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
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
European Patent Office	3004138	AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCÉDÉ DE PRODUCTION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Israel	242939
Spain	2330312
Canada	2867292	FORMULATIONS D'AGONISTES DE LA GUANYLATE CYCLASE C ET PROCEDES D'UTILISATION (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE)
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)
Canada	2441970	AGONISTES DU RECEPTEUR DU TYPE GUANYLATE CYCLASE SERVANT AU TRAITEMENT DE L'INFLAMMATION TISSULAIRE ET DE LA CARCINOGENESE (GUANYLATE CYCLASE RECEPTOR AGONISTS FOR THE TREATMENT OF TISSUE INFLAMMATION AND CARCINOGENESIS)

Market Dynamics and Financial Trajectory for Plecanatide

Last updated: February 15, 2026

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Summary

Plecanatide, developed by Synergy Pharmaceuticals (later acquired by Bausch Health), is a gastrointestinal drug approved by the FDA for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Its market landscape has evolved with approval milestones, competitive pressures, and emerging pipeline developments, influencing its financial outlook.

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Regulatory Status and Market Adoption

Approval Timeline:
Plecanatide gained FDA approval in January 2017 for CIC and IBS-C in adults. The drug's indication extension to pediatric populations in July 2021 expanded its usage but faced regulatory delays, with the FDA requesting additional data.

Market Penetration:
Initial adoption was moderate, constrained by competition from linaclotide (Linzess/Constella), another guanylate cyclase-C (GC-C) agonist. As of 2022, Plecanatide held an estimated 15-20% share in the IBS-C space and 10-12% in CIC, according to IQVIA sales data.

Commercial Challenges:
Brand recognition lagged against linaclotide. Physicians favor linaclotide’s established efficacy profile and early market presence. Efforts by Bausch to promote Plecanatide increased sales but did not significantly displace the competitor.

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Market Size and Revenue

Market Size:
The global constipation medication market was valued at approximately $2.4 billion in 2022. The IBS-C segment comprised roughly 30% of this market. The US dominates, representing approximately 80% of sales.

Revenue Figures:

• 2019: Plecanatide generated approximately $116 million in sales (Bausch annual report).
• 2020: Sales increased marginally to about $124 million.
• 2021: Reach estimates of ~$130 million, with growth driven by expanded indications.
• 2022: Sales plateaued or declined slightly due to competitive pressures and generic linaclotide pricing.

Future Revenue Potential:
The projected compound annual growth rate (CAGR) for Plecanatide sales is around 3-4% through 2025, assuming increased penetration and approval of pediatric indications.

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Competitive Landscape

Main Competitors:

• Linaclotide (AbbVie, Ironwood Pharmaceuticals): Introduced in 2012, holds ~70-75% of the US IBS-C market.
• Lubiprostone (Amitiza): Approved for CIC and IBS-C but less utilized due to side effects.

Pipeline Developments:
No significant pipeline candidates derived from Plecanatide have been announced. A shift toward combination therapies and personalized medicine may challenge its dominance.

Pricing Dynamics:
Brand-name Plecanatide retails around $400 for a 30-day supply, while generics of linaclotide cost approximately $150. This price disparity influences prescriber preference.

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Financial Trajectory Factors

Patent and Exclusivity:
Plecanatide's exclusivity period extends to 2032, which offers a window for sustained revenue. The absence of a generic alternative limits downward price pressures initially.

Pipeline and Lifecycle Management:
Limited pipeline extensions restrict revenue growth. Lifecycle management strategies such as line extensions or new formulations are potential avenues but have not been publicly pursued.

Market Expansion:
International approvals are pending, primarily in Europe and Asia, which could augment revenue. However, regulatory hurdles and local competition may slow these efforts.

Pricing and Reimbursement:
Market access depends on insurer reimbursement policies. Prices face resistance from payers demanding cost-effectiveness evidence over competitors.

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Key Financial Risks and Opportunities

Risks:

• Loss of market share to generics or new entrants.
• Regulatory delays or restrictions in off-label uses.
• Pricing pressures from payers.

Opportunities:

• Growth via pediatric indications and longer-term safety data.
• Expansion into new markets with unmet GI conditions.
• Potential partnerships for combination therapies or new delivery formats.

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Key Takeaways

• Plecanatide’s sales are stable but limited by competing drugs and pricing.
• Market growth depends on expanding indications, especially pediatric use.
• The patent exclusivity until 2032 secures revenue, but generic competition looms afterward.
• International expansion offers growth potential but faces regulatory and reimbursement challenges.
• Pipeline stagnation restricts long-term upside unless new formulations or indications emerge.

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Frequently Asked Questions

1. What is Plecanatide’s primary medical use?
   It treats chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.

2. How does Plecanatide compare price-wise to competitors?
   It costs around $400 for a month’s supply, while linaclotide, its main competitor, costs about $150 for the same period.

3. What is the projected revenue for Plecanatide through 2025?
   Around $130 million in 2022 with a projected CAGR of 3-4%, indicating steady but moderate growth.

4. What are the main barriers to expanding Plecanatide’s market share?
   Competition from generic linaclotide, pricing disparities, and limited pipeline extensions.

5. What future developments could influence Plecanatide’s financial outlook?
   Approval of pediatric indications, international market entry, and formulation innovations.

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Citations

[1] IQVIA. "Pharmaceutical Market Data," 2022.
[2] Bausch Health Annual Report, 2022.
[3] FDA Approvals and Indication Data, 2017–2021.
[4] MarketResearch.com, "Constipation Medications Market Analysis," 2022.