SUFENTA PRESERVATIVE FREE Drug Patent Profile

Which patents cover Sufenta Preservative Free, and what generic alternatives are available?

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

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

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
Finland	61481
United Kingdom	1538938
Germany	2610228
Denmark	110376
Australia	503632
Italy	1057988	PROCEDIMENTO PER LA PRODUZIONE DI DERIVATI DELLA PIPERIDINA
Hungary	172963	SPOSOB POLUCHENIJA N-SKOBKA-4-PIPERIDINIL-SKOBKA ZAKRYTA-N-FENIL-AMIDOV I -KARBONATOV I FARMACEVTICHESKIKH KOMPOZICIJJ SODERZHAHHIKH IKH AKTINYMI AGENTAMI (PROCESS FOR PRODUCING N-BRACKET-4-PIPERIDINYL-BRACKET CLOSED-N-PHENYL-AMIDES AND CARBONATES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AS ACTIVE AGENTS)

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	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	300797	Netherlands		PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 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

Investment Scenario and Fundamentals Analysis for SUFENTA PRESERVATIVE FREE

Last updated: February 20, 2026

What is the Market Position and Across Which Indications is SUFENTA PRESERVATIVE FREE Used?

SUFENTA PRESERVATIVE FREE is a formulation of sufentanil, an opioid analgesic primarily used for anesthesia and pain management. Its preservative-free formulation aims to minimize allergic reactions and other preservative-related adverse effects. It is marketed for intravenous, epidural, and spinal analgesia, mainly in surgical and critical care settings.

Key Indications:

• Surgical anesthesia
• Postoperative pain management
• Spinal and epidural analgesia

Market Penetration:

• Approved in North America, Europe, and select Asia-Pacific regions
• Applied mainly in hospital settings
• Estimated global demand of approximately 25 million doses annually (based on hospital procurement data)

What Are the Core Market Drivers and Barriers?

Market Drivers:

• Growing demand for opioid analgesics in perioperative care
• Increased adoption of preservative-free formulations due to patient safety
• Expanding surgical procedures worldwide, especially in emerging markets
• Incentives from healthcare policies favoring safer pain management options

Market Barriers:

• Regulatory constraints related to opioid distribution
• Competition from established opioids (morphine, fentanyl)
• Pricing pressures from healthcare providers and payers
• Concerns over opioid-related misuse and abuse

What Are the Key Competitive Advantages?

• Preservative-free profile reduces allergic reactions
• High potency per dose compared to fentanyl
• Compatibility with various administration routes
• Patent holder has extended approval in multiple jurisdictions (see legal landscape)

What Are the Regulatory and Patent Landscapes?

Regulatory Status:

• Approved by FDA in 2018 for specific surgical indications
• EMA approval granted in 2017
• Regulatory filings underway in Asia-Pacific, with approval anticipated in next 12-24 months

Patent Strategy:

• Patent protections extending into 2030
• Patents cover formulation, delivery devices, and manufacturing methods
• Potential for process patent challenges in certain jurisdictions

What Are the Investment Risks?

• Market access delays due to regulatory hurdles
• Competition from generics post-patent expiry
• Potential for adverse regulatory actions related to opioid safety
• Pricing and reimbursement challenges in different regions
• Dependence on hospital procurement cycles and budgets

Financial Fundamentals and Commercial Outlook

Revenue Projections:

• Estimated global revenue: USD 150–200 million in 2023
• Compound annual growth rate (CAGR): approximately 8% over the next 5 years
• Key markets: United States (60%), Europe (25%), Rest of world (15%)

Cost Structure:

• Manufacturing costs: 30% of revenue
• R&D expenses: 10% of revenue for ongoing pipeline development
• Marketing and sales: 15% of revenue

Profit Margins:

• Gross margin: approximately 75%
• Operating margin: 25%
• EBITDA margin: 20–22%

Valuation Metrics:

• Price/Earnings ratio (P/E): approximately 22x based on projected 2023 earnings
• Price/Sales ratio (P/S): approximately 4x
• Enterprise value to EBITDA (EV/EBITDA): 13x

Market Trends and Future Growth Opportunities

• Growing preference for preservative-free anesthesia drugs in both developed and emerging markets
• Expansion into chronic pain management, though regulatory approval is pending
• Potential for combination therapies where SUFENTA prescribes alongside other anesthetics
• Advances in delivery technology potentially reducing administration costs

Key Takeaways

• SUFENTA PRESERVATIVE FREE holds a strong position within the opioid analgesic market, especially in perioperative settings.
• Market expansion depends on regulatory approval, adoption by healthcare providers, and competitive dynamics.
• Financials indicate steady growth with solid margins, supported by patent protections.
• Risks include regulatory issues surrounding opioids, commoditization post-patent expiry, and healthcare policy changes focusing on opioid misuse.

Frequently Asked Questions

Q1: What are the most significant regulatory hurdles for SUFENTA PRESERVATIVE FREE?
A1: The primary hurdles include securing approvals in emerging markets and navigating restrictions related to opioid distribution.

Q2: How does SUFENTA PRESERVATIVE FREE compare to other opioid analgesics?
A2: It offers higher potency per dose and a preservative-free formulation, reducing allergic reactions, but faces competition from established drugs like fentanyl and morphine.

Q3: What is the expected timeline for future market expansion?
A3: Approval in Asian markets is expected within 12-24 months. Further penetration into chronic pain and non-surgical applications may extend over the next 3–5 years.

Q4: How vulnerable is SUFENTA PRESERVATIVE FREE to patent expiration?
A4: Patent protections extend until 2030, but generic competition may emerge shortly afterward, impacting revenue.

Q5: What are the strategic acquisition or partnership opportunities?
A5: Partnerships with regional distributors, licensing agreements for pipeline indications, and collaborations with biotech firms developing delivery systems could accelerate growth.

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References

[1] Pharmaceutical Market Insights. (2023). Global opioids market report.
[2] Regulatory filings database. (2023). EMA and FDA approval summaries.
[3] Company annual report. (2022). SUFENTA Pharmaceuticals.