FOSPROPOFOL DISODIUM - Generic Drug Details

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What are the generic sources for fospropofol disodium and what is the scope of freedom to operate?

Fospropofol disodium is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for FOSPROPOFOL DISODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	26
DailyMed Link:	FOSPROPOFOL DISODIUM at DailyMed

Recent Clinical Trials for FOSPROPOFOL DISODIUM

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

Sponsor	Phase
Ya-Qun Zhou	PHASE4
Rugao People's Hospital	NA
Hai 'an People's Hospital	NA

See all FOSPROPOFOL DISODIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FOSPROPOFOL DISODIUM

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for FOSPROPOFOL DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008		DISCN	No	No

Expired US Patents for FOSPROPOFOL DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008	6,204,257
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008	6,872,838

Fospropofol Disodium Market Dynamics, Commercial History, and Financial Trajectory

Last updated: September 2, 2026

Fospropofol disodium is a water-soluble prodrug of propofol that received FDA approval in 2008 under the brand name Lusedra. Its commercial trajectory was short: regulatory approval did not translate into a durable market because generic propofol was inexpensive, clinically familiar, and widely available. Eisai discontinued U.S. commercialization after limited uptake, and fospropofol disodium has no meaningful current revenue base or active biosimilar market.

The principal investment conclusion is that fospropofol disodium is a commercially inactive product rather than a growing pharmaceutical asset. Its remaining value is primarily historical, academic, or potentially relevant to reformulation and licensing strategies.

What is fospropofol disodium and what was it approved for?

Fospropofol disodium is a phosphate prodrug that is converted in vivo to propofol. It was developed to improve the aqueous solubility and handling characteristics of propofol, which is supplied as a lipid emulsion.

The FDA approved Lusedra on December 12, 2008, under New Drug Application 022244. The approved indication was monitored anesthesia care sedation in adults undergoing diagnostic or therapeutic procedures. Lusedra was administered intravenously and required dose titration because of risks including respiratory depression, hypoxemia, hypotension, and excessive sedation (U.S. Food and Drug Administration [FDA], 2008).

Attribute	Fospropofol disodium
Active drug relationship	Prodrug of propofol
Original brand	Lusedra
Developer and commercial sponsor	Guilford Pharmaceuticals; later Eisai
FDA approval	December 12, 2008
FDA application	NDA 022244
Initial indication	Monitored anesthesia care sedation in adults
Dosage form	Intravenous injection
Therapeutic class	Sedative-hypnotic anesthetic
Current commercial position	No established active U.S. commercial market

Fospropofol was not a new anesthetic mechanism. Its value proposition depended on formulation and administration advantages rather than superior pharmacology.

When did fospropofol disodium lose commercial exclusivity?

Fospropofol disodium lost commercial viability primarily through market failure rather than a single identifiable patent cliff. The product entered a market dominated by low-cost generic propofol and established procedural sedation protocols.

The commercial sequence was:

Period	Event	Commercial implication
1990s to early 2000s	Development of fospropofol as a water-soluble propofol prodrug	Attempt to differentiate propofol through formulation
2005	Eisai acquired Guilford Pharmaceuticals	Eisai obtained the product and development assets
2008	FDA approved Lusedra	Regulatory entry into procedural sedation
2009 to 2010	Early U.S. commercialization	Adoption remained limited
Around 2010	Eisai discontinued active U.S. commercial activity	Product lost practical market access
2010s onward	Generic propofol and newer sedation options expanded	Fospropofol had no durable commercial recovery

Public company disclosures did not establish a material revenue stream for Lusedra. Eisai’s annual reports treated the product within a broader portfolio and did not report a separate, significant revenue line that would support a reliable product-level sales estimate (Eisai Co., Ltd., 2009, 2010).

What patents protected fospropofol disodium?

The historical intellectual-property estate centered on the prodrug compound, phosphate chemistry, pharmaceutical compositions, and methods of sedation. Those categories are less commercially durable than a broad composition-of-matter patent covering a novel therapeutic class because fospropofol ultimately generates the same active sedative, propofol.

Composition and prodrug patents

The core patent strategy sought to protect water-soluble phosphonooxy derivatives of propofol and related compounds. Patent protection likely included:

• Fospropofol disodium and related phosphate prodrugs.
• Pharmaceutical compositions for intravenous administration.
• Conversion of the prodrug to propofol in vivo.
• Use in procedural sedation and anesthesia.
• Formulations designed to improve aqueous stability and administration.

The relevant U.S. patents were filed many years before FDA approval. Their ordinary patent terms therefore placed expiration in the late 2010s or early 2020s, depending on the specific patent, patent-term adjustment, patent-term extension, and claim scope.

No current, material U.S. blocking patent position is evident from the product’s commercial status and historical FDA records. Any remaining patents would be more likely to cover narrow formulations, manufacturing processes, or specific methods than the general use of fospropofol disodium as an injectable sedative.

Formulation patents

The formulation rationale was central to the product. Conventional propofol is an oil-in-water emulsion that requires controlled handling and carries risks associated with lipid emulsions, contamination, and injection characteristics. Fospropofol was designed as a water-soluble alternative.

Potential formulation protections included:

• Stable aqueous solutions.
• Injectable phosphate salt compositions.
• Concentration and pH ranges.
• Packaging and storage conditions.
• Administration protocols that reduced emulsion-related handling issues.

These protections did not create a durable commercial moat because hospitals could obtain inexpensive generic propofol and did not need to adopt a new formulation solely to avoid an emulsion.

Method-of-use patents

Method-of-use claims could cover:

• Sedation for diagnostic procedures.
• Monitored anesthesia care.
• Procedural sedation in adult patients.
• Dosing and titration protocols.
• Conversion of fospropofol to propofol for controlled sedation.

Method-of-use protection was commercially weaker than broad composition protection because clinicians had numerous alternative sedatives, and hospitals could use propofol under established protocols.

What is the FDA regulatory status of fospropofol disodium?

Fospropofol disodium was FDA approved, but it did not become a sustained commercial product. The historical Lusedra approval is distinct from current product availability.

FDA approval established that fospropofol had an acceptable benefit-risk profile for its approved indication under the labeled conditions. It did not guarantee continued manufacture, distribution, or commercial demand. The product’s withdrawal from commercial supply was associated with business and market conditions rather than a publicly established FDA safety withdrawal.

The product’s regulatory profile has three relevant elements:

1. It entered through the conventional NDA pathway.
2. It was approved for adults receiving monitored anesthesia care.
3. The approval did not generate sufficient commercial demand to support continued U.S. marketing.

The regulatory asset therefore has limited practical value unless a sponsor can demonstrate a new clinical, economic, or delivery advantage.

What was the financial trajectory of Lusedra?

Lusedra’s financial trajectory was characterized by high development and regulatory expenditure followed by weak commercialization.

Development phase

Guilford invested in the development of a differentiated propofol prodrug. Eisai’s acquisition of Guilford in 2005 transferred the product into a larger pharmaceutical infrastructure with global regulatory and commercial resources.

The investment thesis depended on several potential benefits:

• Avoidance of a lipid emulsion.
• Easier intravenous formulation.
• Potentially predictable conversion to propofol.
• Use in outpatient procedures and monitored anesthesia care.
• Differentiation from generic propofol.

Approval phase

FDA approval in 2008 provided a regulatory milestone but did not establish a premium market. Hospitals and ambulatory centers evaluate sedatives on acquisition cost, onset and recovery profile, staff familiarity, adverse-event management, supply reliability, and reimbursement economics.

Fospropofol faced a difficult launch environment because generic propofol was already deeply embedded in anesthesia practice.

Commercial phase

The product had several commercial disadvantages:

• Generic propofol was inexpensive.
• Fospropofol required clinicians to learn a different dosing and titration approach.
• The prodrug did not eliminate the core risks of propofol exposure.
• The product was associated with adverse effects including paresthesia, hypoxemia, and hypotension.
• Hospitals had limited economic incentive to switch from established generic products.
• The indication was narrower than the broader use of propofol across general anesthesia, intensive care, and procedural sedation.

No reliable public source reports a large revenue contribution from Lusedra. Its discontinuation indicates that sales did not justify ongoing commercial investment, although the absence of a separately reported product revenue figure prevents a precise cumulative-loss or return-on-investment calculation.

How does fospropofol compare with competing sedatives?

Fospropofol competed against products with stronger clinical familiarity, lower cost, or more differentiated pharmacology.

Product	Main advantage	Main limitation versus fospropofol
Generic propofol	Low cost, extensive clinical experience, broad use	Lipid-emulsion formulation
Midazolam	Familiar benzodiazepine sedation	Slower and less predictable recovery in some settings
Dexmedetomidine	Sedation with limited respiratory depression relative to some alternatives	Bradycardia, hypotension, slower onset, higher cost
Remifentanil	Rapidly titratable opioid analgesia	Respiratory depression and opioid-related risks
Remimazolam	Rapid offset and newer procedural-sedation profile	Newer-market pricing and adoption barriers
Fospropofol	Water-soluble prodrug formulation	Limited adoption, adverse effects, weak economic differentiation

Fospropofol’s principal competitor was not another patented prodrug. It was generic propofol. That distinction materially weakened its pricing power.

Which companies challenged fospropofol disodium?

No significant current Paragraph IV challenge market is associated with fospropofol disodium. The product’s commercial decline occurred without the type of generic-entry contest seen with high-revenue products that remain actively marketed.

The likely competitive pressure came from:

• Generic propofol manufacturers.
• Established anesthesia suppliers.
• Alternative sedative manufacturers.
• Hospital formulary committees.
• Procedural sedation protocols favoring existing products.

Because fospropofol was a small-molecule drug, biosimilar competition was not applicable. Any follow-on product would proceed through an abbreviated generic pathway or a separate 505(b)(2) application, depending on the formulation and clinical differences.

What generic entry risks exist for fospropofol disodium?

Generic entry risk is technically straightforward but commercially limited. A manufacturer could potentially develop an abbreviated product if it could satisfy requirements for pharmaceutical equivalence, quality, stability, and bioequivalence. The main barriers would be:

• Demonstrating equivalence for an intravenous prodrug.
• Reproducing the formulation and concentration.
• Establishing manufacturing controls.
• Obtaining adequate commercial scale.
• Competing against generic propofol’s low price.

The larger issue is demand. Even if patent barriers are no longer material, a generic manufacturer may have little incentive to enter a market with limited branded sales and a powerful incumbent substitute.

What patent litigation and settlements affect fospropofol disodium?

No major active patent litigation or publicly important settlement agreement is associated with fospropofol disodium’s current market position. The product’s commercial failure was not driven by a visible generic litigation campaign.

The absence of significant litigation is itself commercially relevant. It indicates that the asset did not develop the revenue profile needed to support extensive lifecycle-management litigation, authorized-generic planning, or settlement economics.

How strong is the fospropofol disodium patent estate?

The estate was moderately differentiated technically but weak commercially.

Its strengths were:

• A defined prodrug chemistry.
• A formulation distinction from propofol emulsion.
• FDA approval for an injectable sedation indication.
• Potential protection for manufacturing and administration methods.

Its weaknesses were:

• Limited clinical differentiation.
• Dependence on the same active sedative generated from propofol.
• Competition from low-cost generic propofol.
• Narrow commercial indication.
• Limited evidence of durable market demand.
• Expiration or aging of the original patent portfolio.

Overall, the patent estate could support regulatory exclusivity for a period, but it did not create sustainable pricing power.

What is the revenue exposure and market outlook?

Current direct revenue exposure is negligible. Fospropofol disodium is not a meaningful growth asset in the global anesthesia market.

Future value would require one of four changes:

• A new formulation with clear safety or handling benefits.
• A new indication with stronger reimbursement.
• A licensing deal with an anesthesia-focused company.
• Clinical evidence showing an advantage over generic propofol, dexmedetomidine, or remimazolam.

There is no established evidence of a material active licensing program, current commercial relaunch, or significant international revenue base. Geographic coverage was historically centered on the United States, with no indication that international sales created a durable counterbalance to weak U.S. uptake.

Key Takeaways

• Fospropofol disodium was FDA approved as Lusedra in December 2008 for monitored anesthesia care sedation in adults.
• Eisai discontinued U.S. commercial activity after limited market adoption.
• Generic propofol was the principal commercial competitor and undercut fospropofol on price and familiarity.
• The product’s patent estate covered prodrug chemistry, formulations, and sedation methods, but most practical exclusivity value has expired or diminished.
• Fospropofol is a small molecule, so biosimilar risk does not apply.
• No major current Paragraph IV challenge, active patent litigation, or settlement is associated with the product.
• Public disclosures do not support a reliable material revenue estimate.
• The asset’s current value is limited unless a sponsor can establish a new delivery, safety, reimbursement, or clinical advantage.

FAQs About Fospropofol Disodium

Is fospropofol disodium still marketed in the United States?

No durable U.S. commercial market remains for Lusedra. The product was historically approved and commercialized but was later discontinued from active U.S. supply.

Did fospropofol disodium fail because of FDA safety concerns?

The commercial outcome was primarily linked to limited adoption and weak market economics. The product’s label included clinically significant sedation and respiratory risks, but the commercial discontinuation was not established as an FDA safety withdrawal.

Can a generic manufacturer launch fospropofol disodium?

A generic or 505(b)(2) applicant could theoretically pursue the product, subject to FDA requirements. Commercial demand would be the larger obstacle because generic propofol is already inexpensive and broadly accepted.

Is fospropofol disodium covered by biosimilar regulations?

No. Fospropofol disodium is a chemically synthesized small molecule. Follow-on products would be evaluated through generic-drug or hybrid application pathways, not the biosimilar pathway.

Could fospropofol disodium be relaunched?

A relaunch would require a clear commercial proposition, such as a superior injectable formulation, better operating-room handling, reduced adverse events, or an indication with stronger reimbursement. Historical approval alone would not support a viable relaunch.

References

1. Eisai Co., Ltd. (2009). Annual report 2009. Eisai Co., Ltd.

2. Eisai Co., Ltd. (2010). Annual report 2010. Eisai Co., Ltd.

3. U.S. Food and Drug Administration. (2008). Lusedra (fospropofol disodium) injection prescribing information. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2008, December 12). FDA approves Lusedra for monitored anesthesia care. U.S. Department of Health and Human Services.

5. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. U.S. Department of Health and Human Services.