FENTANYL CITRATE PRESERVATIVE FREE Drug Patent Profile

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Which patents cover Fentanyl Citrate Preservative Free, and when can generic versions of Fentanyl Citrate Preservative Free launch?

Fentanyl Citrate Preservative Free is a drug marketed by Dr Reddys, Fresenius Kabi Usa, and Hospira. and is included in three NDAs.

The generic ingredient in FENTANYL CITRATE PRESERVATIVE FREE is fentanyl citrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fentanyl Citrate Preservative Free

A generic version of FENTANYL CITRATE PRESERVATIVE FREE was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

Summary for FENTANYL CITRATE PRESERVATIVE FREE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	4,606
DailyMed Link:	FENTANYL CITRATE PRESERVATIVE FREE at DailyMed

Pharmacology for FENTANYL CITRATE PRESERVATIVE FREE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL CITRATE PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	074917-001	Feb 3, 1998		DISCN	No	No
Fresenius Kabi Usa	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	210762-001	May 3, 2019	AP	RX	No	No
Hospira	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	072786-001	Sep 24, 1991		DISCN	No	No

Fentanyl Citrate Preservative-Free Market Dynamics, Patent Position, and Financial Trajectory

Last updated: October 15, 2026

Fentanyl citrate preservative-free injection is a mature, generic sterile injectable market with low product-level pricing, limited patent barriers, and demand concentrated in hospitals, ambulatory surgery centers, emergency departments, and anesthesia practice. Its financial performance is driven less by innovation or exclusivity than by manufacturing reliability, controlled-substance compliance, institutional contracts, procurement concentration, and periodic shortage conditions.

The product has no biosimilar exposure because fentanyl citrate is a small-molecule drug. Generic entry has already occurred. The principal commercial risks are price compression, supply disruption, regulatory controls, and substitution by other injectable opioids or non-opioid anesthesia products.

What is fentanyl citrate preservative-free injection?

Fentanyl citrate preservative-free injection is a sterile injectable opioid analgesic used for analgesia and as an adjunct to general and regional anesthesia. It is supplied in single-dose vials, ampules, and other injectable presentations without antimicrobial preservatives.

Common labeled strengths include:

Strength	Typical concentration
Fentanyl citrate injection	50 mcg/mL
2 mL presentation	100 mcg fentanyl base equivalent, depending on labeling convention
5 mL presentation	250 mcg fentanyl base equivalent
10 mL presentation	500 mcg fentanyl base equivalent

Product labeling generally emphasizes respiratory depression, chest wall rigidity, bradycardia, medication error risk, and dependence liability. Fentanyl citrate injection is administered by trained clinicians in settings equipped for airway management and opioid reversal (U.S. Food and Drug Administration [FDA], 2023a).

The preservative-free formulation is important for parenteral use where benzyl alcohol or other antimicrobial preservatives may be unsuitable. The product is distinct from transdermal fentanyl systems, buccal fentanyl products, nasal formulations, and illicitly manufactured fentanyl.

What is the FDA regulatory status of fentanyl citrate preservative-free?

Fentanyl citrate injection is an FDA-approved prescription controlled substance. Injectable products are approved through original new drug applications or abbreviated new drug applications, depending on the manufacturer and product history.

Key regulatory characteristics include:

Regulatory factor	Market implication
FDA classification	Prescription opioid analgesic and anesthetic adjunct
Controlled substance	Schedule II under the Controlled Substances Act
Approval pathway	NDA and ANDA products
Product type	Sterile injectable, generally single-dose and preservative-free
Biosimilar pathway	Not applicable
REMS exposure	Opioid class controls and institutional compliance requirements
Distribution	Hospital, surgical, emergency, and specialty-care channels

FDA product records and labeling establish the approved use, strength, route of administration, warnings, and storage requirements. The legal market is distinct from illicit fentanyl, which is manufactured and distributed outside the approved pharmaceutical supply chain (FDA, 2023a; Drug Enforcement Administration, 2024).

What patents protect fentanyl citrate preservative-free injection?

The core fentanyl molecule and fentanyl citrate injectable technology are mature. The original composition and basic use patents expired many years ago. No active composition-of-matter patent is expected to block generic manufacture of standard fentanyl citrate injection.

Patent category	Current commercial relevance
Fentanyl composition patents	Expired
Fentanyl citrate salt claims	Expired or commercially ineffective as a barrier
Basic injectable-use claims	Expired
Standard vial or ampule presentation	Generally unprotected by enforceable exclusivity
Manufacturing-process patents	Potentially relevant only if narrow, active, and product-specific
Packaging and device patents	Limited relevance to standard injectable vials
Method-of-use patents	Low relevance for routine anesthesia and analgesia use

The practical intellectual-property position is therefore weak for the standard preservative-free injectable product. A manufacturer could still hold confidential manufacturing know-how, validated aseptic-processing procedures, supplier agreements, or narrow process claims. Those assets may affect operational replication without creating a meaningful market monopoly.

What is the Orange Book status of fentanyl citrate injection?

Fentanyl citrate injection is a genericized product category. Orange Book relevance depends on the specific reference-listed drug, dosage form, strength, and approved application.

For a standard injectable generic, the principal commercial conclusion is that no meaningful remaining brand exclusivity protects the active ingredient or routine preservative-free presentation. Any application-specific patent listing would need to be reviewed against the relevant FDA application and product entry rather than inferred from the molecule alone (FDA, 2024a).

The market has the characteristics of an off-patent injectable category:

• Multiple approved or historically approved suppliers.
• No meaningful data exclusivity for the mature active ingredient.
• No biosimilar approval process.
• Low likelihood that a new Paragraph IV filing would materially alter market structure.
• Greater importance of manufacturing approval, supply continuity, and controlled-substance quotas than patent enforcement.

When did fentanyl citrate lose exclusivity?

Fentanyl citrate lost practical exclusivity decades ago. The original innovator product, Sublimaze, was commercialized in the 1960s. Standard injectable fentanyl has since become a generic hospital product.

The commercial timeline is:

Period	Market event
1960s	Fentanyl introduced as a clinical anesthetic and analgesic
1970s to 1990s	Expansion across anesthesia and hospital pain-management settings
Later generic era	Multiple manufacturers entered injectable fentanyl
2010s	Heightened opioid regulation and supply-chain scrutiny
2020s	Continued hospital demand, with periodic sterile-injectable shortages and procurement pressure

Patent expiration dates for individual historical patents vary by filing and jurisdiction, but they do not create a current blocking estate for conventional fentanyl citrate injection.

How many patents cover preservative-free fentanyl citrate?

No reliable commercial analysis should count historical fentanyl patents as current market barriers. The relevant distinction is between patents that once covered fentanyl or its uses and patents that remain enforceable and commercially applicable to today’s preservative-free injectable products.

For standard fentanyl citrate injection, the effective barrier count is generally zero at the active-ingredient level. A manufacturer may have unrelated patents involving:

• Container-closure systems.
• Syringe or premixed-bag delivery.
• Stability-enhancing packaging.
• Automated compounding systems.
• Specialized formulations.
• Manufacturing or purification processes.

These claims would not normally prevent competition in ordinary preservative-free vials or ampules unless they were both valid and necessary to reproduce the marketed product.

How strong is the patent estate for fentanyl citrate preservative-free?

The patent estate is weak. Product value depends on regulatory execution rather than patent exclusivity.

The strongest defensible assets are operational:

1. FDA-approved sterile manufacturing capacity.
2. Controlled-substance registration and quota management.
3. Validated aseptic processing.
4. Reliable access to fentanyl active pharmaceutical ingredient.
5. Hospital formulary and group purchasing organization contracts.
6. A record of uninterrupted supply.
7. Packaging and labeling systems that reduce medication errors.

These assets can create practical switching costs, but they are not equivalent to patent protection. A new entrant with adequate regulatory approval and manufacturing capacity could compete on the same active ingredient and standard dosage forms.

What drives the market for fentanyl citrate injection?

Hospital procedure volume is the primary demand driver. Demand is linked to:

• General surgery.
• Cardiac and thoracic procedures.
• Emergency medicine.
• Intensive care.
• Interventional radiology.
• Obstetric anesthesia.
• Ambulatory surgery.
• Postoperative analgesia.

Demand is relatively stable compared with newer specialty pharmaceuticals because fentanyl injection is embedded in clinical protocols. However, volume can shift toward remifentanil, hydromorphone, morphine, sufentanil, ketamine, dexmedetomidine, and non-opioid multimodal analgesia.

The product also faces policy pressure. Hospitals monitor opioid use, medication diversion, respiratory events, and prescribing appropriateness. These controls reduce discretionary use but have less effect on anesthetic applications where fentanyl remains a standard option.

What is the financial trajectory for fentanyl citrate preservative-free?

Product-level revenue is generally not reported separately by manufacturers. Public-company filings typically aggregate injectable products within broader hospital, generic, or sterile-injectable portfolios. The financial trajectory is therefore best assessed through market structure rather than a standalone branded-sales series.

Financial driver	Expected effect
Generic competition	Long-term price erosion
Hospital contracting	Lower net prices and higher volume requirements
Sterile manufacturing scarcity	Temporary pricing leverage during shortages
Controlled-substance compliance	Higher fixed operating costs
Supply interruptions	Volume loss, customer penalties, and reputational damage
Stable procedure demand	Supports recurring baseline volume
Opioid stewardship	Gradual pressure on discretionary use
Manufacturing consolidation	Higher exposure to single-site failures

The base-case financial profile is a low-margin, recurring-volume product. Revenue growth is unlikely to come from price increases. It is more likely to result from market-share gains, new hospital contracts, shortage-related volume, or additional dosage forms.

Margins can improve when a supplier has excess sterile capacity, strong purchasing relationships, and a reliable supply record. Margins deteriorate when multiple suppliers compete aggressively or when a manufacturer must absorb higher costs for quality remediation, controlled-substance security, raw materials, or regulatory compliance.

Which companies compete in the fentanyl citrate injection market?

Competition varies by country and changes as approvals, supply agreements, and product discontinuations change. The U.S. market has historically included major generic and hospital-product suppliers such as Pfizer subsidiary Hospira, Hikma Pharmaceuticals, Fresenius Kabi, and other approved generic manufacturers.

The relevant competitive dimensions are:

• Current FDA approval and active commercial supply.
• Strength of sterile injectable manufacturing network.
• Institutional contracting reach.
• Controlled-substance handling infrastructure.
• Product availability in multiple vial sizes.
• Shortage history.
• Ability to transfer production between sites.

Manufacturer presence should be assessed through current FDA approval records, NDC listings, wholesaler availability, and shortage databases rather than historical label records alone (FDA, 2024a; FDA, 2024b).

What patent litigation and Paragraph IV challenges affect fentanyl citrate?

There is no central patent dispute expected to define the standard fentanyl citrate preservative-free injection market. The product is too mature and genericized for a conventional Paragraph IV campaign to create substantial value unless a sponsor introduces a differentiated formulation, delivery device, or new indication.

Potential disputes would more likely concern:

• A novel long-acting formulation.
• A premixed or ready-to-administer presentation.
• A delivery device.
• Abuse-deterrent technology.
• A manufacturing process.
• A new therapeutic indication.

Routine injectable fentanyl is not an attractive target for patent litigation because the core product lacks meaningful exclusivity and the economic upside is limited.

What generic entry risks exist?

Generic entry is already established, so the risk is not a future first generic launch. The commercial risk is continuing price erosion from additional suppliers and contract rebidding.

The most important scenario is a multi-supplier market with stable demand and declining net prices. A second scenario involves a manufacturing disruption at one or more major suppliers. In that case, remaining suppliers may gain volume and temporary pricing power, but regulators and hospitals may respond by qualifying alternative sources.

A third scenario involves substitution. Expanded use of multimodal analgesia, regional anesthesia, and alternative sedative agents could reduce fentanyl injection volume over time. This risk is gradual rather than abrupt.

How does fentanyl citrate compare with other injectable opioids?

Product	Patent position	Main competitive use	Commercial profile
Fentanyl citrate injection	Mature generic	Anesthesia and acute analgesia	High clinical familiarity, price pressure
Morphine injection	Mature generic	Acute pain, emergency care	Broad substitution potential
Hydromorphone injection	Mature generic	Severe pain	Higher unit economics in some settings
Sufentanil injection	Mature generic or limited supplier market	Anesthesia and intensive care	Smaller volume, higher potency
Remifentanil injection	Mature generic	Short procedures and anesthesia	Competes where rapid offset matters
Ketamine injection	Mature generic	Anesthesia, analgesia, sedation	Non-opioid substitute in selected settings

Fentanyl retains an advantage in potency, rapid onset, and extensive anesthesia familiarity. Its disadvantages include respiratory-depression risk, diversion controls, and increasing institutional scrutiny.

What is the geographic coverage of the market?

The United States is a major market because of its large hospital system, high surgical volume, controlled-substance regulation, and recurring sterile-injectable shortages. Europe, Canada, Japan, and other regulated markets also use fentanyl citrate injection, but product names, approved strengths, procurement systems, and reimbursement structures differ.

Global commercial success depends on country-specific approvals, controlled-substance import permits, local manufacturing or distribution arrangements, and hospital tender access. A U.S. ANDA does not provide automatic market access elsewhere.

Key Takeaways

• Fentanyl citrate preservative-free injection is a mature, off-patent sterile injectable.
• Core composition and routine-use patents no longer provide meaningful market exclusivity.
• Biosimilar risk is irrelevant because fentanyl citrate is a small molecule.
• Paragraph IV litigation is unlikely to materially affect standard injectable fentanyl.
• Revenue is driven by hospital procedure volume, contracts, availability, and manufacturing reliability.
• Long-term pricing is pressured by generic competition and institutional procurement.
• Shortages can temporarily improve supplier pricing and volume but increase regulatory and reputational risk.
• The strongest commercial assets are sterile manufacturing capacity, supply continuity, controlled-substance compliance, and hospital distribution.
• Substitution by morphine, hydromorphone, remifentanil, ketamine, dexmedetomidine, and multimodal analgesia is a gradual competitive risk.
• The product’s financial profile is recurring but low-growth, with upside concentrated in market share and supply reliability rather than innovation.

Frequently Asked Questions

Is fentanyl citrate preservative-free a branded drug?

No. The standard injectable product is primarily supplied as a generic hospital drug, although branded and legacy reference products may appear in historical regulatory records.

Does fentanyl citrate injection have remaining market exclusivity?

No meaningful product-level exclusivity is expected for the standard preservative-free injectable presentation. The active ingredient and routine clinical uses are mature.

Can a generic manufacturer launch fentanyl citrate injection without a patent risk?

Patent risk is generally low for standard vials and ampules. The principal requirements are FDA approval, controlled-substance compliance, validated sterile manufacturing, and reliable supply.

Does fentanyl citrate injection have biosimilar competition?

No. Biosimilars apply to biologic products. Fentanyl citrate is a chemically synthesized small molecule and competes through generic-drug pathways.

What would improve the financial outlook for a fentanyl citrate manufacturer?

The strongest opportunities are hospital contract wins, shortage-driven share gains, expanded vial or syringe presentations, production-cost reduction, and reliable multi-site sterile manufacturing.

References

1. Drug Enforcement Administration. (2024). Drug scheduling and controlled substances. U.S. Department of Justice. https://www.dea.gov/drug-information/drug-scheduling

2. U.S. Food and Drug Administration. (2023a). Fentanyl citrate injection prescribing information. https://www.accessdata.fda.gov

3. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

4. U.S. Food and Drug Administration. (2024b). Drug shortages. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

5. U.S. Food and Drug Administration. (2024c). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/