TRULANCE Drug Patent Profile

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

Trulance is a drug marketed by Salix and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-five patent family members in twenty countries.

The generic ingredient in TRULANCE is plecanatide. One supplier is listed for this compound. Additional details are available on the plecanatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Trulance

Trulance was eligible for patent challenges on January 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 5, 2034. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRULANCE

International Patents:	75
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	5
Drug Prices:	Drug price information for TRULANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRULANCE
What excipients (inactive ingredients) are in TRULANCE?	TRULANCE excipients list
DailyMed Link:	TRULANCE at DailyMed

See drug prices for TRULANCE

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

Constraining patent/regulatory exclusivity:

10,011,637

NDA:

208745

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 TRULANCE

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

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 3
Synergy Pharmaceuticals Inc.	Phase 3
Bausch Health Americas, Inc.	Phase 2

See all TRULANCE clinical trials

Pharmacology for TRULANCE

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

Paragraph IV (Patent) Challenges for TRULANCE

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

US Patents and Regulatory Information for TRULANCE

TRULANCE is protected by twelve US patents.

This potential generic entry date is based on patent 10,011,637.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,919,024
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	9,925,231		Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	11,319,346		Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	9,616,097		Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	9,610,321

Expired US Patents for TRULANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017	7,799,897
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017	8,637,451

International Patents for TRULANCE

When does loss-of-exclusivity occur for TRULANCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRULANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2009001582	GUANYLATE CYCLASE RECEPTOR AGONIST FOR TREATMENT OF TISSUE INFLAMMATION AND CARCINOGENESIS
Hong Kong	1136585
World Intellectual Property Organization (WIPO)	2012037380
Eurasian Patent Organization	201592263	УЛЬТРАЧИСТЫЕ АГОНИСТЫ ГУАНИЛАТЦИКЛАЗЫ C, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ
European Patent Office	4424697	AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCÉDÉ DE FABRICATION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRULANCE

Last updated: July 27, 2025

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Introduction

TRULANCE (plecanatide) is a synthetic peptide selectively stimulating guanylate cyclase-C (GC-C) receptors in the gastrointestinal tract. Approved by the U.S. Food and Drug Administration (FDA) in 2017, it treats chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. Its unique mechanism and evolving market landscape position TRULANCE as a significant player in gastrointestinal therapeutics.

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Market Overview and Demand Drivers

Growing Prevalence of Gastrointestinal Disorders

The rising incidence of chronic constipation globally amplifies demand for targeted therapies like TRULANCE. According to the American College of Gastroenterology, approximately 14% of the U.S. population suffers from CIC, with similar trends globally, especially in aging demographics [1].

Limited Therapeutic Alternatives and Market Position

TRULANCE competes mainly with traditional laxatives, fiber supplements, and newer agents like linaclotide (Linzess), lubiprostone, and plecanatide (another GC-C agonist). Its advantages include a favorable safety profile, good tolerability, and convenience, attracting both patients and clinicians seeking alternatives to osmotic laxatives and fiber supplements.

Regulatory and Reimbursement Environment

Having FDA approval and inclusion in treatment guidelines enhances its market access. Reimbursement policies, contingent on health technology assessments, also influence prescription patterns, especially with managed healthcare providers prioritizing cost-effective therapies.

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Market Dynamics

Competitive Landscape

The gastrointestinal pharmacopeia has seen intensifying competition post-2017, with plecanatide and linaclotide leading the GC-C agonist segment. While linaclotide boasts a longer market history since 2012, TRULANCE’s recent introduction has constrained its market share growth but offers differentiation through its dosing regimens and side effect profiles.

Pricing Strategies and Market Penetration

Pricing remains a critical determinant—initial pricing for TRULANCE was aligned with linaclotide, approximately $500 per month. Market penetration strategies include direct-to-consumer advertising, physician education, and formulary inclusion. Though initial uptake was steady, the presence of competing generic and branded options has kept price pressures high.

Patient Compliance and Safety Profile

Adherence to therapy influences sales; TRULANCE’s low incidence of adverse effects like diarrhea and abdominal pain supports sustained use. Its once-daily oral dosage enhances convenience, a significant factor in patient adherence.

Patent and Exclusivity Considerations

While TRULANCE’s patents safeguard market exclusivity until approximately 2025-2027, upcoming patent expirations and potential biosimilar development could erode market share, intensifying price competition.

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Financial Trajectory Analysis

Revenue Estimates and Growth Trends

Initial sales after approval were modest but grew steadily, bolstered by increasing prescriptions. In 2021, sales in the U.S. reached approximately $65 million, with projections estimating a compound annual growth rate (CAGR) of 7-10% over the next five years, driven by expanding indications and awareness campaigns [2].

Market Penetration and Expansion Opportunities

Beyond CIC and IBS-C, upcoming research explores TRULANCE in postoperative ileus and pediatric cases, potentially unlocking new revenue streams. Geographic expansion into Europe and Asia faces regulatory hurdles but offers substantial long-term growth if navigated successfully.

Pricing and Reimbursement Impact

Pricing elasticity influences revenue; reductions due to pressure from payers and insurers could dampen growth. Conversely, positive outcomes from real-world evidence (RWE) may bolster formulary placements, driving sales.

Potential Impact of Biosimilars and Generic Competition

The expiration of patent protections might introduce biosimilars or generics, impacting revenue. Strategic patent extensions and R&D investments in next-generation GC-C receptor agonists remain vital to sustain market dominance.

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Future Outlook and Strategic Considerations

Pipeline and New Indications

Amgen’s ongoing trials investigating TRULANCE for pediatric use and other GI conditions could expand its therapeutic footprint. These programs could positively influence long-term sales trajectories by broadening application and reimbursement coverage.

Partnerships and Collaborations

Collaborations with payers and healthcare providers can improve market access. Additionally, investments in patient support programs and digital health initiatives can enhance adherence and brand loyalty.

Regulatory and Competitive Risks

Potential regulatory changes, such as price control policies, could impact profitability. Competition from innovative non-GC-C agents or emerging therapies targeting different mechanisms might also threaten market share.

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Conclusion

TRULANCE’s market dynamics are shaped by a confluence of clinical efficacy, competitive positioning, regulatory status, and health economics. While currently demonstrating steady growth within its niche, its future trajectory hinges on patent protections, pipeline expansion, and evolving healthcare policies that influence drug pricing and reimbursement. Strategic adaptability and continuous evidence generation will be paramount for sustained financial success.

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Key Takeaways

• Growing demand for constipation therapies due to demographic shifts and increasing prevalence of GI disorders underpins TRULANCE’s market potential.
• Competitive pressure from linaclotide, lubiprostone, and emerging therapies necessitates strategic positioning through differentiated safety, efficacy, and pricing.
• Patent expirations around 2025-2027 pose risks to revenue, emphasizing the need for pipeline development and market expansion.
• Real-world evidence and expanded indications could significantly enhance market adoption and long-term financial outlook.
• Regulatory and reimbursement frameworks will critically influence sales trajectories, highlighting the importance of engaging payers and policymakers.

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FAQs

Q1: What distinguishes TRULANCE from other constipation treatments?
A: TRULANCE selectively activates GC-C receptors, leading to increased intestinal fluid secretion with a favorable safety profile and once-daily dosing, offering advantages over traditional laxatives and some other newer agents.

Q2: How does patent expiration impact TRULANCE’s market prospects?
A: Patent cliffs around 2025-2027 could enable biosimilar entry, heightening competition and potentially reducing market share and pricing power.

Q3: What are the key growth opportunities for TRULANCE?
A: Expansion into pediatric markets, additional GI conditions, and geographic regions outside the U.S. present significant potential; ongoing clinical trials are critical to these prospects.

Q4: How does reimbursement influence TRULANCE’s market penetration?
A: Positive payer coverage and inclusion in formularies facilitate physician prescribing and patient access, directly affecting sales growth.

Q5: What risks could hinder TRULANCE’s future financial performance?
A: Competitive drug entries, regulatory reforms affecting price and reimbursement, and patent expiry-related generic competition pose primary risks.

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References

[1] American College of Gastroenterology. "Prevalence of Chronic Constipation." 2020.
[2] IMS Health Data. "Pharmaceutical Sales in Gastrointestinal Therapeutics," 2021.