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. Two 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

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
U.S.S.R.	1227109	"CПOCOБ ПOЛУЧEHИЯ ПPOИЗBOДHЫX ПИПEPИДИHA ИЛИ ИX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX COЛEЙ" (METHOD OF PRODUCING PIPERIDINE DERIVATIVES OR THEIR PHARMACEUTICALLY ACCEPTABLE SALTS)
South Africa	7601528
Finland	61481
Poland	102474
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	122016000023	Germany		PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; 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	16C0010	France		PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	CA 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922

Market Dynamics and Financial Trajectory for SUFENTA Preservative-Free

Last updated: January 26, 2026

Executive Summary

Sufenta Preservative-Free (Sufenta PF), a potent opioid analgesic formulation, has carved its niche within pain management, particularly in surgical and chronic pain settings. This analysis explores the current market environment, competitive landscape, regulatory framework, growth drivers, and revenue projections. Emphasizing preservative-free formulations, the paper underscores how Sufenta PF’s unique positioning influences its market trajectory.

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1. Product Overview and Market Positioning

Attribute	Details
Active Ingredient	Sufentanil (synthetic opioid)
Formulation	Preservative-free injectable solution
Indications	Anesthesia, postoperative pain, chronic pain management
Unique Selling Point	Preservative-free formulation reduces risk of local tissue reactions

Note: Sufenta PF is marketed as a high-potency, fast-acting opioid with lower doses required compared to alternatives, aligning with current opioid prescribing trends emphasizing safety and preservative-free formulations.

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2. Regulatory Landscape

Regulatory Authority	Relevant Policies	Approvals & Milestones
FDA (U.S.)	New Drug Application (NDA) approval, strict opioid scheduling	Approved for anesthesia and pain relief, scheduled under DEA Class II
EMA (Europe)	Marketing Authorization for surgical analgesia	Approved across multiple European countries, within centralized regulatory framework
Other Countries	Varying approval processes, adherence to WHO guidelines	Limited regional approvals, approval dependent on local safety evaluations

Implication: Regulatory approval stability and adherence impact market expansion. With increasing emphasis on preservative-free formulations, approval processes tend to favor drugs with better safety profiles.

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3. Market Dynamics

A. Key Drivers

Driver	Impact & Explanation	Source/Trend
Growing Pain Management Need	Aging populations and chronic disease prevalence escalate demand for potent analgesics	WHO reports (2021), aging demographics globally
Preference for Preservative-Free Formulations	Reduced adverse tissue reactions, enhanced safety profile	Industry shift towards preservative-free injectables (IQVIA, 2022)
Surgical Procedures Volume Increase	Rising surgeries worldwide, especially minimally invasive techniques	Global Surgery Market Data (2022), CAGR: ~5%
Regulatory Trends Favoring Safer Opioids	Pressure to reduce preservative-related adverse effects	FDA and EMA guidelines (2021), patient safety focus

B. Market Restraints

Restraint	Impact & Explanation	Source/Trend
Opioid Regulatory Restrictions	Tightening controls, risk of abuse, and stringent scheduling limit accessibility	DEA, EMA policies (2022), opioid epidemic responses (CDC, 2022)
Market Saturation and Competition	Existing opioids like fentanyl, sufentanil, remifentanil dominate the anesthesia segment	Market reports (Frost & Sullivan, 2021)
Manufacturing Complexity & Costs	Preservative-free formulations require advanced manufacturing, increasing costs	Industry analysis (IQVIA, 2022)

C. Competitive Landscape

Competitors	Formulations	Differentiators	Market Share (Est.)
Fentanyl	Multiple formulations, preservative-containing	Widely used, well-established, versatile formulations	~50%
Remifentanil	Preservative-free, ultra-short acting	Rapid onset/offset, used in critical care	~20%
Other Sufentanil Brands	Preservative-containing formulations	Generic availability, lower price points	~10%
Sufenta PF (Brand)	Preservative-free, high-potency	Safety focus, niche high-acuity use	Estimated ~10%

Note: Market control is fragmented with key opioid leaders, and preservative-free formulations like Sufenta PF are gaining traction due to safety profile enhancements.

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4. Financial Trajectory Analysis

A. Revenue Projections (Global Market)

Year	Estimated Global Sales ($ Millions)	Growth Rate	Assumptions
2023	200	-	Launch period, limited penetration
2024	260	30%	Growing acceptance, expanding indications
2025	338	30%	Increased hospital adoption, new markets entering
2026	440	30%	Broader regional approvals, formulary inclusion
2027	572	30%	Expanded surgical procedures, safety preferences

B. Revenue Drivers

• Market Penetration Rate: Estimated at 15% initially, increasing to 35% over five years.
• Pricing: Average price per dose estimated at $50–$75, higher in specialized hospital settings due to preservative-free advantage.
• Use Cases: Postoperative analgesia (60%), anesthesia adjunct (30%), chronic pain (10%).

C. Cost Factors

Cost Aspect	Estimated % of Revenue	Notes
Manufacturing & R&D	25%	Advanced sterile processing, high-quality standards
Regulatory & Compliance	10%	Clinical trials, approval submissions
Sales & Marketing	15%	Medical education, clinician outreach
Distribution & Logistics	5%	Global logistics, cold-chain requirements
Profit Margin	30–35%	Given premium pricing and safety profile

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5. Comparative Analysis: Key Market Segments and Trends

Segment	Sufenta PF Positioning	Market Share (Estimated)	Growth Potential
In-hospital anesthesia	High due to safety & preservative-free benefits	~10%	High, driven by safety-conscious policies
Postoperative pain	Growing, especially in minimally invasive surgeries	~12%	High, as opioid-sparing approaches gain favor
Chronic pain management	Niche, cautious growth due to regulation	~8%	Moderate, limited by opioid prescription restrictions

Key Market Trends

• Increasing demand for preservative-free opioids driven by safety concerns.
• Shift towards opioid-sparing multimodal analgesia.
• Adoption of targeted pain management protocols.

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6. Deep Dive: Regional Market Opportunities

Region	Market Size (USD)	Key Factors	Challenges
North America	$100M+	High opioid utilization, advanced healthcare systems	Regulatory hurdles, opioid abuse concerns
Europe	$60M+	Aging population, evolving safety policies	Price competition, approval processes
Asia-Pacific	$30M+	Growing surgical volume, cost-sensitive markets	Limited regulatory alignment, manufacturing costs
Latin America	$10–20M	Emerging healthcare infrastructure	Limited awareness, regulatory variability

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7. Policy and Market Access Impacts

• Pricing Policies: Push towards value-based pricing for safer opioid formulations.
• Reimbursement Dynamics: Increasing reimbursements for preservative-free therapies due to reduced adverse events.
• Pharmacovigilance: Ongoing monitoring may influence formulary inclusion timelines.

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8. Comparative Summary Table

Aspect	Sufenta PF	Competitors	Market Position
Formulation Type	Preservative-free injectable	Preservative-containing/less safety targeted	Niche but expanding due to safety profile
Potency	High (sufentanil)	Similar (fentanyl, remifentanil)	Competitive with high safety advantages
Pricing	Premium	Competitive, with generics available	Higher due to preservative-free formulation
Regulatory Approval	Established in major markets	Varies, some established, some generic	Advantage in early approvals for safety-sensitive markets

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Key Takeaways

• Market growth for preservative-free opioids like Sufenta PF is primarily driven by safety concerns, with an expected CAGR of approximately 30% over the next five years.
• Regional expansion opportunities are significant in Europe and Asia-Pacific, with regulatory approval and healthcare infrastructure development being key enablers.
• Pricing strategies should reflect the premium nature of preservative-free formulations, balanced against competitive pressures and reimbursement policies.
• Regulatory trends favor safer opioid formulations, especially amid ongoing efforts to curb opioid misuse while ensuring effective pain management.
• Manufacturing costs are higher, necessitating optimized production processes to sustain margins.

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FAQs

Q1: What factors influence the adoption rate of Sufenta Preservative-Free?
Factors include regulatory approval status, clinician awareness, safety profile advantages, reimbursement policies, and institutional formularies. Adoption accelerates as safety awareness increases and guidelines favor preservative-free options.

Q2: How does the regulatory landscape affect its market trajectory?
Stringent regulations, particularly around opioids, may delay approvals but can also serve as barriers to entry for competitors, positioning Sufenta PF as a safer alternative in approved regions.

Q3: What market segments are most promising for Sufenta PF implementation?
Postoperative pain management and anesthesia during surgeries currently represent the most promising segments, driven by safety benefits and escalating surgical procedures worldwide.

Q4: How does the competition from generic opioids impact Sufenta PF's pricing and market share?
Generic opioids benefit from existing infrastructure and lower prices but lack preservative-free benefits. Sufenta PF's premium pricing and safety profile aim to secure a niche amidst price-sensitive markets.

Q5: What are the primary growth opportunities in emerging markets?
Emerging markets exhibit increasing surgical volumes, expanding hospital infrastructure, and rising safety awareness, creating opportunities for early adoption of preservative-free opioids like Sufenta PF.

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References

[1] WHO Global Health Estimates, 2021.
[2] IQVIA Industry Reports, 2022.
[3] Frost & Sullivan, 2021.
[4] CDC Opioid Prescribing Guidelines, 2022.
[5] European Medicines Agency (EMA), 2022.