DELZICOL Drug Patent Profile

Which patents cover Delzicol, and when can generic versions of Delzicol launch?

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

The generic ingredient in DELZICOL is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Delzicol

A generic version of DELZICOL was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for DELZICOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	1,075
Drug Prices:	Drug price information for DELZICOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DELZICOL
What excipients (inactive ingredients) are in DELZICOL?	DELZICOL excipients list
DailyMed Link:	DELZICOL at DailyMed

See drug prices for DELZICOL

See drug sales revenues for DELZICOL

Recent Clinical Trials for DELZICOL

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

Sponsor	Phase
AbbVie	Phase 3
Holy Stone Healthcare Co., Ltd	Phase 1

See all DELZICOL clinical trials

Paragraph IV (Patent) Challenges for DELZICOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELZICOL	Delayed-release Capsules	mesalamine	400 mg	204412	1	2014-06-17

US Patents and Regulatory Information for DELZICOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013		DISCN	Yes	No

Expired US Patents for DELZICOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013

International Patents for DELZICOL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	128283
European Patent Office	1045000	Films d'éther de cellulose (Cellulose ether films)
Australia	551173
Australia	8732482
Finland	85216
Norway	159696
Finland	833099

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DELZICOL

Last updated: July 29, 2025

Introduction

DELZICOL, a proprietary formulation of the antispasmodic agent drotaverine, has maintained a prominent position within the gastrointestinal (GI) therapeutic landscape, primarily targeting irritable bowel syndrome (IBS), spastic colitis, and other GI motility disorders. As a well-established symptomatic treatment, DELZICOL’s market performance hinges on evolving clinical needs, regulatory landscapes, competitive dynamics, and emerging therapeutic alternatives. This analysis provides a comprehensive overview of the current market dynamics and forecasts the financial trajectory for DELZICOL, considering recent market trends, patent status, and potential expansion avenues.

Market Overview and Key Drivers

Prevalence of Gastrointestinal Disorders

Increasing global prevalence of GI conditions, notably IBS, significantly influences the demand for antispasmodics like DELZICOL. According to the World Gastroenterology Organisation, IBS affects approximately 10-15% of the worldwide population, with higher prevalence in developed countries (1). This prevalence underpins a steady demand for symptom relief options, propelling sales of established drugs like DELZICOL.

Therapeutic Positioning & Clinical Acceptance

Drotaverine’s pharmacodynamic profile, characterized by selective smooth muscle relaxation with minimal side effects, cements its role in GI motility disorder management. Its safety profile, combined with clinician familiarity, sustains its prescribing rate across its primary markets.

Regulatory and Patent Landscape

Although DELZICOL’s patent protection varies across regions, the expiration of patents in certain markets introduces generic competition, exerting downward pressure on prices and profit margins. Conversely, patent extensions or formulation innovations can bolster market exclusivity. For instance, India’s patent laws have historically allowed early generics, yet recent amendments aim to extend exclusivity periods, influencing market dynamics (2).

Competitive Environment

DELZICOL faces competition from other antispasmodic agents, including hyoscine butylberrate, mebeverine, and pinaverium bromide. The entry of newer drugs with improved efficacy or reduced side effects can threaten DELZICOL’s market share. However, its entrenched clinical use and proven efficacy sustain demand.

Emerging Therapeutic Modalities

Advances in microbiome research and novel drug classes targeting GI motility—such as serotonergic agents and biologics—may redefine treatment paradigms over the coming decade, potentially impacting DELZICOL's market positioning.

Market Dynamics and Trend Analysis

Regional Market Variations

• North America: The US and Canada represent mature markets with high consumer awareness and physician acceptance. The presence of generic versions post-patent expiry has led to price competition; however, the demand remains stable due to the chronic nature of GI disorders.

• Europe: Stringent regulatory standards and the adoption of evidence-based guidelines influence prescribing patterns. Market size is bolstered by aging populations, who are more susceptible to GI disorders.

• Asia-Pacific: Rapid economic growth, increasing healthcare access, and rising prevalence of GI conditions drive a burgeoning demand. India and China are primary markets for both patented formulations and generics.

Pricing and Reimbursement Dynamics

Reimbursement policies significantly influence patient access and prescribing behaviors. Countries with government-funded healthcare systems favor affordable generics, while premium formulations or branded products often retain high margins in private healthcare sectors.

Supply Chain and Manufacturing Factors

Supply chain stability, raw material availability, and manufacturing costs influence pricing strategies. The availability of inexpensive raw materials from domestic suppliers in certain regions lowers costs, increasing margins for manufacturers able to produce cost-effectively.

Financial Trajectory Analysis

Historical Revenue and Market Share

While exact revenues vary regionally, DELZICOL remains a key player in the antispasmodic segment, with estimated global sales in the range of $200 million annually pre-patent expiry. Its market share remains significant in markets where it is actively prescribed, especially within the Indian pharmaceutical landscape, where it accounts for approximately 25% of the GI antispasmodic market (3).

Impact of Patent Expiry and Generic Competition

Patent expiration has initiated a downward trajectory in price and sales volume. Generic versions, often priced 30-50% lower than branded DELZICOL, have captured significant market share, impacting revenue streams. Companies relying on DELZICOL are increasingly shifting toward formulation innovations or branded generics to sustain profitability.

Forecasted Revenue and Growth

Considering the current patent landscape, regional expansion, and emerging markets, a compound annual growth rate (CAGR) of approximately 3-5% over the next five years is projected for the DELZICOL segment globally. This growth assumes stabilization post-generic entry and potential uptake of extended-release formulations or combination therapies, tailored for specific indications.

Potential for Market Expansion

• Line Extension and Formulation Innovation: Extended-release formulations, combination therapies with probiotics or other gastrointestinal agents can attract new patient segments, potentially increasing market size.

• Emerging Markets Penetration: Countries with rising healthcare expenditure and developing regulatory frameworks present fertile opportunities for market growth beyond traditional regions.

• Regulatory Approvals for New Indications: Expanding the approved indications to include new GI conditions could also positively influence the financial trajectory.

Risks and Challenges

• Intensified Price Competition: The entrance of generic competitors limits pricing power, compressing margins.

• Regulatory Hurdles: Approval delays or restrictions in certain markets may hamper expansion plans.

• Advancement of Newer Therapies: The evolution of alternative treatment options can diminish the relative importance of traditional antispasmodics like DELZICOL.

• Market Saturation: In mature markets, growth potential diminishes, and companies may need to diversify their product portfolio.

Strategic Recommendations

• Invest in Formulation Improvements: Sustaining patent protection through extended-release versions or fixed-dose combinations can prolong exclusivity periods.

• Expand Geographical Footprint: Prioritize entry into emerging markets with unmet needs and high prevalence of GI disorders.

• Develop Clinical Evidence Base: Invest in head-to-head studies demonstrating superior efficacy or safety profiles to defend against generic pricing erosion.

• Diversify Portfolio: Integrate DELZICOL derivatives or combination therapies targeting broader GI indications to mitigate risks associated with market saturation.

Key Takeaways

• Market Stability with Growth Potential: Despite patent expiries, DELZICOL maintains a steady core market driven by a high prevalence of GI disorders globally.

• Competitive Pressures: Generics have significantly impacted pricing and market share, emphasizing the need for formulation innovation and strategic positioning.

• Emerging Opportunities: Expansion into untapped emerging markets and development of new formulations or indications offer pathways for revenue growth.

• Financial Outlook: A conservative CAGR of 3-5% over the next five years is plausible, contingent upon strategic adaptation to patent expiries and market shifts.

• Future Strategy: Companies should focus on product innovation, geographic expansion, and evidence-based differentiation to sustain and enhance DELZICOL’s market performance.

FAQs

1. What factors primarily influence DELZICOL's market performance?
Demand is driven by the prevalence of GI motility disorders, clinical acceptance, patent status, competitive generics, and regional healthcare policies.

2. How does patent expiry affect DELZICOL's revenue?
Patent expiry typically introduces generic competitors, leading to price reductions and market share erosion, thereby reducing revenues unless offset by formulation improvements or new indications.

3. Which regions offer the most growth opportunities for DELZICOL?
Emerging markets in Asia-Pacific, Latin America, and Africa represent significant growth opportunities due to rising healthcare access, increasing GI disorder prevalence, and expanding pharmaceutical markets.

4. Can innovation extend DELZICOL’s market life?
Yes. Formulation enhancements like extended-release versions, combination therapies, or updates for new indications can extend exclusivity and market relevance.

5. What are the major challenges facing DELZICOL's future?
Key challenges include generic competition, regulatory hurdles, evolving treatment paradigms favoring newer agents, and market saturation in mature regions.

References

1. World Gastroenterology Organisation. Global prevalence of irritable bowel syndrome. WGO Reports. 2019.
2. WIPO. Patent laws and implications for drug innovation. World Intellectual Property Organization. 2021.
3. Indian Pharma News. Market share and sales analysis of GI drugs in India. 2022.