SUFENTA PRESERVATIVE FREE Drug Patent Profile

When do Sufenta Preservative Free patents expire, and when can generic versions of Sufenta Preservative Free launch?

Sufenta Preservative Free is a drug marketed by Rising and is included in one NDA.

The generic ingredient in SUFENTA PRESERVATIVE FREE is sufentanil citrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sufenta Preservative Free

A generic version of SUFENTA PRESERVATIVE FREE was approved as sufentanil citrate by HIKMA on December 15^th, 1995.

Summary for SUFENTA PRESERVATIVE FREE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	31
Patent Applications:	747
DailyMed Link:	SUFENTA PRESERVATIVE FREE at DailyMed

US Patents and Regulatory Information for SUFENTA PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050-001	May 4, 1984	AP	RX	Yes	Yes

Expired US Patents for SUFENTA PRESERVATIVE FREE

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

International Patents for SUFENTA PRESERVATIVE FREE

See the table below for patents covering SUFENTA PRESERVATIVE FREE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	148960
Australia	503632
Denmark	110376
Israel	49204	N-(4-PIPERIDINYL)-N-PHENYLAMIDES AND-CARBAMATES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Luxembourg	74511
U.S.S.R.	1227109	"CПOCOБ ПOЛУЧEHИЯ ПPOИЗBOДHЫX ПИПEPИДИHA ИЛИ ИX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX COЛEЙ" (METHOD OF PRODUCING PIPERIDINE DERIVATIVES OR THEIR PHARMACEUTICALLY ACCEPTABLE SALTS)

Supplementary Protection Certificates for SUFENTA PRESERVATIVE FREE

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
2114383	SPC/GB16/004	United Kingdom		PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383	CA 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922

SUFENTA PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sufentanil Citrate (Sufenta Preservative Free)

Introduction

Sufentanil citrate, marketed as Sufenta Preservative Free, is a potent opioid analgesic widely used in anesthesia. Its unique pharmacological profile, including rapid onset and strong analgesic effects, makes it a valuable asset in the anesthesiology market.

Market Demand and Growth

The demand for sufentanil citrate is driven by several factors, including its efficacy in various surgical procedures, particularly in open-heart surgery and major operations involving patients with severe cardiovascular compromise[2].

• Increasing Research and Publications: There has been a notable increase in research publications on sufentanil use in anesthesiology, indicating growing interest and a mature level of research in this field. This trend suggests a strong foundation for its continued use and potential expansion into new clinical applications[3].

Competitive Landscape

Sufentanil citrate competes in a market dominated by other opioid analgesics, but it has several distinct advantages:

• Potency and Efficacy: Sufentanil is significantly more potent than fentanyl, with some studies indicating it is 5 to 10 times more potent. This higher potency allows for lower doses, which can reduce the risk of adverse effects[1][2].

• Pharmacokinetics: Sufentanil has a rapid onset of action and shorter duration compared to fentanyl. It also exhibits better hemodynamic stability and sufficient myocardial oxygen supply, making it preferable in certain clinical scenarios[1][3].

Clinical Applications and Market Segments

Sufentanil citrate is used in various clinical settings:

• General Anesthesia: It is a key component in balanced general anesthesia, providing deep levels of anesthesia without significant cardiovascular depression[1][2].

• Epidural Administration: Sufentanil can be administered epidurally, offering effective analgesia comparable to other opioids like bupivacaine, with favorable outcomes for neonates[1].

• Sublingual Tablets: Products like Dzuveo, which use sufentanil in sublingual tablets, have shown superior analgesia in surgical patients and ease of use for healthcare professionals[4].

Financial Performance and Revenue Streams

The financial trajectory of sufentanil citrate is influenced by several factors:

• Sales and Revenue: Given its high potency and specific clinical applications, sufentanil citrate commands a premium price. This can result in significant revenue, particularly in high-stakes surgical procedures where its benefits are most pronounced[2].

• Clinical Trials and Research Funding: Ongoing research and clinical trials contribute to the financial health of the drug. Funding from pharmaceutical companies, grants, and institutional support helps in further developing and marketing the drug[3].

• Market Expansion: The drug's use in new clinical settings, such as tumor treatment, where it has shown potential in inhibiting cancer cell proliferation, could open new revenue streams[3].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of sufentanil citrate:

• Approval and Licensing: Sufentanil citrate is approved for use in various regions, including the EU and the US. Compliance with regulatory requirements and maintaining approvals is essential for continued market presence[1][4].

• Safety and Efficacy Standards: Regulatory bodies closely monitor the safety and efficacy of sufentanil citrate. Adherence to these standards is critical for maintaining market trust and avoiding financial setbacks due to safety concerns[1][4].

Adverse Effects and Risk Management

While sufentanil citrate offers several advantages, it also comes with potential risks:

• Respiratory Depression and Muscle Rigidity: Common adverse effects include respiratory depression and skeletal muscle rigidity. Effective management of these risks is crucial for maintaining patient safety and avoiding legal or financial repercussions[1][2].

• Hemodynamic Stability: Despite its benefits in maintaining hemodynamic stability, careful monitoring is necessary to manage potential cardiovascular effects, especially in vulnerable patient populations[1][3].

Patient and Healthcare Professional Acceptance

The acceptance of sufentanil citrate by both patients and healthcare professionals is high due to its efficacy and ease of use:

• Clinical Outcomes: Studies have shown that sufentanil citrate provides superior analgesia with fewer adverse effects compared to traditional opioids. This leads to higher patient satisfaction and better clinical outcomes[4].

• Healthcare Professional Feedback: The ease of use and effectiveness of sufentanil citrate have been positively received by healthcare professionals, which can drive continued adoption and recommendation[4].

Future Prospects and Trends

The future of sufentanil citrate looks promising with several trends and prospects:

• Expanding Clinical Applications: Ongoing research into new uses, such as tumor treatment, could expand its market reach and revenue potential[3].

• Technological Advancements: Improvements in drug delivery systems, such as sublingual tablets, can enhance patient compliance and healthcare professional acceptance[4].

• Global Cooperation and Funding: Enhanced cooperation among researchers, institutions, and countries, along with expanded funding support, is expected to further solidify sufentanil citrate's position in the market[3].

Key Takeaways

• High Potency and Efficacy: Sufentanil citrate is significantly more potent than fentanyl, with a rapid onset and shorter duration.
• Clinical Applications: It is used in general anesthesia, epidural administration, and sublingual tablets.
• Financial Performance: The drug commands a premium price due to its specific clinical benefits.
• Regulatory Compliance: Adherence to safety and efficacy standards is crucial.
• Future Prospects: Expanding clinical applications and technological advancements are expected to drive growth.

Frequently Asked Questions (FAQs)

Q1: How potent is sufentanil citrate compared to fentanyl?

• Sufentanil citrate is approximately 5 to 10 times more potent than fentanyl[1][2].

Q2: What are the common adverse effects of sufentanil citrate?

• Common adverse effects include respiratory depression and skeletal muscle rigidity[1][2].

Q3: In which clinical settings is sufentanil citrate most commonly used?

• It is commonly used in general anesthesia, particularly for open-heart surgery and major operations involving patients with severe cardiovascular compromise[1][2].

Q4: How does the pharmacokinetics of sufentanil citrate compare to fentanyl?

• Sufentanil citrate has a rapid onset of action and shorter duration compared to fentanyl, with better hemodynamic stability[1][3].

Q5: Are there any new clinical applications being explored for sufentanil citrate?

• Yes, recent studies have explored its potential in tumor treatment by inhibiting cancer cell proliferation[3].

Cited Sources

1. Sufentanil Citrate Injection, USP CII - accessdata.fda.gov
2. Sufentanil citrate: a new opioid analgesic for use in anesthesia - PubMed
3. Global research on sufentanil use in anesthesiology from 2003 to 2024 - Frontiers in Pharmacology
4. Dzuveo, INN-sufentanil citrate - European Medicines Agency