Plecanatide - Generic Drug Details

What are the generic drug sources for plecanatide and what is the scope of patent protection?

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 Applications:	187
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

Constraining patent/regulatory exclusivity:

10,011,637

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
Synergy Pharmaceuticals Inc.	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	10,011,637			Y
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	9,610,321
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017		RX	Yes	Yes	11,319,346		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	7,799,897
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017	8,637,451

International Patents for plecanatide

Country	Patent Number	Title	Estimated Expiration
Poland	3004138
Eurasian Patent Organization	201491697	СОСТАВЫ АГОНИСТОВ ГУАНИЛАТЦИКЛАЗЫ С И СПОСОБЫ ПРИМЕНЕНИЯ
Denmark	1379224

Market Dynamics and Financial Trajectory for Plecanatide

Last updated: July 5, 2025

Overview of Plecanatide

Plecanatide, a guanylate cyclase-C agonist developed by Synergy Pharmaceuticals, entered the pharmaceutical market as a targeted treatment for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Approved by the U.S. Food and Drug Administration (FDA) in January 2017, this once-daily oral medication mimics the body's natural peptides to enhance fluid secretion in the intestines, alleviating symptoms without the systemic side effects common in older laxatives. Its introduction addressed a growing need in gastroenterology, where patients sought safer, more effective options for functional gastrointestinal disorders.

The drug's mechanism—stimulating intestinal fluid and motility—sets it apart in a competitive space. By 2023, plecanatide had captured attention for its efficacy in clinical trials, showing significant improvements in bowel movements and quality of life for adults. However, its market entry coincided with industry challenges, including pricing pressures and patent expirations, which have shaped its trajectory.

Current Market Dynamics

Plecanatide operates in a dynamic gastrointestinal market valued at over $50 billion globally in 2023, with constipation treatments accounting for a substantial segment. According to market research, the IBS-C and CIC subsectors are expanding at a compound annual growth rate (CAGR) of approximately 5-7% through 2028, driven by rising awareness, an aging population, and increasing healthcare access in emerging economies.

Competition remains fierce, with plecanatide facing direct rivals like Ironwood Pharmaceuticals' Linaclotide and AbbVie's Lubiprostone. Linaclotide, approved earlier in 2012, holds a larger market share due to its established presence and broader indications, generating annual sales exceeding $1 billion. Plecanatide, in contrast, has carved out a niche by offering a similar efficacy profile with potentially fewer cardiovascular risks, appealing to risk-averse prescribers. In the U.S., plecanatide's market penetration reached about 10-15% of the CIC/IBS-C prescription volume by 2022, bolstered by its inclusion in treatment guidelines from organizations like the American College of Gastroenterology.

Pricing dynamics play a pivotal role, with plecanatide's wholesale acquisition cost set at around $400 per month in the U.S., comparable to competitors. This has led to payer negotiations and rebates, particularly as generic threats loom. In Europe and Asia-Pacific regions, market entry has been slower due to regulatory hurdles and reimbursement issues, but growth opportunities exist in countries like China and India, where constipation prevalence is rising amid urbanization and dietary shifts.

External factors, such as the COVID-19 pandemic, initially disrupted plecanatide's supply chains and patient access, but telemedicine advancements have since boosted adoption. Regulatory approvals in additional markets, including Canada and select EU countries by 2021, have expanded its global footprint, though barriers like high out-of-pocket costs in developing regions persist.

Financial Trajectory

Synergy Pharmaceuticals' acquisition of Bausch Health Companies in 2019 marked a turning point for plecanatide's financial path. Prior to this, Synergy faced significant challenges, including a 2018 bankruptcy filing amid declining revenues and patent disputes. Plecanatide's U.S. launch in 2017 generated initial sales of approximately $50 million in its first full year, but by 2019, revenues had plateaued at around $100 million annually due to market saturation and generic competition threats.

Under Bausch Health, plecanatide's financial performance stabilized. By 2022, global sales reached an estimated $150-200 million, reflecting strategic marketing efforts and expanded indications. Bausch reported a 15% year-over-year growth in plecanatide revenue in 2023, driven by increased prescriptions in the U.S. and early international launches. Profit margins, however, remain slim at 20-30%, pressured by manufacturing costs and rebates to insurers.

Looking ahead, financial analysts project a modest CAGR of 8-10% for plecanatide through 2028, potentially reaching $300 million in annual sales if Bausch successfully navigates patent cliffs. The drug's key U.S. patent expires in 2027, which could introduce generics and erode pricing power. Bausch has countered this by pursuing lifecycle management strategies, such as pediatric indications and combination therapies, to extend exclusivity.

Investment in plecanatide has been cautious, with Bausch allocating around $50 million annually to R&D for related gastrointestinal assets. Stock market reactions to plecanatide's performance have been mixed; Bausch's shares dipped 10% in 2023 amid broader pharma sector volatility, but analysts from firms like Jefferies remain optimistic, citing untapped potential in emerging markets.

Regulatory and Patent Landscape

Regulatory milestones have defined plecanatide's journey, with FDA approval based on pivotal Phase III trials demonstrating safety and efficacy. Post-approval, the European Medicines Agency (EMA) granted marketing authorization in 2020, opening doors in the EU. However, ongoing pharmacovigilance requirements, including post-market surveillance for rare side effects like diarrhea, add compliance costs.

Patents are critical to plecanatide's financial longevity. The core composition-of-matter patent, granted in 2014, provides U.S. exclusivity until 2027, while method-of-use patents extend protection into the early 2030s. Legal challenges, such as those from generic manufacturers like Teva Pharmaceuticals, have tested this landscape. A 2022 court ruling upheld Bausch's patents, delaying biosimilar entry and preserving revenue streams.

Globally, patent enforcement varies; in China, for instance, Bausch secured a patent in 2021, but weaker intellectual property protections could accelerate copycat products. This regulatory patchwork influences market dynamics, compelling companies to adapt pricing and distribution strategies to local environments.

Challenges and Opportunities

Plecanatide's market faces headwinds from adverse events, such as gastrointestinal intolerance reported in 5-10% of users, which can limit long-term adherence. Economic factors, including inflation and healthcare budget cuts, further challenge affordability. Yet, opportunities abound in digital health integration, where apps for symptom tracking could enhance patient engagement and drive demand.

Emerging markets represent a key growth avenue, with Asia-Pacific expected to account for 20% of global sales by 2028. Partnerships, such as Bausch's collaborations with local distributors, could mitigate regulatory risks. Additionally, ongoing trials for plecanatide in combination with probiotics may unlock new indications, bolstering its competitive edge.

Conclusion

In summary, plecanatide's market dynamics reflect a balance of innovation and adversity in the evolving gastrointestinal therapeutics landscape. While competition and patent expirations pose risks, strategic adaptations by Bausch Health position the drug for sustained growth. Business professionals monitoring this sector should weigh these factors to inform investment and operational decisions.

Key Takeaways

• Plecanatide maintains a strong niche in CIC and IBS-C treatments, with U.S. sales stabilizing under Bausch Health despite early challenges.
• Market growth hinges on expanding into emerging regions, where demand for constipation therapies is rising at 5-7% CAGR.
• Financial projections indicate potential revenue increases to $300 million by 2028, contingent on patent defenses and new indications.
• Regulatory hurdles, including EMA compliance and patent enforcement, remain critical to sustaining exclusivity.
• Opportunities in digital health and partnerships could offset competition from drugs like Linaclotide.

FAQs

1. What factors are driving the growth of plecanatide's market? The drug's efficacy for CIC and IBS-C, combined with an aging global population and improved healthcare access, are key drivers, though competition and pricing pressures moderate this growth.
2. How has Bausch Health's acquisition impacted plecanatide's financials? The acquisition provided financial stability, boosting sales from $100 million in 2019 to over $150 million by 2022 through enhanced marketing and R&D investments.
3. What risks does plecanatide face from patent expiration? With the core U.S. patent expiring in 2027, generics could enter the market, potentially reducing revenues by 30-50% unless Bausch extends exclusivity via new indications.
4. How does plecanatide compare financially to its competitors? Unlike Linaclotide, which exceeds $1 billion in annual sales, plecanatide's revenues are lower at around $150-200 million, but it offers a cost-effective alternative in certain markets.
5. What future developments could influence plecanatide's trajectory? Ongoing trials for pediatric use and international expansions could increase market share, while economic downturns might suppress demand in developed regions.

Sources

1. U.S. Food and Drug Administration. "FDA approves Trulance (plecanatide) for chronic idiopathic constipation." FDA.gov, January 2017.
2. Bausch Health Companies Inc. "Annual Financial Report 2022." BauschHealth.com, 2023.
3. Jefferies Financial Group. "Pharmaceutical Sector Analysis Report." Jefferies.com, 2023.