Generic SUFENTANIL CITRATE INN equivalents, pharmaceutical patent and freedom to operate

Sponsor	Phase
Wu Jieping Medical Foundation	PHASE4
Xiangya Hospital of Central South University	PHASE4
Brugmann University Hospital	Phase 3

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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		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Rising	SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050-001	May 4, 1984	AP	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2612645		⤷ Start Trial
South Korea	20140044949		⤷ Start Trial
Japan	2012509325		⤷ Start Trial
Hong Kong	1204546	用於口腔跨粘膜劑型給藥的存儲和分配裝置 (STORAGE AND DISPENSING DEVICES FOR ADMINSISTRATION OF ORAL TRANSMUCOSAL DOSAGE FORMS)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2114383	300797	Netherlands	⤷ Start Trial	PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 20150922
2114383	122016000023	Germany	⤷ Start Trial	PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	SPC/GB16/004	United Kingdom	⤷ Start Trial	PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383	16C0010	France	⤷ Start Trial	PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Last updated: January 15, 2026

Summary

Sufentanil citrate, a potent synthetic opioid analgesic primarily used in anesthesia, is witnessing evolving market dynamics driven by advances in pain management, regulatory landscapes, and the opioid epidemic. This article analyzes current market trends, key players, regulatory influences, and future financial trajectories, providing comprehensive insights for stakeholders and investors.

What is Sufentanil Citrate?

Sufentanil citrate is a powerful synthetic opioid analgesic, approximately 5-10 times more potent than fentanyl, predominantly utilized in anesthesia during surgical procedures. Its high potency necessitates precise dosing and specialized administration protocols, often limited to hospital settings.

Property	Details
Molecular Formula	C22H30N2O2SCl
Potency	5-10x fentanyl
Primary Use	Surgical anesthesia
Administration	Intravenous, in controlled clinical settings

What Are the Key Market Drivers for Sufentanil Citrate?

Growing Adoption in Anesthesia and Pain Management

Increasing global surgical volume, projected to reach over 1.2 billion procedures annually by 2030 ([1]), fuels demand.
The preference for fast-onset, short-duration analgesics favors sufentanil due to its rapid pharmacokinetics and high efficacy.

Advancements in Anesthetic Techniques

Adoption of minimally invasive surgeries boosts the use of potent opioids like sufentanil.
Enhanced patient safety protocols recommend opioids with predictable pharmacodynamic profiles.

Regulatory and Reimbursement Environment

Approval processes by agencies such as the FDA (United States), EMA (Europe), and other regional bodies facilitate market access.
Reimbursement policies favor anesthetic agents with proven efficacy and safety profiles.

Pandemic Impact and Surgical Resumption

COVID-19 led to delayed elective procedures; a resurgence in surgeries post-pandemic restores demand.

What Are the Challenges and Regulatory Trends Impacting Sufentanil Citrate?

Stringent Opioid Regulations

Rising scrutiny over opioid misuse and diversion impacts availability.
Stringent manufacturing, distribution, and prescription controls in key markets such as the U.S. ("opioid crisis" initiatives) restrict broad utilization.

Synthetic Opioid Crisis and Public Policy

Increased government efforts to limit high-potency opioids’ usage impact market access.
The 2019 U.S. CDC guideline restricts opioid prescriptions for pain, indirectly influencing anesthesia practices where opioids are adjuncts.

Supply Chain and Manufacturing Constraints

Dependence on specialized synthetic routes with complex chemistry increases manufacturing costs.
Geographic concentration of manufacturing facilities enhances supply risk.

Emerging Alternatives and Novel Technologies

Developments in non-opioid analgesics and regional anesthesia techniques threaten traditional opioid reliance.

What Are the Key Competitive Players and Market Segments?

Company	Product(s)	Market Share (Estimated)	Region Focus	Remarks
Johnson & Johnson	Sufentanil (Sufenta)	60% (US & EU)	Global	Leading provider with extensive clinical use
Hikma Pharmaceuticals	Sufentanil	20%	Middle East, Europe	Growing presence with generic options
Other regional players	Various	20%	Asia, Latin America	Focused on hospital formulations

Market Segmentation

Segment	Sub-segments	Key Factors
End-Use	Hospitals, Ambulatory Surgery Centers (ASCs)	Preference for controlled environments
Geography	North America, Europe, Asia-Pacific, Rest of World	Market maturity, regulatory environment, surgical volume
Distribution Channel	Hospital pharmacy, direct procurement	Strict procurement policies

Financial Trajectory and Market Forecast

Historical Growth Trends

Estimated global market size (2022): USD 600 million, with a CAGR of approximately 4.5% from 2018-2022 ([2]).
North America dominates, accounting for roughly 70% of regional sales due to advanced healthcare infrastructure and high surgical volumes.

Projected Growth (2023–2030)

Year	Market Size (USD millions)	CAGR	Key Drivers
2023	630	4.5%	Pandemic recovery, surgical backlog
2025	735	4.8%	Increased adoption, technological advances
2030	960	4.5%	Market maturation, emerging markets

Factors Influencing Future Growth

Market Penetration: Expansion into emerging markets (e.g., China, India).
Regulatory Developments: Favorable approvals for new formulations.
Innovation: Development of alternative analgesics or formulations reducing opioid dependency.
Price & Reimbursement: Cost pressures may influence market share and profitability.

Comparison with Related Opioids

Drug	Potency	Approved Indications	Regulatory Status	Market Penetration
Fentanyl	80-100x morphine	Severe pain, anesthesia	Widely approved; controlled substance	80% of opioid analgesic market ([3])
Remifentanil	Rapid onset/offset	Anesthesia adjunct	Approved globally	Niche but growing
Sufentanil	5-10x fentanyl	Intraoperative analgesia	Approved in select regions	High in specialized settings

Comparison of Market Challenges and Opportunities

Challenge	Opportunity
Rising opioid regulations	Innovation in delivery methods (e.g., controlled-release)
Public health policies limiting opioid overuse	Development of non-opioid analgesics as alternatives
Supply chain complexities	Diversification of manufacturing sites
Competition from novel agents	Strategic alliances and licensing

What Are the Strategic Implications for Stakeholders?

Manufacturers

Invest in R&D to develop safer, targeted formulations.
Expand into emerging markets with tailored regulatory strategies.
Collaborate with health authorities to align on safe prescribing practices.

Investors

Monitor regulatory changes that could impact profitability.
Evaluate companies with diversified opioid portfolios versus narrowly focused ones.
Assess pipeline developments from competitors and new entrants.

Healthcare Providers

Balance efficacy with evolving safety standards.
Adopt protocols minimizing opioid dependency risks.

Key Regulatory Updates Affecting Market Trajectory

Region	Policy/Regulation	Impact	Date
US	CDC Guidelines on Opioids	Restrict high-dose opioid prescribing	2019
EU	EMA Risk Management Plans	Enhanced safety monitoring	Ongoing
Asia-Pacific	Emerging regulatory frameworks	Variable, rapidly evolving	2020–present

Conclusion: The Outlook for Sufentanil Citrate

The market for sufentanil citrate balances its intrinsic clinical value in anesthesia with external pressures from regulation, public health policies, and alternative therapies. Its financial trajectory is cautiously optimistic, with moderate growth anticipated through 2030, driven by surgical volume increases, regional expansion, and technological innovations. However, the evolving regulatory landscape and rising emphasis on opioid stewardship warrant strategic agility from manufacturers and investors alike.

Key Takeaways

Market Size & Growth: Estimated USD 600 million in 2022 with a CAGR of ~4.5%; projected to reach USD 960 million by 2030.
Dominant Players: Johnson & Johnson (Sufenta) holds ~60% market share; regionally strong in North America and Europe.
Growth Drivers: Rising global surgical procedures, advancements in anesthetic technique, and new hospital applications.
Challenges: Stringent regulations, opioid misuse concerns, supply chain complexities, and competition from non-opioid analgesics.
Opportunities: Expansion into emerging markets, formulation innovations, and strategic partnerships.

FAQs

1. How does sufentanil citrate compare to fentanyl in clinical use?
Sufentanil is roughly 5-10 times more potent than fentanyl, offering a rapid onset and short duration ideal for precise intraoperative analgesia. It requires meticulous dosing and monitoring but provides advantages in patient recovery times.

2. What are the primary regulatory hurdles for sufentanil citrate?
Regulatory challenges include strict prescription controls, classification as a Schedule II controlled substance in the US, and global efforts to curb opioid misuse, affecting distribution and usage patterns.

3. Is there a significant market emerging outside North America and Europe?
Yes. Asian markets, especially China and India, are expanding their healthcare infrastructure, opening new opportunities for sufentanil citrate, albeit with regulatory adaptations and local manufacturing considerations.

4. Are there any promising innovations that could disrupt the sufentanil market?
Development of non-opioid analgesics and regional anesthesia techniques, along with sustained-release formulations of current opioids, could shift market dynamics, emphasizing safety and reduced dependency risks.

5. How has the COVID-19 pandemic affected the sufentanil citrate market?
The pandemic caused postponement of elective surgeries, temporarily suppressing demand. As surgical procedures resume, a rebound is expected, supported by increased healthcare spending and technological adaptations.

References

[1] Global Surgical Volume Forecasts, WHO, 2022.
[2] MarketAnalysis.com, "Opioid Analgesics Market Report," 2022.
[3] IQVIA, "Global Opioid Market Data," 2022.

International Patents:	105
US Patents:	21
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sufentanil citrate
What excipients (inactive ingredients) are in sufentanil citrate?	sufentanil citrate excipients list
DailyMed Link:	sufentanil citrate at DailyMed

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Summary for sufentanil citrate

Recent Clinical Trials for sufentanil citrate

Pharmacology for sufentanil citrate

Medical Subject Heading (MeSH) Categories for sufentanil citrate

Anatomical Therapeutic Chemical (ATC) Classes for sufentanil citrate