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 nine 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:	9
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

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
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
Australia	2018286626	Formulations Of Guanylate Cyclase C Agonists And Methods Of Use
Eurasian Patent Organization	201592263	УЛЬТРАЧИСТЫЕ АГОНИСТЫ ГУАНИЛАТЦИКЛАЗЫ C, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ
European Patent Office	2825188	FORMULATIONS D'AGONISTES DE LA GUANYLATE CYCLASE C ET PROCÉDÉS D'UTILISATION (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE)
Australia	2011302006	Formulations of guanylate cyclase C agonists and methods of use
China	113388007	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 methods 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)
Australia	2020205349	Ultra-pure agonists of guanylate cyclase C, method of making and using same

Plecanatide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Plecanatide

Introduction

Plecanatide, a synthetic peptide and guanylate cyclase-C (GC-C) agonist, has been making significant waves in the pharmaceutical industry, particularly in the treatment of gastrointestinal disorders. Here, we delve into the market dynamics and financial trajectory of plecanatide, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Projections

The plecanatide market has shown promising growth, with a valuation of USD 100 million in 2023. It is projected to reach USD 194.87 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10% from 2024 to 2031[1].

Segmentation and Applications

The market for plecanatide is segmented based on type (tablets, capsules, powder, injectable) and application (chronic idiopathic constipation treatment, irritable bowel syndrome treatment, gastrointestinal disorder management, clinical trials, and research & development). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Therapeutic Indications

Plecanatide is primarily indicated for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. Its mechanism of action involves increasing intestinal fluid secretion without altering electrolyte levels, making it an effective and safe therapeutic option for these conditions[2][5].

Market Drivers

Several factors are driving the growth of the plecanatide market:

Increasing Prevalence of Gastrointestinal Disorders

The rising prevalence of CIC and IBS-C globally is a significant driver. Traditional therapies often fail to provide adequate relief, making plecanatide a sought-after alternative[1].

Efficacy and Safety Profile

Plecanatide's unique mechanism of action and favorable safety profile have enhanced its adoption among both patients and healthcare providers. Its ability to improve bowel movements without causing significant side effects is a key advantage[1].

Clinical Trials and Research

Ongoing clinical trials exploring plecanatide's potential in other gastrointestinal conditions, such as ulcerative colitis, are expected to expand its therapeutic applications and drive market growth[1].

Reimbursement Policies

Advantageous reimbursement policies and increasing healthcare costs have also contributed to the market's expansion. Improved formulary coverage, such as the wins announced by Synergy Pharmaceuticals in 2018, has enhanced patient access and supported sales growth[2].

Competitive Landscape

The plecanatide market is characterized by a mix of established and emerging players. Key companies include Synergy Pharmaceuticals, Bausch Health, Allergan, Takeda Pharmaceutical, Ironwood Pharmaceuticals, and others. These companies are engaged in various market-related activities such as new product launches, collaborations, and acquisitions to maintain their competitive edge[1][4].

Financial Performance

The financial trajectory of plecanatide is marked by steady growth. The drug's inclusion in major formularies, such as Express Scripts Medicare Part D Formulary and OptumRx formularies, has significantly improved its market access and financial performance. For instance, Synergy Pharmaceuticals' efforts to strengthen market access for TRULANCE (plecanatide) have been successful, as evidenced by new formulary wins in 2018[2].

Regional Market Dynamics

The market dynamics vary across different geographical regions:

North America

North America is a significant market for plecanatide, driven by high healthcare spending and a large patient population suffering from CIC and IBS-C. The region has seen substantial formulary wins, enhancing the drug's accessibility[1][2].

Europe and Asia-Pacific

These regions are also experiencing growth, driven by increasing awareness of plecanatide's efficacy and the expanding patient base. Local pharmaceutical companies and research institutions are playing a crucial role in promoting the drug's use in these markets[1].

Challenges and Opportunities

While the market for plecanatide is growing, there are several challenges and opportunities to consider:

Challenges

• Competition: The gastrointestinal drug market is highly competitive, with various treatments available for CIC and IBS-C.
• Regulatory Hurdles: Ensuring compliance with FDA regulations and obtaining approvals for new indications can be challenging.
• Patient Education: Raising awareness among patients and healthcare providers about the benefits of plecanatide is essential for market growth[2].

Opportunities

• Expanding Therapeutic Applications: Ongoing clinical trials could lead to approvals for additional gastrointestinal conditions, expanding the market.
• Emerging Markets: Growing healthcare needs in emerging economies present opportunities for market expansion.
• Collaborations and Acquisitions: Strategic partnerships and acquisitions can enhance market presence and drive innovation[1][4].

Key Takeaways

• Market Growth: The plecanatide market is expected to grow significantly, reaching USD 194.87 million by 2031.
• Therapeutic Indications: Plecanatide is primarily used for treating CIC and IBS-C, with potential expansion into other gastrointestinal conditions.
• Market Drivers: Increasing prevalence of gastrointestinal disorders, favorable efficacy and safety profile, and advantageous reimbursement policies are key drivers.
• Competitive Landscape: The market is characterized by a mix of established and emerging players, with significant competition and opportunities for growth.
• Regional Dynamics: North America, Europe, and Asia-Pacific are key regions driving market growth.

FAQs

What is plecanatide used for?

Plecanatide is primarily used for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults.

Who are the key players in the plecanatide market?

Key players include Synergy Pharmaceuticals, Bausch Health, Allergan, Takeda Pharmaceutical, Ironwood Pharmaceuticals, and others.

What is the projected market size of plecanatide by 2031?

The plecanatide market is projected to reach USD 194.87 million by 2031, growing at a CAGR of 10% from 2024 to 2031.

What are the main drivers of the plecanatide market?

The main drivers include the increasing prevalence of gastrointestinal disorders, plecanatide's favorable efficacy and safety profile, ongoing clinical trials, and advantageous reimbursement policies.

Are there any challenges facing the plecanatide market?

Yes, challenges include competition from other gastrointestinal treatments, regulatory hurdles, and the need for patient education about the benefits of plecanatide.

Sources

1. Market Research Intellect - Global Plecanatide Market Size and Projections
2. Business Wire - Synergy Pharmaceuticals Strengthens Coverage for TRULANCE
3. Wiley Online Library - FDA's stamp of approval: Unveiling peptide breakthroughs
4. Market Research Intellect - Global Plecanatide API Market Size, Scope And Forecast Report
5. Patsnap Synapse - Plecanatide - Drug Targets, Indications, Patents