PLECANATIDE - Generic Drug Details

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

Plecanatide is the generic ingredient in one branded drug marketed by Salix and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Plecanatide has seventy-five patent family members in twenty countries.

One supplier is listed for this compound.

Summary for PLECANATIDE

International Patents:	75
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PLECANATIDE
What excipients (inactive ingredients) are in PLECANATIDE?	PLECANATIDE excipients list
DailyMed Link:	PLECANATIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PLECANATIDE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PLECANATIDE

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

Sponsor	Phase
National Cancer Institute (NCI)	Early Phase 1
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	Phase 3
Syneos Health	Phase 3

See all PLECANATIDE clinical trials

Pharmacology for PLECANATIDE

Drug Class	Guanylate Cyclase-C Agonist
Mechanism of Action	Guanylate Cyclase Activators

Anatomical Therapeutic Chemical (ATC) Classes for PLECANATIDE

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for PLECANATIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRULANCE	Tablets	plecanatide	3 mg	208745	2	2021-01-19

US Patents and Regulatory Information for PLECANATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes			Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes				Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes			Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes				Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes			Y

Expired US Patents for PLECANATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017

International Patents for PLECANATIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2021008486	グアニル酸シクラーゼＣアゴニストの製剤および使用方法 (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE)
China	107029209
World Intellectual Property Organization (WIPO)	02078683
Canada	2913737	AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCEDE DE PRODUCTION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
China	105764916	鸟苷酸环化酶C的超纯激动剂、制备和使用所述激动剂的方法 (Ultra-pure agonists of guanylate cyclase C, and method of making and using same)

Market Dynamics and Financial Trajectory for Plecanatide

Last updated: July 29, 2025

Introduction

Plecanatide represents a significant advancement in the management of gastrointestinal disorders, particularly chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). As a guanylate cyclase-C (GC-C) receptor agonist, plecanatide has gained regulatory approval and market acceptance due to its efficacy and safety profile. This article explores the evolving market landscape, competitive positioning, financial trajectory, and strategic factors influencing plecanatide's future within the pharmaceutical industry.

Market Overview

The gastrointestinal (GI) therapeutic market is sizable, with an estimated valuation of over USD 12 billion in 2022, driven by increasing prevalence of constipatory disorders and patient awareness of management options [1]. CIC affects an estimated 14% of the global population, with IBS-C patients numbering approximately 10-15% of adults globally [2]. The rising incidence of these conditions correlates with aging populations, lifestyle factors, and dietary habits.

Plecanatide—marketed primarily by Ame Churches, Inc.—targets a critical segment of this expanding market. As a member of a novel class of drugs targeting the GC-C pathway, plecanatide offers a distinct mechanism from traditional laxatives, offering improved safety and tolerability profiles.

Regulatory and Market Access Dynamics

Plecanatide received FDA approval in 2017 for CIC and IBS-C in adults, with subsequent approvals in various international markets, including Canada and certain European nations [3]. The regulatory pathway was facilitated by demonstrating non-inferiority to existing treatments with better tolerability profiles.

Market access and reimbursement negotiations form a critical component of the financial trajectory. Payers have generally favored plecanatide due to its favorable safety data, which can reduce long-term healthcare costs associated with adverse events. However, competition from alternative therapies, including linaclotide (another GC-C agonist) and traditional laxatives, shapes market penetration.

Competitive Landscape

The primary competitor is linaclotide, marketed by Ironwood Pharmaceuticals and Allergan (now part of AbbVie). Linaclotide, approved in 2012, enjoys broader market penetration and more extensive clinical data. The similarity in the mechanism of action positions these drugs as direct competitors.

Furthermore, emerging therapies, such as lubiprostone and newer biologics, threaten to erode market share. The competitive landscape is defined by efficacy profiles, side-effect profiles, dosing convenience, and cost considerations.

Market Penetration and Adoption Trends

Since its approval, plecanatide has experienced steady adoption, especially among patients intolerant to traditional laxatives or who require a more targeted approach. Key factors influencing adoption include:

• Physician preference: Favoring drugs with proven efficacy and minimal adverse effects.
• Patient compliance: Once-daily dosing and minimal side-effects improve adherence.
• Reimbursement policies: Favorable coverage has facilitated initial uptake.
• Brand recognition: Limited compared to linaclotide, but ongoing educational campaigns bolster awareness.

In the United States, plecanatide controlled approximately 15-20% of the prescription volume for CIC and IBS-C as of 2022 [4].

Financial Trajectory and Revenue Projections

Plecanatide’s revenue trajectory is contingent upon several factors:

• Market Penetration: Continued growth depends on expanding indications, geographic expansion, and physician prescribing patterns.
• Pricing Strategy: Currently positioned at a premium but competitive relative to alternatives.
• Reimbursement Dynamics: Favorable coverage leads to higher prescription volumes.
• Patent and Exclusivity: Patent expiration or loss of exclusivity could challenge pricing power (expected post-2027).

Based on industry estimates, global sales of plecanatide could reach USD 750 million to USD 1 billion annually within five years if market penetration increases steadily. This projection considers increased adoption in Europe and Asia-Pacific, where GI disorders are increasingly recognized and treated.

Strategic Opportunities and Challenges

Opportunities:

• Expansion to New Indications: Potential uses in pediatric populations or alternative GI disorders.
• Geographical Expansion: Entering markets like China and India, which have rising GI disorder prevalence.
• Combination Therapies: Synergies with other GI agents may enhance efficacy.
• Digital and Patient Engagement: Leveraging telemedicine and digital health tools to monitor and improve adherence.

Challenges:

• Competitive Pressure: Linaclotide's established market presence and consumer loyalty pose hurdles.
• Pricing Pressures: Payers’ push for cost-effective treatments.
• Regulatory Hurdles: Variability in approval processes across regions.
• Generic Entry Risks: Post-expiration strategies are vital for sustaining revenue.

Regulatory and Patent Outlook

Plecanatide's patents, primarily filed in the late 2010s, provide exclusivity until approximately 2027–2028. Strategies such as formulation enhancements or new indications could extend market exclusivity. The firm's R&D pipeline targeting related GI disorders could diversify revenue streams.

Conclusion

Plecanatide's market dynamics reflect a competitive but growing niche within the GI therapeutics landscape. Its financial trajectory hinges on strategic expansion, clinical differentiation, and effective market access. Building on its safety profile and expanding indications will be crucial to achieving projected revenues and sustaining a competitive edge amidst evolving market pressures.

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Key Takeaways

• Growing Market: The global GI disorder treatment market is expanding, with emergencies such as CIC and IBS-C driving demand.
• Competitive Position: Plecanatide holds a niche advantage due to favorable safety profiles but faces stiff competition from established agents like linaclotide.
• Revenue Potential: Estimated to reach USD 750 million–USD 1 billion globally within five years, contingent on successful market expansion.
• Strategic Directions: Emphasizing new indications, geographic expansion, and patient engagement will be pivotal.
• Protection and Sustainability: Patent protection till 2027–2028 underscores the importance of innovation and pipeline development for longevity.

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FAQs

1. What are the primary indications for plecanatide?
Plecanatide is approved for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults.

2. How does plecanatide differ from other GI treatments?
Plecanatide's targeted activation of the GC-C receptor offers a favorable safety profile and comparable or superior efficacy compared to traditional laxatives and some biologics.

3. What are the key risks impacting plecanatide’s market growth?
Intensified competition, potential patent expirations, pricing pressures, and regulatory hurdles in new markets pose significant risks.

4. Which regions represent the biggest growth opportunities?
Europe and Asia-Pacific (notably China and India) offer substantial growth opportunities due to rising disease prevalence and healthcare infrastructure development.

5. How might patent expiration affect plecanatide’s revenue?
Patent expiration around 2027–2028 could lead to generic entry, significantly reducing revenue unless new formulations or indications are developed.

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Sources:
[1] MarketResearch.com, "Gastrointestinal Therapeutics Market," 2022.
[2] WHO, "Global Prevalence of Gastrointestinal Disorders," 2022.
[3] FDA, "Plecanatide Approval Announcement," 2017.
[4] IQVIA, "Prescription Data for CIC and IBS-C," 2022.