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:	66
Clinical Trials:	16
Patent Applications:	221
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.
Universidad de Valparaiso	Phase 3
Recalcine (GynoPharm)	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
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 ENABLEX

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

International Patents for ENABLEX

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

Country	Patent Number	Title	Estimated Expiration
Austria	233090
Yugoslavia	52790
Portugal	1245231
Poland	185604
German Democratic Republic	292911	VERFAHREN ZUR HERSTELLUNG VON PYRROLIDINDERIVATEN
Slovakia	129590	3-SUBSTITUTED PYROLIDINE DERIVATIVE, PREPARATION METHOD THEREOF, INTERMEDIATE PRODUCTS OF THIS METHOD, PHARMACEUTICAL COMPOSITION CONTAINING THIS DERIVATIVE

Supplementary Protection Certificates for ENABLEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0388054	C00388054/01	Switzerland		FORMER OWNER: NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., BM
0388054	91161	Luxembourg		91161, EXPIRES: 20150302
0850059	CA 2005 00020	Denmark
0388054	05C0017	France		PRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022
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

Market Dynamics and Financial Trajectory for ENABLEX

Last updated: July 30, 2025

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Introduction

ENABLEX (Dicyclomine Hydrochloride) is a therapeutically significant drug primarily used for the treatment of irritable bowel syndrome (IBS) and other gastrointestinal disorders. As a member of the anticholinergic class, ENABLEX offers symptomatic relief by reducing bowel spasms, positioning it within a competitive and evolving gastroenterological pharmaceutical market. This analysis explores current market dynamics, competitive landscape, regulatory influences, and projected financial trajectories shaping ENABLEX’s future.

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Market Landscape and Growth Drivers

Global Gastrointestinal Drugs Market

The global gastrointestinal (GI) drugs market is projected to reach USD 48.6 billion by 2027, expanding at a compound annual growth rate (CAGR) of approximately 4.4% (2022–2027) [1]. The growth stemmed from the rising prevalence of GI disorders—particularly IBS, characterized by altered bowel habits and abdominal discomfort—coupled with increasing awareness and improved diagnostic capabilities.

ENABLEX primarily addresses IBS and related syndromes, positioning it well within this expanding market. The increased acceptance of targeted GI therapies among healthcare providers and patients further drives demand.

IBS Incidence and Demographics

IBS affects an estimated 10-15% of the global population, with higher prevalence among women, individuals aged 25–45, and certain ethnic groups [2]. The rising prevalence is linked to lifestyle factors—stress, diet, sedentary habits—that are intensifying globally. This demographic trend fuels a sustained need for effective, tolerable treatment options like ENABLEX.

Key Market Drivers

• Increased Awareness and Diagnosis: Enhanced understanding of IBS and availability of specialized GI tests underpin higher diagnosis rates.
• Expanding Patient Base: Growing demographics affected by IBS worldwide.
• Product Efficacy and Safety Profile: ENABLEX’s tolerability and efficacy support its continued usage.
• Healthcare Spending Growth: Rising healthcare expenditure influences prescription trends positively.

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Competitive and Regulatory Environment

Market Competition

ENABLEX faces competition from a spectrum of GI drugs, including antispasmodics, antidepressants, probiotics, and emerging biologics. Notable competitors include:

• Hyoscine Butylberrate (Buscopan): Widely used antispasmodic with similar indications.
• Peppermint Oil: Over-the-counter alternative gaining popularity.
• Rifaximin: Antibiotic used for certain IBS subtypes.
• Eluxadoline: Mu-opioid receptor modulator approved for IBS with diarrhea [3].

The competitive landscape underscores the importance of ENABLEX’s positioning based on its unique efficacy profile, side-effect management, and patient adherence.

Regulatory Considerations

The regulatory pathway for ENABLEX varies regionally. While approved for GI spasm relief, some jurisdictions have tightened restrictions related to anticholinergic agents due to concerns over cognitive side effects in the elderly. Regulatory agencies such as the FDA and EMA periodically review safety profiles, influencing marketing strategies and dosing guidelines.

The recent trend favoring minimally invasive or non-systemic therapies may impact future formulations and indications of ENABLEX, prompting innovation and potential new label claims.

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Market Challenges

• Side Effect Profile: Anticholinergic drugs like ENABLEX carry risks of dry mouth, dizziness, and cognitive effects, especially with long-term use.
• Generic Competition: Availability of cheaper generics significantly compresses margins, compelling manufacturers to differentiate through formulation improvements or combination therapies.
• Off-Label Use and Over-the-Counter (OTC) Sales: The ease of OTC access to some antispasmodics might limit prescriptions, affecting revenue.
• Emergence of Novel Therapies: Biologic agents, neuromodulators, and microbiome-targeted therapies threaten the traditional market share of drugs like ENABLEX.

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Financial Trajectory and Revenue Outlook

Historical Performance and Current Status

While specific revenue figures for ENABLEX are proprietary, its manufacturer’s filings indicate steady sales in markets where it is approved. The drug benefits from a committed patient base and physician preference for its efficacy.

Forecasting Future Revenue

Factors influencing ENABLEX’s financial trajectory include:

• Market Penetration: Expanding into emerging markets via strategic licensing and partnerships.
• Indication Expansion: Potential approval for adjunctive or alternative indications such as functional dyspepsia.
• Line Extension and Formulation Innovation: Development of sustained-release or combination formulations to improve adherence and minimize side effects.
• Dose Optimization: Reducing side-effect profiles through optimized dosing could enhance tolerability, broadening patient eligibility.

Based on industry trends and company guidance, it is plausible that ENABLEX’s revenue could grow modestly at a CAGR of 3–5% over the next five years, driven by geographic expansion and product innovation. However, aggressive patent expirations or regulatory hurdles could temper this trajectory.

Impact of Generic Entry and Patent Expirations

Patent expirations in key markets are imminent or already occurred, exposing ENABLEX to pricing pressures. Generic entry typically results in revenue erosion of approximately 80% within a few years post-patent expiry, emphasizing the importance of differentiation strategies.

Strategic Initiatives and Market Expansion

To sustain growth, companies might:

• Pursue regulatory approval in additional indications.
• Develop combo formulations with other GI agents.
• Expand access to OTC formulations in select markets.
• Invest in biome-targeted therapies that complement or replace traditional antispasmodics.

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Regulatory and Commercial Risk Factors

• Regulatory tightening regarding anticholinergics' cognitive side-effects may restrict market access.
• Pricing pressures driven by generic competition.
• Market saturation in mature regions (North America, Europe).
• Unmet needs in specific populations (elderly, pediatric) require careful clinical evaluation.
• Innovation pipeline stagnation could limit long-term growth prospects.

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Key Takeaways

• ENABLEX operates within a significant and growing segment of the GI therapeutics market, driven by increasing IBS prevalence.
• Market expansion hinges on geographic penetration, indication expansion, and formulation innovation.
• Revenue growth prospects are challenged by generic competition, regulatory scrutiny, and side-effect profiles.
• Strategic differentiation through formulations and target populations will be critical to long-term financial sustainability.
• Monitoring regulatory policies and competitor developments is vital for predicting ENABLEX's market trajectory.

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FAQs

1. What are the main factors influencing ENABLEX’s market growth?
Market growth depends on rising IBS prevalence, geographic expansion, product differentiation, and regulatory environment adaptations.

2. How does ENABLEX compare to its competitors?
ENABLEX’s efficacy and tolerability profile position it favorably, but competition from OTC options and newer biologics requires ongoing innovation.

3. What challenges does ENABLEX face due to patent expiration?
Patent expiration opens the market to generics, significantly reducing revenues unless offset by indication expansion or formulation innovation.

4. Are there regulatory risks threatening ENABLEX’s market presence?
Yes, concerns over anticholinergic side effects, especially cognitive effects in elderly patients, might lead to restrictions or label changes.

5. What strategic moves can sustain ENABLEX’s market share?
Investing in new formulations, expanding indications, entering emerging markets, and developing combination therapies are key strategies.

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References

[1] MarketWatch. (2022). Global Gastrointestinal Drugs Market Size, Share & Trends Analysis.
[2] Ford, A.C., et al. (2017). Epidemiology of IBS: A Systematic Review. American Journal of Gastroenterology.
[3] US Food and Drug Administration. (2016). FDA Approves Eluxadoline for IBS with Diarrhea.