SUFENTANIL CITRATE - Generic Drug Details

What are the generic sources for sufentanil citrate and what is the scope of freedom to operate?

Sufentanil citrate is the generic ingredient in three branded drugs marketed by Rising, Hikma, Hospira, Watson Labs, and Vertical Pharms, and is included in five NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has one hundred and five patent family members in twenty countries.

There are five drug master file entries for sufentanil citrate. Three suppliers are listed for this compound.

Summary for SUFENTANIL CITRATE

International Patents:	105
US Patents:	21
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	7
Patent Applications:	1,102
What excipients (inactive ingredients) are in SUFENTANIL CITRATE?	SUFENTANIL CITRATE excipients list
DailyMed Link:	SUFENTANIL CITRATE at DailyMed

Recent Clinical Trials for SUFENTANIL CITRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Brugmann University Hospital	Phase 3
Jiangang Song	N/A
West China Hospital	Phase 4

See all SUFENTANIL CITRATE clinical trials

Pharmacology for SUFENTANIL CITRATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for SUFENTANIL CITRATE

Adjuvants, Anesthesia

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for SUFENTANIL CITRATE

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for SUFENTANIL CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	11,672,738		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	8,778,394
Watson Labs	SUFENTANIL CITRATE	sufentanil citrate	INJECTABLE;INJECTION	074406-001	Dec 15, 1995		DISCN	No	No
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	10,342,762		Y

Expired US Patents for SUFENTANIL CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050-001	May 4, 1984	3,998,834

International Patents for SUFENTANIL CITRATE

Country	Patent Number	Title	Estimated Expiration
Spain	2784486
China	101378732	Bioadhesive drug formulations for oral transmucosal delivery
Austria	E474564
World Intellectual Property Organization (WIPO)	2007081947

Supplementary Protection Certificates for SUFENTANIL CITRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2114383	122016000023	Germany		PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	16C0010	France		PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	300797	Netherlands		PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 20150922
2114383	CR 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922

SUFENTANIL CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sufentanil Citrate

Market Overview

Sufentanil citrate, a potent opioid analgesic and analogue of fentanyl, is widely used in medical settings for pain management, surgical anesthesia, and intensive care. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global sufentanil citrate market has been experiencing significant growth. As of 2023, the market size was valued at USD 200 million and is projected to reach USD 328.37 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7% from 2024 to 2031[3].

Key Drivers of Market Growth

Increasing Demand for Pain Management

The rising prevalence of chronic pain and the increasing number of surgical procedures globally are major drivers of the sufentanil citrate market. Chronic non-malignant and cancer pain management are key areas where sufentanil citrate is extensively used[2][3].

Technological Advancements

Advancements in anesthetic techniques and novel drug delivery systems have enhanced the efficacy and safety of sufentanil citrate. These developments have led to increased adoption in clinical settings[3].

Growing Elderly Population

The elderly population, which is more prone to ailments requiring pain treatment, is another significant factor driving the market. This demographic shift ensures a steady demand for potent analgesics like sufentanil citrate[3].

Healthcare Spending and Reimbursement Policies

Rising healthcare expenditures and favorable reimbursement policies in emerging markets have facilitated wider availability and application of sufentanil citrate. This has particularly boosted the market in regions like Asia-Pacific[1][3].

Market Segmentation

By Type

The sufentanil citrate market is segmented into injectable, transdermal patches, and sublingual tablets. Each form has its specific applications and user base, contributing to the overall market growth[3].

By Application

The primary applications include pain management, surgical anesthesia, intensive care, and emergency medicine. Sufentanil citrate is particularly valued for its use in epidural and surgical analgesia due to its potent analgesic properties[2][3].

Geographical Regions

North America currently leads the market, followed by Europe and Asia-Pacific. However, the Asia-Pacific region is expected to experience the fastest growth due to rapidly developing medical infrastructure, increasing medical tourism, and higher spending on healthcare in countries like China and India[1].

Regional Market Analysis

North America

This region dominates the market due to advanced healthcare infrastructure, higher awareness among physicians about advanced treatments, and significant spending on research and development by pharmaceutical companies[1].

Europe

Europe is the second-largest market for sufentanil citrate, driven by similar factors as North America, including high healthcare spending and advanced medical facilities[1].

Asia-Pacific

The Asia-Pacific region is projected to have the fastest growth, driven by the rapid development of medical infrastructure, increasing medical tourism, and growing awareness among the population in developing nations[1].

Market Challenges and Restraints

Regulatory Hurdles

The use of sufentanil citrate is heavily regulated due to its potent opioid nature. Regulatory approvals and compliance with stringent safety standards can act as barriers to market entry for new players[2].

Competition and Substitutes

The market faces competition from other opioid analgesics and potential substitutes. The threat of new entrants and the degree of competition are significant factors that influence market dynamics[1].

Adverse Effects

Sufentanil citrate can cause significant side effects such as respiratory depression, muscle rigidity, and fetal harm, which can impact its adoption and usage[4].

Financial Projections

Revenue and Volume Forecast

The market is expected to see substantial growth in both revenue and volume. By 2031, the revenue is forecasted to reach USD 328.37 million, with a significant increase in the number of units sold[3].

Pricing Analysis

The pricing of sufentanil citrate is influenced by various factors including production costs, regulatory environment, and market competition. The report includes detailed pricing analysis to help stakeholders understand the financial dynamics[1].

Value Chain Analysis

The value chain analysis of the sufentanil citrate market includes supplier analysis, distributor analysis, and trend analysis. This helps in understanding the entire supply chain from raw material sourcing to end-user delivery[1].

Opportunities and Trends

Multimodal Pain Management

The increasing use of multimodal pain management techniques is a significant trend that supports market expansion. Sufentanil citrate is often used in combination with other medications to enhance pain relief[3].

Technological Innovations

Advancements in medication delivery systems, such as advanced isolated robotic equipment and other aseptic processing technologies, are driving the market forward. These innovations ensure higher sterility and quality of the drug[2].

Key Takeaways

• Market Growth: The sufentanil citrate market is expected to grow at a CAGR of 7% from 2024 to 2031.
• Key Drivers: Increasing demand for pain management, technological advancements, growing elderly population, and favorable healthcare spending and reimbursement policies.
• Market Segmentation: By type (injectable, transdermal patches, sublingual tablets) and application (pain management, surgical anesthesia, intensive care).
• Regional Dynamics: North America leads, followed by Europe and Asia-Pacific, with the latter expected to grow the fastest.
• Challenges: Regulatory hurdles, competition, and adverse effects.

FAQs

What are the primary applications of sufentanil citrate?

Sufentanil citrate is primarily used for pain management, surgical anesthesia, intensive care, and emergency medicine, particularly for epidural and surgical analgesia[2][3].

Which region is expected to experience the fastest growth in the sufentanil citrate market?

The Asia-Pacific region is projected to have the fastest growth due to rapidly developing medical infrastructure and increasing medical tourism[1].

What are the major side effects of sufentanil citrate?

Major side effects include respiratory depression, muscle rigidity, and fetal harm. It can also cause sedation and respiratory depression in infants exposed through breast milk[4].

How does the market segmentation of sufentanil citrate help in understanding its growth?

Market segmentation by type (injectable, transdermal patches, sublingual tablets) and application (pain management, surgical anesthesia, etc.) helps in identifying specific growth areas and user bases[3].

What role do technological advancements play in the sufentanil citrate market?

Technological advancements in anesthetic techniques and novel drug delivery systems enhance the efficacy and safety of sufentanil citrate, driving its adoption and market growth[3].

Sources

1. IndustryARC: Sufentanil Citrate Market - Forecast(2024 - 2030)[1]
2. University of Maryland, Baltimore: Sufentanil citrate - Summary Report[2]
3. Market Research Intellect: Global Sufentanil Citrate Market Size and Projections[3]
4. DrugBank Online: Sufentanil: Uses, Interactions, Mechanism of Action[4]