Sufentanil citrate - Generic Drug Details

What are the generic drug sources for sufentanil citrate and what is the scope of patent protection?

Sufentanil citrate is the generic ingredient in three branded drugs marketed by Rising, Hikma, Hospira, Watson Labs, and Vertical Pharms, and is included in five NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has one hundred and five patent family members in twenty countries.

There are five drug master file entries for sufentanil citrate. Two suppliers are listed for this compound.

Summary for sufentanil citrate

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 Applications:	1,463
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

Recent Clinical Trials for sufentanil citrate

Identify potential brand extensions & 505(b)(2) entrants

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

See all sufentanil citrate clinical trials

Pharmacology for sufentanil citrate

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for sufentanil citrate

Adjuvants, Anesthesia

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for sufentanil citrate

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for sufentanil citrate

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	8,778,394
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	11,672,738		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	11,676,691		Y
Watson Labs	SUFENTANIL CITRATE	sufentanil citrate	INJECTABLE;INJECTION	074406-001	Dec 15, 1995		DISCN	No	No
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	10,245,228		Y
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	9,320,710
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		DISCN	Yes	No	10,896,751		Y

Expired US Patents for sufentanil citrate

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 sufentanil citrate

Country	Patent Number	Title	Estimated Expiration
Austria	E474564
Canada	2636088	FORMES POSOLOGIQUES TRANSMUCOSALES DE PETIT VOLUME (SMALL-VOLUME ORAL TRANSMUCOSAL DOSAGE FORMS)
Canada	2636115	DISPOSITIFS DE DISTRIBUTION ET DE STOCKAGE DE MEDICAMENTS ET SYSTEMES COMPRENANT CEUX-CI (DRUG STORAGE AND DISPENSING DEVICES AND SYSTEMS COMPRISING THE SAME)
Canada	2636119	FORMULATIONS DE MEDICAMENTS BIOADHESIFS POUR ADMINISTRATION PAR VOIE TRANSMUCOSALE ORALE (BIOADHESIVE DRUG FORMULATIONS FOR ORAL TRANSMUCOSAL DELIVERY)
Canada	2673837	DISPOSITIFS DE STOCKAGE ET DE DISTRIBUTION POUR L'ADMINISTRATION DE FORMES DOSIFIEES TRANS-MUQUEUSES ORALES (STORAGE AND DISPENSING DEVICES FOR ADMINISTRATION OF ORAL TRANSMUCOSAL DOSAGE FORMS)
Canada	2673856	FORMES DOSIFIEES DE PETIT VOLUME DE MEDICAMENT CONTENANT DU SUFENTANIL S'ADMINISTRANT PAR VOIE TRANS-MUQUEUSE ORALE POUR LE TRAITEMENT DE LA DOULEUR (SMALL VOLUME ORAL TRANSMUCOSAL DOSAGE FORMS CONTAINING SUFENTANIL FOR TREATMENT OF PAIN)
Canada	2673880	DISPOSITIFS DE STOCKAGE ET DE DISTRIBUTION DESTINES A L'ADMINISTRATION DE FORMES PHARMACEUTIQUES TRANSMUCOSIQUES ORALES (STORAGE AND DISPENSING DEVICES FOR ADMINSISTRATION OF ORAL TRANSMUCOSAL DOSAGE FORMS)

Supplementary Protection Certificates for sufentanil citrate

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

SUFENTANIL CITRATE Market Dynamics and Financial Trajectory (US and Global)

Last updated: July 10, 2026

Executive summary: Su fentanil citrate is a niche, high-acuity opioid anesthesia and analgesia drug with tightly constrained supply, limited formulary breadth, and concentrated usage in perioperative and procedural settings. Financial trajectory is driven more by hospital purchasing cycles, payer and formulary access in the US, and competitive intensity from alternative opioids and adjunct anesthetic regimens than by broad outpatient demand. In the absence of robust publicly reported transaction-level financials for specific supplier SKUs, market dynamics are best characterized through regulatory status, controlled-substance governance, competitive product positioning (including generic and non-generic opioid competitors), and litigation and exclusivity timelines affecting supply and pricing.

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SUFENTANIL CITRATE market size drivers: what controls demand and pricing?

Direct answer: Demand is concentrated in surgical and procedural anesthesia workflows, with pricing and volume constrained by (1) controlled-substance distribution controls, (2) hospital procurement formularies, (3) opioid stewardship and anesthesia protocol selection, and (4) supply reliability.

What hospital use patterns drive SUFENTANIL CITRATE volume?

Su fentanil citrate is typically used in anesthesia for analgesia and to support general anesthesia. Volume is driven by:

• Procedure volume and case mix (elective vs emergent surgeries).
• Anesthesiology practice standards (dose selection and choice of opioid).
• Institutional preference tied to standard order sets and conversion from legacy opioids.
• Product conversion events such as switchovers from branded to generic supply, if available.

How do controlled-substance rules affect commercialization?

Su fentanil is a highly regulated opioid (controlled under US federal and state frameworks). Operational impacts on pricing and growth include:

• Higher compliance and inventory management costs for wholesalers and hospitals.
• Contracting friction for new entrants (distribution agreements, training, and monitoring).
• Greater sensitivity to supply disruptions (lead time and allocation dynamics).

What payer and formulary mechanics shape financial outcomes?

Even in inpatient-heavy use, financial trajectory depends on:

• Hospital formulary inclusion for perioperative opioids.
• Contract pricing structures and group purchasing organization (GPO) tenders.
• Coverage through medical benefit pathways (not a typical pharmacy benefit growth curve).

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What competitive landscape affects SUFENTANIL CITRATE revenue: which opioid anesthetics compete?

Direct answer: Competition is primarily intraclass anesthesia opioids and alternative anesthetic regimens, where clinicians select based on onset, potency equivalence, hemodynamic effects, and protocol preference.

How do clinicians substitute if supply or price changes?

Substitution risk exists via:

• Alternative opioids used for analgesia and anesthesia induction or maintenance.
• Multimodal anesthesia protocols that reduce opioid dose intensity.
• Institutional rotation rules that periodically re-bid anesthetic drug contracts.

Where SUFENTANIL CITRATE is most defensible

Su fentanil’s defensibility tends to be strongest where:

• Pharmacy and therapeutics committees already have entrenched conversion pathways and dosing familiarity.
• Preferred drug lists include it for certain surgical categories.
• Contract pricing makes it cost-competitive against alternatives.

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SUFENTANIL CITRATE exclusivity and patent estate: what patents protect it and when do they expire?

Direct answer: A complete, enforceable patent-and-exclusivity map for SUFENTANIL CITRATE must be built from Orange Book listings and patent databases tied to each specific FDA application and dosage form. Without those application-level identifiers and patent lists, a precise expiration timeline and strength assessment cannot be produced accurately.

(No further patent timeline content is provided to avoid fabricating dates or counts.)

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What is the Orange Book status of SUFENTANIL CITRATE?

Direct answer: Orange Book status is application-specific and requires the exact FDA product listing(s) for SUFENTANIL CITRATE (strength, dosage form, and NDA/ANDA identifiers). Without those identifiers, an accurate Orange Book summary cannot be provided.

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Does SUFENTANIL CITRATE face generic or biosimilar entry risks under Paragraph IV?

Direct answer: Paragraph IV risk applies to ANDA products for small molecules and is driven by the existence and timing of FDA-listed patents for the relevant NDA. A reliable Paragraph IV analysis requires the specific Orange Book patent listings for the SUFENTANIL CITRATE product(s) in question. That cannot be produced from the provided prompt.

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Formulation and manufacturing: what technical/IP barriers affect SUFENTANIL CITRATE supply and margins?

Direct answer: Margins are constrained by controlled-substance handling, sterile manufacturing quality systems (if applicable), batch release testing, and limited sourcing capacity.

What manufacturing constraints can limit supply expansion?

For perioperative injectable opioids, supply is typically constrained by:

• Sterile manufacturing capacity and contamination control.
• Batch release specifications and stability validation.
• Distribution compliance and secure chain-of-custody requirements.

How do supply constraints transmit into pricing?

Where supply is tight:

• Hospital contracts can reprice at renewal or during shortages.
• Allocation can shift buyers toward available SKUs, reducing competitive price pressure in the short term.

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When does SUFENTANIL CITRATE lose exclusivity and how does that affect pricing?

Direct answer: The effect of exclusivity expiration is predictable in structure but cannot be timed precisely without the specific FDA application, listed patents, and exclusivity codes. In general, loss of exclusivity increases competitive entry risk, which tends to:

• Compress unit prices at contract renewal.
• Increase procurement leverage for large hospital systems.
• Shift volume to the lowest total cost-of-ownership supplier.

(No date-specific statement is included.)

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SUFENTANIL CITRATE FDA regulatory status: what pathways matter for financial trajectory?

Direct answer: Financial trajectory is driven by whether products are marketed under approved NDAs and whether any ANDA transitions are underway for specific dosage forms/strengths.

What regulatory events typically move the business

• Label updates affecting dosing protocols.
• Shortage reporting and supply notifications.
• Approval of generic equivalents and subsequent contract renegotiations.
• Litigation-linked stays that delay entry.

(Product-level event details require FDA application identification.)

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What patent litigation affects SUFENTANIL CITRATE commercial timing?

Direct answer: Patent litigation impact depends on the presence of FDA-listed patents and the existence of ANDA-related litigation. A credible litigation map requires case captions, court docket details, and the relevant NDA/ANDA relationships.

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US vs global dynamics: where is SUFENTANIL CITRATE adoption strongest and why?

Direct answer: Adoption tracks surgery volume and anesthesia capacity, with constraints from opioid regulation and procurement systems. Regions with higher procedural intensity and established hospital procurement infrastructure generally exhibit stronger utilization.

How regulations shape global growth

• Controlled substance scheduling and import/export controls.
• Local tender systems and hospital formulary cycles.
• Availability of substitute anesthetic opioids.

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Revenue trajectory scenarios for SUFENTANIL CITRATE: base, bull, bear drivers

Direct answer: For niche hospital opioids, revenue trajectory is typically less about new patient acquisition and more about contract outcomes, supply reliability, and competitive positioning.

Base-case drivers

• Stable surgical volumes.
• Continued formulary inclusion through GPO and health-system contracts.
• Pricing tracks contract renewal and inflation-linked adjustments.

Bull-case drivers

• Reduced competition due to delayed generic entry or constrained supply from limited manufacturers.
• Favorable contracting that preserves higher net prices.
• Improved supply reliability that secures conversion to preferred stock.

Bear-case drivers

• Generic or competitive substitution increases at contract renewal.
• Shorter supply cycles for branded supply create substitution into cheaper alternatives.
• Increased downward pressure from opioid stewardship protocols that shift dosing practices.

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Key Takeaways

• SUFENTANIL CITRATE demand is anchored in inpatient perioperative anesthesia use, with volume sensitive to surgical case mix rather than outpatient adoption.
• Pricing power is limited by controlled-substance economics, hospital contracting leverage, and substitution among opioid anesthetics and multimodal regimens.
• A precise financial and exclusivity timeline requires product-level FDA application identifiers and Orange Book patent lists; without them, any claim of patent expirations, litigation, or entry timing cannot be made accurately.
• The most actionable commercial levers are supply reliability, contract strategy with large hospital systems and GPOs, and monitoring competitive substitution points at contract renewals.

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FAQs

1. How does opioid stewardship affect perioperative SUFENTANIL CITRATE utilization?
2. What pricing mechanics apply to hospital opioids like SUFENTANIL CITRATE in GPO contracts?
3. How do shortage events for injectable controlled opioids change hospital purchasing behavior?
4. What competitive substitution patterns occur between SUFENTANIL and other anesthetic opioids?
5. What regulatory and distribution constraints most impact commercialization of highly controlled opioid injectables?

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References

(No sources were provided in the prompt, and no reliable, citable product-level FDA/Orange Book, litigation, or financial datasets can be cited without introducing non-provided identifiers.)