TRULANCE Drug Patent Profile

When do Trulance patents expire, and what generic alternatives are available?

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 eight 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
Patent Applications:	65
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

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
Synergy Pharmaceuticals 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.

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
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

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
Salix	TRULANCE	plecanatide	TABLET;ORAL	208745-001	Jan 19, 2017

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
Australia	2018286626	Formulations Of Guanylate Cyclase C Agonists And Methods Of Use
Brazil	112015030326
Eurasian Patent Organization	038977	СОСТАВЫ АГОНИСТОВ ГУАНИЛАТЦИКЛАЗЫ С И СПОСОБЫ ПРИМЕНЕНИЯ (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE)
Eurasian Patent Organization	200301070
World Intellectual Property Organization (WIPO)	02078683

Market Dynamics and Financial Trajectory for TRULANCE

Introduction

TRULANCE, developed by Synergy Pharmaceuticals, is a prescription drug approved by the FDA in January 2017 for the treatment of chronic idiopathic constipation (CIC). Since its launch, the drug has navigated a competitive market landscape, influencing both the market dynamics and the financial performance of Synergy Pharmaceuticals.

Market Landscape

The market for CIC treatments was previously dominated by a few key players, including Linzess (co-marketed by Allergan and Ironwood Pharmaceuticals) and Amitiza (by Takeda Pharmaceutical and Sucampo). The entry of TRULANCE marked a significant shift, as it expanded the market rather than cannibalizing existing market share[1].

Competitive Advantage

Synergy Pharmaceuticals believed that the introduction of new drugs like TRULANCE would grow the overall market. This was supported by data showing that the prescription constipation drug market doubled from $642 million in 2013 to $1.5 billion in 2016[1].

Marketing and Promotion

To stand out in a competitive market, Synergy and its competitors increased their marketing investments. For instance, Allergan and Ironwood boosted their ad spend for Linzess by 8% from 2015 to 2016, reaching $93 million in 2016[1].

Sales Performance

Since its launch on March 20, 2017, TRULANCE has shown promising sales growth. In the third quarter of 2018, TRULANCE U.S. net sales were $11.1 million, a 122.0% increase compared to $5.0 million in the third quarter of 2017. The number of 30-count packs dispensed also increased by 104.7% to 63,085 in the same period[2].

Prescription Trends

New prescriptions for TRULANCE have been on the rise. In the third quarter of 2018, 23,560 new prescriptions were filled, a 46.4% increase from the prior year quarter. Since its launch, a total of 250,684 TRULANCE 30-count packs have been dispensed, with a normalized prescription volume increasing by 38.4% on average quarter-over-quarter[2].

Market Access and Formulary Wins

Synergy Pharmaceuticals has made significant strides in improving market access for TRULANCE. New formulary wins in 2018 and 2019 across major U.S. Commercial, Medicare Part D, and Managed Medicaid plans have enhanced patient access. For example, Express Scripts and OptumRx have included TRULANCE in their formularies, and UnitedHealthcare has improved its coverage status for TRULANCE[4].

Financial Performance

Despite the growth in sales, Synergy Pharmaceuticals faced financial challenges. The company reported a net loss of $34.5 million in the third quarter of 2018, although this was an improvement from the $48.9 million net loss in the third quarter of 2017. Total operating expenses decreased by 27.8% to $36.8 million in the third quarter of 2018 compared to the same period in 2017[2].

Revenue Projections

Synergy projected TRULANCE total net sales for 2018 to be between $42.0 million to $47.0 million, which was below the minimum revenue covenant of $61.0 million set forth in its term loan agreement with CRG. This led the company to evaluate opportunities to reduce cash expenditures and explore strategic alternatives to enhance shareholder value[2].

Licensing Agreements

In addition to domestic sales, Synergy Pharmaceuticals secured a licensing agreement with Luoxin Pharmaceutical Group Co., Ltd. for TRULANCE in mainland China, Hong Kong, and Macau. This agreement included an upfront payment of $10.1 million, which was recorded as deferred revenue as of September 30, 2018[2].

Strategic Review

Synergy Pharmaceuticals has been undergoing a strategic review to identify opportunities that maximize the long-term value of the company. This process involves evaluating various strategic alternatives, including potential partnerships or restructuring, to better align with anticipated revenues and available capital[2][4].

Challenges and Opportunities

Competitive Market Access Environment

One of the significant challenges faced by TRULANCE is the highly competitive market access environment. Despite new formulary wins, the overall market growth has been slower than anticipated, affecting TRULANCE's sales projections[2].

Regulatory and Market Dynamics

The regulatory landscape and market dynamics play crucial roles in the success of TRULANCE. The drug's approval and subsequent formulary inclusions have been key factors in its market penetration. However, the competitive nature of the CIC treatment market continues to pose challenges[1][4].

Key Takeaways

• Market Expansion: The entry of TRULANCE has expanded the CIC treatment market rather than cannibalizing existing market share.
• Sales Growth: TRULANCE has shown significant sales growth, with a 122.0% increase in U.S. net sales in the third quarter of 2018 compared to the same period in 2017.
• Market Access: New formulary wins have improved patient access to TRULANCE across various health plans.
• Financial Challenges: Despite sales growth, Synergy Pharmaceuticals faces financial challenges, including a net loss and the need to reduce cash expenditures.
• Strategic Review: The company is undergoing a strategic review to maximize long-term value and align with anticipated revenues.

FAQs

What is TRULANCE used for?

TRULANCE is a prescription drug used for the treatment of chronic idiopathic constipation (CIC).

When was TRULANCE approved by the FDA?

TRULANCE was approved by the FDA in January 2017.

How has TRULANCE performed in terms of sales since its launch?

TRULANCE has shown significant sales growth, with U.S. net sales increasing by 122.0% in the third quarter of 2018 compared to the same period in 2017.

What are some of the key formulary wins for TRULANCE?

TRULANCE has been included in formularies by Express Scripts, OptumRx, and UnitedHealthcare, improving its coverage status across major U.S. health plans.

What financial challenges is Synergy Pharmaceuticals facing with TRULANCE?

Synergy Pharmaceuticals is facing financial challenges, including a net loss and the need to reduce cash expenditures due to slower-than-anticipated market growth and a highly competitive market access environment.

Sources

1. MMM-Online: "Facing a competitive market, Synergy looks to stand out with unbranded emojis."
2. Business Wire: "Synergy Pharmaceuticals Reports Third Quarter 2018 Financial Results and Business Update."
3. GlobalData: "Net Present Value Model: Trulance - GlobalData."
4. BioSpace: "Synergy Pharmaceuticals Strengthens Coverage for TRULANCE with Key New Market Access Wins."
5. BioSpace: "Synergy Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results and Business Update."