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SYMPROIC Drug Patent Profile

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

Symproic is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-four patent family members in twenty-seven countries.

The generic ingredient in SYMPROIC is naldemedine tosylate. One supplier is listed for this compound. Additional details are available on the naldemedine tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Symproic

Symproic was eligible for patent challenges on March 23, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 13, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SYMPROIC

International Patents:	74
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	6
Drug Prices:	Drug price information for SYMPROIC
What excipients (inactive ingredients) are in SYMPROIC?	SYMPROIC excipients list
DailyMed Link:	SYMPROIC at DailyMed

See drug prices for SYMPROIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SYMPROIC

NDA:

208854

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.

Pharmacology for SYMPROIC

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for SYMPROIC

SYMPROIC is protected by four 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
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y

International Patents for SYMPROIC

When does loss-of-exclusivity occur for SYMPROIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Denmark

European Patent Office

Japan

Poland

Spain

Taiwan

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 SYMPROIC around the world.

Country	Patent Number	Title	Estimated Expiration
China	101228172	6,7-unsaturated-7-carbamoyl substituted morphinan derivative
World Intellectual Property Organization (WIPO)	2006126529
China	103298819	Crystalline 6,7-unsaturated-7-carbamoyl morphinane derivative, and method for producing same

Supplementary Protection Certificates for SYMPROIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	C201930045	Spain		PRODUCT NAME: NADELMEDINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
1889848	2019/038	Ireland		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	CA 2019 00035	Denmark		PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220

SYMPROIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Symproic

Introduction

Symproic, also known as naldemedine, is a medication used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Developed by Shionogi Inc., Symproic has been a significant player in the OIC market, influencing both market dynamics and financial trajectories in the pharmaceutical industry.

Market Overview

The global opioid-induced constipation market is expected to grow at a compound annual growth rate (CAGR) of 4.6% from 2023 to 2030, driven primarily by the increasing number of geriatric patients prescribed opioid analgesics for chronic non-cancer pain[1].

Product Overview

Symproic is a mu-opioid receptor antagonist, which works by blocking the opioid receptors in the gastrointestinal tract without affecting the analgesic effects of opioids in the central nervous system. This mechanism of action makes it an effective treatment for OIC without compromising pain management[4].

Market Segmentation

The OIC market is segmented into over-the-counter (OTC) and prescription medications, with the prescription segment dominating due to its higher efficacy and potency. Symproic falls under the prescription category, which is expected to continue its dominance over the forecast period[1].

Competitive Landscape

Symproic competes in a market that includes other mu-opioid receptor antagonists such as Methylnaltrexone (Relistor), Naloxegol (Movantik), and Alvimopan (Entereg). The competitive landscape is characterized by the availability of various product types and ongoing research activities, which drive market growth and innovation[1].

Regional Performance

North America, particularly the United States, accounts for the largest market share due to the high incidence of gastrointestinal illnesses among older patients and the significant use of opioids. Symproic's sales in this region are bolstered by these factors, contributing to its overall market performance[1].

Financial Performance

Shionogi Inc.'s financial reports highlight the significant contribution of Symproic to the company's revenue. In the fiscal year 2017, the sales growth of new products, including Symproic, Intuniv®, and XofluzaTM, was a key factor in the company's financial success. The operating income and ordinary income saw record-high levels, partly due to the strong sales performance of these drugs[5].

Sales Growth

Symproic has been one of the new products driving sales growth for Shionogi Inc. The company reported an increase in sales due to the growth of strategic products, including Symproic, which has been a key contributor to the company's revenue growth[5].

Market Forecast

Historical and forecasted sales data indicate that Symproic has been performing well in the market. The "Symproic - Drug Insight, 2019" report provides comprehensive information on Symproic's sales, including historical data and forecasts up to 2021. This report suggests that Symproic's market performance has been robust, with continued growth expected due to its efficacy and market demand[4].

Regulatory and Clinical Milestones

Symproic has achieved several regulatory milestones, including its approval by regulatory bodies in the United States and Europe. Clinical trials have demonstrated its safety and efficacy in treating OIC, further solidifying its position in the market[4].

Partnerships and Collaborations

Shionogi Inc. has engaged in various partnerships and collaborations to enhance the market presence of Symproic. These partnerships have helped in expanding the drug's reach and improving its market competitiveness[4].

SWOT Analysis

A SWOT analysis of Symproic highlights its strengths, such as its unique mechanism of action and strong clinical trial data. However, it also faces challenges like competition from other mu-opioid receptor antagonists and the potential impact of generic competitors. The analysis also points out opportunities for growth in emerging markets and the need to address potential threats such as regulatory changes and market competition[4].

Financial Projections and Future Outlook

Given the growing demand for OIC treatments and the strong performance of Symproic, Shionogi Inc. is expected to continue benefiting from the drug's sales. The company's financial forecasts indicate a positive outlook, with continued investment in research and development to further enhance Symproic's market position[5].

Key Takeaways

• Market Growth: The OIC market is expected to grow at a CAGR of 4.6% from 2023 to 2030.
• Product Efficacy: Symproic's unique mechanism of action makes it an effective treatment for OIC.
• Regional Performance: North America, particularly the U.S., is a key market for Symproic.
• Financial Performance: Symproic has significantly contributed to Shionogi Inc.'s revenue growth.
• Regulatory Milestones: Symproic has achieved several regulatory approvals and has strong clinical trial data.
• Competitive Landscape: Symproic competes with other mu-opioid receptor antagonists but maintains a strong market position.

FAQs

What is Symproic used for?

Symproic (naldemedine) is used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

How does Symproic work?

Symproic works by blocking the opioid receptors in the gastrointestinal tract without affecting the analgesic effects of opioids in the central nervous system.

What is the market outlook for Symproic?

The market outlook for Symproic is positive, with the OIC market expected to grow at a CAGR of 4.6% from 2023 to 2030.

Which region dominates the market for Symproic?

North America, particularly the United States, accounts for the largest market share for Symproic.

What are the key competitors for Symproic?

Symproic competes with other mu-opioid receptor antagonists such as Methylnaltrexone (Relistor), Naloxegol (Movantik), and Alvimopan (Entereg).

Sources

1. Grand View Research: Opioid Induced Constipation Market Size, Share Report 2030
2. Shionogi Inc.: FY 2017 Financial Results
3. Collegium Pharmaceutical: Investor Presentation
4. ResearchAndMarkets.com: Symproic - Drug Insight, 2019
5. Shionogi Inc.: 1st Half of Fiscal 2017 Financial Results