SUFENTANIL CITRATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	SUFENTANIL CITRATE	sufentanil citrate	INJECTABLE;INJECTION	074534	ANDA	Hospira, Inc.	0409-3382-21	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-21) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11)	2005-07-26
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128	NDA	AcelRx Pharmaceuticals, Inc.	61621-430-01	1 TABLET in 1 POUCH (61621-430-01)	2018-11-02
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128	NDA	AcelRx Pharmaceuticals, Inc.	61621-430-11	10 TABLET in 1 CARTON (61621-430-11)	2018-11-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 24, 2026

What suppliers provide sufentanil citrate API, finished dosage forms, and distribution services?

Suppliers for sufentanil citrate typically split into four buckets: (1) API manufacturers, (2) finished-dose manufacturers (often proprietary injectable products), (3) contract manufacturers for sterile injectable production, and (4) specialty distributors that can handle controlled-substance logistics and cold-chain/sterile requirements where applicable.

Sourcing reality for sufentanil citrate: sufentanil is a Schedule II controlled opioid in the US (controlled-substance classification applies to the substance and marketed dosage forms). This concentrates supply among licensed sterile injectable manufacturers and specialty distribution networks rather than broad OTC-style pharmaceutical wholesalers.

API supply chain: who can realistically supply sufentanil citrate API?

In practice, API supply is dominated by a limited group of qualified manufacturers that maintain:

GMP production for controlled opioids and tight impurity controls
validated containment, cross-contamination control, and controlled substance security
DMF/EDMF support for cross-reference and regulatory readiness (US and EU)

Common procurement pattern: finished-dose manufacturers qualify one or two API sources and then qualify a backup source for continuity. For global procurement, many customers use CMOs and brokers to manage regulatory documents and controlled-substance compliance.

Finished-dose supply: who manufactures marketed sufentanil citrate injections?

Most sufentanil citrate market supply is concentrated in companies that produce sterile injectable opioids under FDA-approved ANDAs or NDAs (or hold marketed RLD/brand rights). These suppliers are the most relevant counterparties for hospitals, surgery centers, anesthesia groups, and pharmacy buyers because they deliver through established controlled-substance distribution lanes.

Specialty distribution suppliers: who distributes sufentanil citrate?

Sufentanil citrate distribution is typically handled by:

national specialty pharma distributors
regional controlled-substance wholesalers with anesthesia/hospital customer access
direct-to-provider logistics from the manufacturer for constrained supply periods

These distributors focus on:

controlled-substance licensing alignment
inventory forecasting to prevent diversion and stock-outs
remittance traceability and chain-of-custody documentation

Contract manufacturing (CMO) for sterile injectables

CMOs supply sterile drug product manufacturing under QMS and validated aseptic processes. For sufentanil citrate specifically, CMOs must also support controlled-substance handling. This narrows the pool to sterile-focused facilities with prior opioid experience.

Which companies supply sufentanil citrate injection in the US and what are the Orange Book and FDA status implications?

Featured-snippet answer: The practical “supplier list” for US market use is the set of FDA-approved holders/distributors marketing sufentanil citrate injections, because procurement for hospitals and group purchasing organizations typically sources finished dosage forms, not raw API.

How to map “supplier” to FDA status

For controlled opioids, buyers should treat:

FDA label holder as the primary supplier for assured supply and labeling compliance
ANDA holders as the competitive supplier set once generics are approved
distributors as fulfillment channels, not IP holders

If the drug is listed as the “reference listed drug” (RLD), the FDA listing drives the authoritative view of who can market a particular strength, package, and route. Sourcing decisions should align to FDA product label and NDC/label strength.

Orange Book status: what it determines for sourcing decisions

Orange Book listings matter for:

IP-driven exclusivity or patent blocking for generic supply
risk of supply disruption around exclusivity expiration or authorized generics
litigation and settlement outcomes that can affect launch timing

For controlled opioids, manufacturing slots can also be constrained. So even if patents permit entry, practical ability to ship on time depends on sterile injectable capacity and controlled-substance logistics.

When do sufentanil citrate patents and exclusivity expire and how does that change supplier availability?

Featured-snippet answer: Patent and exclusivity timelines determine when additional FDA-approved suppliers can enter as authorized generics or ANDA products, which then expands the supplier set for distributors and group purchasing.

Typical timeline mechanics that drive supplier shifts

Composition of matter and process patents usually anchor early exclusivity
Formulation and specific container/packaging patents can extend barriers for certain package/strength presentations
Method-of-use patents are less common as barrier drivers for sterile opioid injections, but can affect some labeled claims

Generic entry risks that affect supplier count

Even when legal barriers clear, supply can lag due to:

validation of aseptic manufacturing batches and sterility assurance
procurement and qualification of controlled-opioid API
regulatory filings for specific NDCs and packaging configurations
controlled-substance distribution contracts

What Paragraph IV challenges exist for sufentanil citrate and who is likely to be affected?

Featured-snippet answer: Paragraph IV challenges are relevant only to the set of patent-protected FDA-listed products for sufentanil citrate injections. Where patent challenges occur, they can accelerate generic entry or trigger settlement agreements that temporarily maintain supply under fewer suppliers.

For a supplier strategy, the key is whether:

the market has only one or two active finished-dose suppliers
additional ANDA entrants are locked out by active patents
a settlement triggers “at-risk” timing for non-participating manufacturers

What formulations of sufentanil citrate are supplied and which delivery forms change supplier options?

Featured-snippet answer: Supplier options vary primarily by strength, container type, and packaging configuration for sufentanil citrate injection.

Key formulation parameters procurement teams use

Concentration (mg/mL) and volume per vial
Sterile presentation and container closure system
Unit-of-use vs bulk packaging for hospital dispensing workflows
Labeling for specific anesthesia indications and dosing regimens
Compatibility with common anesthesia admixture workflows (where manufacturers provide guidance)

Why packaging and concentration matter for sourcing

Even if API is interchangeable, FDA-approved product strength, container, and label language can block interchangeability. Controlled opioids are also subject to strict handling, so switching among NDCs without operational readiness can create administrative and clinical friction.

How strong is the patent estate for sufentanil citrate and what does that mean for licensing and supplier switching?

Featured-snippet answer: The patent estate strength determines whether supplier switching is primarily “regulatory feasible” (FDA approval) versus “commercially feasible” (manufacturing and distribution readiness).

Licensing pathways that expand supply

When patent protection limits competition, supply can expand through:

voluntary licensing to additional sterile injectables manufacturers
authorized generics
contract manufacturing agreements where an authorized label holder expands capacity with a CMO

Commercial impact

If the patent estate is tight, supplier count stays low and distributors prioritize stability of allocations. If the estate is permissive, supplier switching becomes more common, and procurement leverage improves.

Which generic and biosimilar strategies affect sufentanil citrate sourcing?

Featured-snippet answer: Biosimilars are not the relevant category for sufentanil citrate since it is a small-molecule opioid. The competitive strategy is generics and authorized generics for finished injectables.

What drives generic approvals for opioid injections

bioequivalence for the finished sterile injectable product
GMP sterility assurance and opioid containment
impurity profile alignment for the API and drug substance release
matching labeling strengths and NDC/packaging configurations

At-risk launch dynamics

In constrained specialty markets, some generic suppliers launch as quickly as FDA clearance permits while others wait until they secure qualified API supply and stable sterile injectable throughput.

What manufacturing and IP barriers commonly constrain new suppliers of sufentanil citrate?

Featured-snippet answer: The bottlenecks are usually sterile injectable capacity, controlled-opioid API sourcing and qualification, and regulatory documentation for specific NDC presentations.

Operational constraints

validated aseptic manufacturing and sterility assurance
cross-contamination control for high-potency opioids
secure controlled-substance storage and chain-of-custody
batch release testing for content uniformity and impurity limits
qualified packaging components that maintain closure integrity

IP constraints

process patents on manufacturing steps
formulation or packaging patents tied to a specific container/closure
trade secret controls that limit process replication even when composition patents expire

Key Takeaways

“Suppliers for sufentanil citrate” should be mapped to FDA-listed finished-dose product holders for practical procurement, with specialty distributors handling controlled-substance logistics.
API supply is constrained to GMP-qualified controlled-opioid manufacturers; qualified backups matter for supply continuity.
The patent estate and exclusivity status control how quickly additional finished-dose suppliers can enter, which drives distributor allocation and pricing leverage.
Formulation differences by strength, vial volume, and packaging can limit interchangeability even when API is the same.
The core barriers for new entrants are sterile injectable capacity, controlled-substance compliance, API qualification, and regulatory readiness for specific NDC/label configurations.

FAQs

What NDCs correspond to sufentanil citrate injection in the US, and who supplies each NDC?
Can distributors source sufentanil citrate API, or is sourcing limited to licensed finished-dose manufacturers?
What constraints most often cause shortages for sufentanil citrate injectable products?
How do patent listings in the Orange Book affect which generic manufacturers can ship sufentanil citrate injections?
What information do hospitals typically require to switch between sufentanil citrate NDCs safely?

References

FDA. “Drugs@FDA.” U.S. Food and Drug Administration. (Database).
FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration. (Database).
DEA. “Controlled Substances.” Drug Enforcement Administration. (Regulatory guidance and schedules).

Suppliers and packagers for generic pharmaceutical drug: SUFENTANIL CITRATE