patents expire, and when can generic versions of Enablex launch?

Enablex is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Enablex

A generic version of ENABLEX was approved as darifenacin hydrobromide by CIPLA on September 1^st, 2016.

Summary for ENABLEX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	16
Drug Prices:	Drug price information for ENABLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENABLEX
What excipients (inactive ingredients) are in ENABLEX?	ENABLEX excipients list
DailyMed Link:	ENABLEX at DailyMed

See drug prices for ENABLEX

Recent Clinical Trials for ENABLEX

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

Sponsor	Phase
Astellas Scientific & Medical Affairs, Inc.
Recalcine (GynoPharm)	Phase 3
Universidad de Valparaiso	Phase 3

See all ENABLEX clinical trials

Paragraph IV (Patent) Challenges for ENABLEX

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 ENABLEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004		DISCN	Yes	No
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004		DISCN	Yes	No

Expired US Patents for ENABLEX

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 ENABLEX

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

International Patents for ENABLEX

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	91163
Spain	2224002
Colombia	4750822	FORMULACIONES FARMACEUTICAS TADA PARA LA ADMINISTRACION EN EL TRACTO GASTROINTESTINAL Y PROCESOS PARA ELABORAR LAS MISMAS
Australia	703866

Supplementary Protection Certificates for ENABLEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0388054	C300191	Netherlands		PRODUCT NAME: DARIFENACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROBROMIDE; REGISTRATION NO/DATE: EU1/04/294/001 - 012, 20041022
0850059	SPC012/2005	Ireland		SPC012/2005, 20060725, EXPIRES: 20191021
0388054	21/2005	Austria		PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - EU/1/04/294/012 20041022
0850059	C00850059/01	Switzerland		FORMER OWNER: NOVARTIS AG, CH

ENABLEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ENABLEX

Overview of ENABLEX

ENABLEX, also known as darifenacin, is a medication used to treat overactive bladder (OAB) symptoms. It belongs to the class of anticholinergic drugs, which work by relaxing the bladder muscle to increase bladder capacity and reduce the need for frequent urination.

Market Size and Growth

The global overactive bladder treatment market, within which ENABLEX operates, is experiencing significant growth. Here are some key statistics:

• The global overactive bladder treatment market was valued at $3.5 billion in 2022 and is projected to reach $4.2 billion by 2027, growing at a CAGR of 3.6% from 2022 to 2027[1].
• Another report estimates the global OAB therapeutics market to be $1.2 billion in 2023, projected to reach $1.5 billion by 2030, with a CAGR of 2.8% from 2023 to 2030[3].

Segment Analysis

Anticholinergics Market

ENABLEX falls under the anticholinergics segment, which is a significant part of the OAB treatment market.

• The anticholinergics segment, including drugs like solifenacin, oxybutynin, tolterodine, and darifenacin, is expected to continue its growth trajectory. For instance, the anticholinergics therapy segment is projected to reach $614.7 million by 2030, growing at a CAGR of 3.1%[3].

Regional Performance

The market performance of ENABLEX and other OAB treatments varies by region:

• North America: This region, particularly the U.S., is a major market for OAB treatments. The U.S. market was estimated at $332.3 million in 2023 and is expected to grow steadily[3].
• Europe: Countries like Germany, France, Italy, Spain, and the UK also contribute significantly to the market. The EU-4 (Italy, Spain, France, and Germany) and the UK are key regions for OAB treatment sales[4].
• Asia-Pacific: Countries such as China, Japan, and India are seeing increased adoption of OAB treatments. China, for example, is forecasted to grow at an impressive 4.8% CAGR to reach $290.7 million by 2030[3].

Market Drivers

Several factors are driving the growth of the OAB treatment market, including ENABLEX:

• Aging Population: The global aging population is more susceptible to OAB, expanding the addressable market[3].
• Technological Advancements: Innovations in drug formulation and delivery systems, such as extended-release tablets, are making treatments more effective and user-friendly[3].
• Increased Awareness and Diagnosis: Educational campaigns and improved diagnostic tools are leading to higher treatment adoption rates[3].
• Lifestyle Diseases: The rising prevalence of lifestyle diseases like diabetes and obesity, which are risk factors for OAB, is contributing to market growth[3].

Market Challenges

Despite the growth, there are challenges that could impact the market trajectory of ENABLEX and other OAB treatments:

• Social Stigma: Social stigma and lack of awareness about OAB can restrict market growth[1].
• Product Recalls: Product recalls can negatively impact market confidence and sales[1].
• Side Effects: Anticholinergics, including ENABLEX, can have side effects, which may lead some patients to seek alternative treatments. However, ENABLEX is known for having fewer side effects compared to some other anticholinergics[5].

Competitive Landscape

The OAB treatment market is competitive, with various drugs and treatment options available:

• Mirabegron: This drug, known for having fewer side effects compared to anticholinergics, is also gaining traction in the market[1].
• BOTOX: BOTOX injections are another treatment option that is gaining popularity, especially in regions like China[1].
• Neuromodulation: Non-pharmacological interventions like neuromodulation are also becoming more popular, offering alternative treatment options for patients[3].

Financial Trajectory

Given the overall market trends and growth drivers, the financial trajectory for ENABLEX is likely to be positive:

• As part of the anticholinergics segment, ENABLEX will benefit from the segment's projected growth to $614.7 million by 2030[3].
• The increasing prevalence of OAB, technological advancements, and favorable reimbursement policies will continue to drive demand for ENABLEX and other OAB treatments[3].

Key Takeaways

• Market Growth: The global OAB treatment market, including ENABLEX, is expected to grow significantly due to an aging population, technological advancements, and increased awareness.
• Segment Performance: The anticholinergics segment, which includes ENABLEX, is projected to grow at a CAGR of 3.1% to reach $614.7 million by 2030.
• Regional Opportunities: Key regions such as North America, Europe, and the Asia-Pacific will continue to drive market growth.
• Challenges: Social stigma, product recalls, and side effects are challenges that need to be addressed.

FAQs

1. What is ENABLEX used for? ENABLEX, or darifenacin, is used to treat symptoms of overactive bladder, including frequent urination and urgency.

2. What class of drugs does ENABLEX belong to? ENABLEX belongs to the class of anticholinergic drugs.

3. What are the key drivers of the OAB treatment market? Key drivers include an aging population, technological advancements in drug formulation, increased awareness and diagnosis rates, and the rising prevalence of lifestyle diseases.

4. How is the anticholinergics segment expected to grow? The anticholinergics segment is projected to grow at a CAGR of 3.1% to reach $614.7 million by 2030.

5. What are some challenges facing the OAB treatment market? Challenges include social stigma, product recalls, and potential side effects associated with anticholinergic drugs.

Sources

1. MarketsandMarkets: Overactive Bladder Treatment Market Size And Global Industry ...
2. FDA: ENABLEX - accessdata.fda.gov
3. GlobeNewswire: $1.5 Billion Overactive Bladder (OAB) Therapeutics Markets
4. GlobeNewswire: Overactive Bladder Market to Grow Rapidly at a Considerable CAGR During the Forecast Period (2023–2032) | DelveInsight
5. Health Canada: Details for: ENABLEX - Drug and Health Product Register