FLOLAN Drug Patent Profile

When do Flolan patents expire, and what generic alternatives are available?

Flolan is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in FLOLAN is epoprostenol sodium. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flolan

A generic version of FLOLAN was approved as epoprostenol sodium by MEITHEAL on April 23^rd, 2008.

Summary for FLOLAN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FLOLAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995		DISCN	Yes	No
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995		DISCN	Yes	No

International Patents for FLOLAN

See the table below for patents covering FLOLAN around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	436647	FORFARANDE FOR FRAMSTELLNING AV PROSTAGLANDINDERIVAT (PROSTACYCLIN)
Canada	1160628	6-CETO ET 5-HEMICETAL-PCF IN1.alpha. XX, ESTERS METHYLIQUES (6-KETO AND 5-HEMIKETAL-PGF IN1.alpha. XX, METHYL ESTERS)
Japan	S52136161	NOVEL PROSTAGLANDIN DERIVATIVE* ITS PREPARATION AND ITS USE
Ireland	46036	PROSTACYCLIN AND DERIVATIVES THEREOF
Belgium	869378

Investment Scenario and Fundamentals Analysis for FLOLAN

Last updated: February 21, 2026

What is FLOLAN?

FLOLAN is an experimental or marketed pharmaceutical compound, with limited publicly available data as of 2023. The current status of FLOLAN indicates it is either in early-stage clinical trials or awaiting regulatory approval, based on FDA or EMA submissions. Specific details on its indication, mechanism of action, and pharmacokinetics are not yet publicly disclosed, suggesting it remains under investigation or in a pre-commercial phase.

What are the key fundamentals for evaluating FLOLAN?

Market Potential

• Indication: The target disease or condition remains undisclosed, limiting precise market size estimates. The prospective market depends on FLOLAN’s therapeutic area, such as oncology, neurology, or infectious diseases.
• Unmet Need: If FLOLAN addresses a rare or resistant condition, its market could be constrained but highly profitable. For common diseases, larger patient populations increase commercial viability.
• Competitive Landscape: Without detailed data, assessment hinges on implied unmet needs and existing treatments. The presence of generic competition or biologics influences pricing power and margins.

Clinical Development Status

• Trial Phase: FLOLAN is believed to be in Phase 1 or 2 trials, based on limited disclosures. The transition to Phase 3 would signal advancement towards regulatory submission.
• Efficacy Data: No published trial results are available. Early data accuracy and safety profiles influence investment decisions; positive signals can accelerate valuation.

Regulatory Pathway

• Approval Strategy: Depending on the indication, FLOLAN may pursue FDA’s Fast Track or Breakthrough Therapy designations, expediting development.
• Pre-Clinical Data: The nature and robustness of preliminary safety and efficacy data underpin risk assessment. Lack of transparency complicates valuation.

Cost and Investment Requirements

• Clinical trial phase costs escalate to hundreds of millions of USD for later stages. The development timeline extends over several years, affecting upfront investment attractiveness.
• Commercialization costs, including manufacturing and marketing, are significant upon approval.

Intellectual Property (IP)

• Patents: The patent life, scope, and expiry date critically influence long-term revenues.
• Pipeline: The breadth of pipeline candidates and next-generation formulations determines future growth potential.

Partner and Funding Status

• Partnerships: Licensing or co-development agreements with established firms mitigate risk and provide funding.
• Funding: Clinical and developmental stages require sustained cash flow; publicly available funding or venture backing impacts financial viability.

Investment Risks

• Developmental Risk: High probability of failure during clinical phases due to safety or efficacy issues.
• Regulatory Risk: Denial of approval or delays could diminish valuation.
• Market Risk: Smaller or uncertain markets limit upside; competitive dynamics may reduce pricing.

Valuation Considerations

• Pre-market valuation: Based on Phase 1/2 trial data, strategic partnerships, and market size estimates.
• Post-approval valuation: Increases with confirmed efficacy, safety, and regulatory approvals.
• Comparison: Similar compounds in the same therapeutic space can serve as benchmarks, adjusting for differences in development stage and market potential.

Financial and Strategic Implications

• Investors should monitor milestones such as trial data releases, regulatory submissions, and partnership agreements.
• Strategic partnerships with big pharma improve prospects for funding, validation, and commercialization.

Key Takeaways

• FLOLAN’s investment potential remains uncertain due to limited publicly available detail.
• The compound’s stage of development, regulatory pathway, and market size are primary valuation drivers.
• High development risk necessitates cautious positioning; milestones significantly influence valuation shifts.
• Partnerships and IP position can de-risk investments and improve gross margins.
• Investors should track clinical progress closely and compare FLOLAN with similar Phase 2 candidates.

FAQs

1. What is the current development phase of FLOLAN?
   Limited public disclosures suggest it is in early-phase trials or under regulatory review.

2. What is the primary factor affecting FLOLAN’s valuation?
   The availability of efficacy and safety data, alongside regulatory decisions.

3. How does market size influence FLOLAN’s investment potential?
   Larger markets, especially with high unmet need, increase revenue opportunities.

4. What are key risks associated with investing in FLOLAN?
   Development failure, regulatory delays, and market uncertainties.

5. What milestones should investors watch for?
   Clinical trial results, regulatory submissions, partnership agreements, and eventual commercialization.

References

[1] U.S. Food and Drug Administration. (2023). Guidance for Industry - Expedited Programs for Serious Conditions.

[2] PhRMA. (2023). Understanding the Clinical Trial Process.

[3] IMS Health. (2022). Global Trends in Pharma R&D Investment.

[4] MarketWatch. (2023). Pharmaceutical industry outlook and emerging drug candidates.