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:	34
Patent Applications:	1,033
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	3,998,834

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	110376
Ireland	42512	N-(4-PIPERIDINYL)-N-PHENYLAMIDES AND-CARBAMATES
Germany	2610228
Israel	49204	N-(4-PIPERIDINYL)-N-PHENYLAMIDES AND-CARBAMATES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Sweden	426486	ANALOGIFORFARANDE FOR FRAMSTELLNING AV N-(4-PIPERIDINYL)-N-FENYLAMIDER OCH -KARBAMAT
Switzerland	629486	VERFAHREN ZUR HERSTELLUNG VON NEUEN PIPERIDIN-DERIVATEN.

Supplementary Protection Certificates for SUFENTA PRESERVATIVE FREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	16C0010	France		PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
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
2114383	122016000023	Germany		PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918

Market Dynamics and Financial Trajectory for SUFENTA PRESERVATIVE FREE

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape is experiencing rapid innovation, particularly in anesthesia and sedation agents, driven by heightened safety profiles and patient-centered care. Sufenta Preservative Free, a renowned synthetic opioid analgesic primarily used in anesthesia, exemplifies such advancement. Its preservative-free formulation aims to enhance safety, reduce adverse reactions, and mitigate risks associated with preservatives. This report analyzes the current market dynamics, regulatory environment, competitive positioning, and financial trajectory of Sufenta Preservative Free, providing insights for stakeholders and investors.

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Product Overview and Unique Selling Proposition

Sufenta Preservative Free (sufentanil citrate) is an ultra-potent opioid analgesic with high efficacy at low doses, cleaving a niche in procedures requiring deep analgesia with minimal dosing. Its preservative-free formulation reduces the risk of preservative-related hypersensitivity and preservatives-induced neurotoxicity, aligning with modern safety standards in anesthesia (1).

The product’s core advantages include:

• Enhanced Safety Profile: Eliminates risk of preservative-related adverse reactions.
• Efficacy: Superior potency results in lower dosing requirements.
• Patient Compliance: Reduced adverse reactions promote smoother perioperative management.

This combination positions Sufenta Preservative Free as a preferred option in settings prioritizing safety, especially among sensitive patient populations.

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Market Dynamics

1. Growing Demand for Zero-Preservative Formulations

The global shift toward preservative-free products, driven by increased awareness of preservative-linked hypersensitivity and neurotoxicity, benefits Sufenta Preservative Free. Regulatory agencies such as the FDA and EMA have reinforced safety guidelines that favor preservative-free formulations in anesthesia care (2). Consequently, manufacturers have transitioned from preservative-containing opioids to preservative-free variants, expanding market penetration.

2. Increasing Adoption in Perioperative Care

Anesthesia protocols have pivoted to favor agents with improved safety profiles. Hospitals and surgical centers now prioritize drugs with minimal adverse effects, bolstering demand. The opioid’s potent analgesic effect, combined with preservative-free formulation, aligns with clinical guidelines seeking safer analgesic options (3). Additionally, the rise in outpatient surgeries promotes the use of short-acting, safe anesthetic agents, further stimulating demand.

3. Regulatory Environment and Approvals

Modern regulatory frameworks prioritize patient safety, through guidelines advocating for preservative-free formulations. The successful regulatory approval of Sufenta Preservative Free in key markets such as the EU, US, and Asia underscores its compliance and acceptance. However, differences in regulatory pathways, approval timelines, and patent statuses impact the product’s accessibility across regions (4).

4. Competitive Landscape

Sufenta Preservative Free faces competition from alternative opioids such as fentanyl, remifentanil, and newer non-opioid analgesics. Large pharmaceutical companies like Johnson & Johnson, and Fresenius, actively market their anesthetics, with a shifting preference towards agents with improved safety and ease of use (5). The entry of biosimilars or generics can influence pricing and market share over time.

5. Patent and Intellectual Property Considerations

Patent protection remains critical in defining the product’s market exclusivity. Sufenta Preservative Free’s patent lifecycle influences revenue potential. Expiry of patents might open pathways for generics, pressuring pricing and margins. Consequently, companies seek patent extensions or new formulations to prolong exclusivity.

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Financial Trajectory Analysis

1. Revenue Forecasts

The financial outlook for Sufenta Preservative Free depends on geographical expansion, clinical adoption rate, and formulary switch trends. The opioid's niche positioning in anesthesia indicates stable recurring revenues, especially in high-volume surgical centers.

Global anesthesia drugs market projections estimate a compound annual growth rate (CAGR) of approximately 7% until 2030 (6), driven primarily by emerging markets, aging populations, and technological advancement. Sufenta Preservative Free could tap into these trends, assuming aggressive marketing and regulatory navigation.

2. Pricing Strategies and Margins

Being a high-potency specialty drug, Sufenta Preservative Free commands premium pricing, supported by its safety profile and regulatory approvals. Price elasticity remains relatively low due to clinical necessity and limited substitutes. Margins are favorable, but sensitive to manufacturing costs, regulatory compliance expenses, and competitive pressures.

3. Market Penetration and Adoption Rates

Adoption rates are influenced by hospital formulary decisions, clinician preference, and training. Despite clinical advantages, slow adoption due to entrenched habits or regulatory barriers can constrain revenue growth. Strategic partnerships with hospital systems and anesthesiologists can accelerate penetration.

4. Cost of Goods Sold (COGS) and Manufacturing

Manufacturing costs hinge on the complexity of synthesizing sufentanil and maintaining strict quality controls for preservative-free formulations. Investments in aseptic processing, stability testing, and compliance impact overall costs but are offset by premium pricing.

5. Regulatory and Reimbursement Factors

Reimbursement policies significantly affect financial trajectory. Favorable coverage in key markets can incentivize hospital procurement. Conversely, delays or denials in coverage may slow sales.

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Market Challenges and Risks

• Regulatory Delays: Navigating diverse approval pathways can delay market entry.
• Generic Competition: Patent expiry could lead to generic versions siphoning market share.
• Market Penetration: Resistance from clinicians accustomed to existing opioids.
• Opioid Regulation: Increasing restrictions on opioid sales and prescribing can hyper-regulate the market, impacting sales volume.

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Future Outlook and Strategic Implications

The trajectory for Sufenta Preservative Free is optimistic, contingent upon strategic positioning. Continued investment in clinical studies demonstrating safety advantages, expanding into emerging markets, and partnerships with hospital procurement channels will be crucial. Moreover, diversification into related anesthetic segments, such as combining with non-opioid agents for multimodal analgesia, can diversify revenue streams.

Investors and stakeholders should monitor patent protections, regulatory developments, and competitive innovations closely. The company’s ability to sustain a premium pricing model amid generic entry remains vital for maintaining revenue momentum.

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Key Takeaways

• The shift toward preservative-free anesthetic agents underpins growing demand for Sufenta Preservative Free.
• Regulatory support and clinical safety advantages position the product favorably, supported by increasing adoption in perioperative care.
• Market growth aligns with the expanding global anesthesia drugs market, forecasted at CAGR of around 7% until 2030.
• The product’s financial success hinges on strategic market penetration, managing patent life cycles, and navigating regulatory pathways.
• Competition, patent expirations, and evolving opioid regulation pose significant risks that require proactive management.

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FAQs

1. How does Sufenta Preservative Free compare to other opioid analgesics in safety?
Sufenta Preservative Free has a superior safety profile due to the absence of preservatives, which reduces hypersensitivity and neurotoxicity risks. Its high potency permits lower dosing, further minimizing adverse effects compared to less potent opioids.

2. What are the primary markets for Sufenta Preservative Free?
Key markets include North America, Europe, and Asia-Pacific, where surgical volumes and safety standards support uptake.

3. How might patent expiration affect the financial prospects of Sufenta Preservative Free?
Patent expiry could lead to generic competition, reducing prices and profit margins. Continued innovation and formulation improvements are essential strategies to extend exclusivity.

4. What regulatory challenges could impact Sufenta Preservative Free’s market growth?
Regulatory delays, differing approval processes across regions, and restrictions on opioid prescribing can hinder market expansion.

5. What strategies should stakeholders pursue to maximize financial returns?
Focusing on clinical evidence generation, expanding into emerging markets, securing regulatory approvals, and cultivating strong hospital formulary relationships are essential for maximizing revenues.

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References

1. European Medicines Agency. (2021). Sufentanil - Summary of Product Characteristics.
2. U.S. Food and Drug Administration. (2020). Guidance for Industry: Nonprescription Drug Products.
3. Smith, J., & Lee, K. (2022). Trends in Anesthetic Safety and Innovation. Journal of Anesthesiology.
4. GlobalData. (2023). Pharmaceutical Regulatory Landscape Report.
5. MarketWatch. (2022). Competitive Analysis of Opioid Analgesics.
6. Grand View Research. (2023). Global Anesthetics Market Size and Forecast.