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Last Updated: December 25, 2024

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TRULANCE Drug Patent Profile


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Which patents cover Trulance, and what generic alternatives are available?

Trulance is a drug marketed by Salix and is included in one NDA. There are nine 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

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Drug patent expirations by year for TRULANCE
Drug Prices for TRULANCE

See drug prices for TRULANCE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRULANCE
Generic Entry Date for TRULANCE*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all TRULANCE clinical trials

Pharmacology for TRULANCE
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 eleven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRULANCE is ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 9,616,097 ⤷  Subscribe Y ⤷  Subscribe
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 10,011,637 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 14274812
Patent: Ultra-pure agonists of guanylate cyclase C, method of making and using same
Estimated Expiration: ⤷  Subscribe

Patent: 18226473
Patent: Ultra-Pure Agonists Of Guanylate Cyclase C, Method Of Making And Using Same
Estimated Expiration: ⤷  Subscribe

Patent: 20205349
Patent: Ultra-pure agonists of guanylate cyclase C, method of making and using same
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2015030326
Patent: AGONISTAS ULTRAPUROS DE GUANILATO CICLASE C, MÉTODO DE FABRICAR E USAR OS MESMOS
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 13737
Patent: AGONISTES ULTRA-PURS DE GUANYLATE CYCLASE C, LEUR PROCEDE DE PRODUCTION ET D'UTILISATION (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Subscribe

China

Patent: 5764916
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 3388007
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0240805
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 1592263
Patent: УЛЬТРАЧИСТЫЕ АГОНИСТЫ ГУАНИЛАТЦИКЛАЗЫ C, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 04138
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 24697
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 21959
Patent: 鳥苷酸環化酶 的超純激動劑、製備和使用所述激動劑的方法 (ULTRA-PURE AGONISTS OF GUANYLATE YCLASE , METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 2939
Patent: אגוניסטים של גואנילט ציקלז c בדרגת זקוק גבוה, שיטות לייצורם ושימושים בהם (Ultra-pure agonists of guanylate cyclase c, method of making and using same)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 06491
Estimated Expiration: ⤷  Subscribe

Patent: 16522216
Patent: グアニル酸シクラーゼCの超高純度アゴニスト、その作成および使用方法
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 04138
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 04138
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 632
Patent: ULTRA-PREČIŠĆENI AGONISTI GUANILAT-CIKLAZE C, POSTUPAK NJIHOVE PRIPREME I UPOTREBE (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 04138
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2272746
Estimated Expiration: ⤷  Subscribe

Patent: 160039577
Patent: 구아닐레이트 사이클라제 C의 초순수 작용제, 및 이의 제조 및 사용 방법 (ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 81866
Estimated Expiration: ⤷  Subscribe

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
Eurasian Patent Organization 201592263 УЛЬТРАЧИСТЫЕ АГОНИСТЫ ГУАНИЛАТЦИКЛАЗЫ C, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ ⤷  Subscribe
Eurasian Patent Organization 038977 СОСТАВЫ АГОНИСТОВ ГУАНИЛАТЦИКЛАЗЫ С И СПОСОБЫ ПРИМЕНЕНИЯ (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE) ⤷  Subscribe
European Patent Office 2621509 PRÉPARATIONS D'AGONISTES DU GUANYLATE CYCLASE-C ET MÉTHODES D'UTILISATION (FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHODS OF USE) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

TRULANCE Market Analysis and Financial Projection Experimental

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."

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.