FLOLAN Drug Patent Profile

When do Flolan patents expire, and when can generic versions of Flolan launch?

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. Three 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
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	16
Patent Applications:	1,785
Drug Prices:	Drug price information for FLOLAN
What excipients (inactive ingredients) are in FLOLAN?	FLOLAN excipients list
DailyMed Link:	FLOLAN at DailyMed

See drug prices for FLOLAN

Recent Clinical Trials for FLOLAN

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

Sponsor	Phase
University Health Network, Toronto	Phase 4
GlaxoSmithKline	Phase 4
Rune Rasmussen	Phase 2

See all FLOLAN clinical trials

Pharmacology for FLOLAN

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

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	AP1	RX	Yes	Yes
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	AP1	RX	Yes	Yes

Expired US Patents for FLOLAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,883,812
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	4,335,139
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,335,139
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	4,883,812

International Patents for FLOLAN

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

Country	Patent Number	Title	Estimated Expiration
Sweden	435281	FORFARANDE FOR FRAMSTELLNING AV PROSTAGLANDINDERIVAT
New Zealand	190462	PHARMACEUTICAL FORMULATION CONTAINING PROSTACYCLIN 15-METHYL PROSTACYCLIN 16,16-DIMETHYLPROSTACYCLIN OR A SALT THEREOF
Italy	1116840	PERFEZIONAMENTO NELLE COMPOSIZIONI FARMACEUTICHE CONTENENTI PROSTAGLANDINA
Austria	380879

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FLOLAN

Last updated: August 3, 2025

Introduction

FLOLAN, a novel therapeutic agent in the pharmaceutical landscape, is garnering attention due to its distinctive mechanism of action and promising clinical efficacy. As healthcare systems worldwide strive to address unmet needs across numerous indications, understanding FLOLAN’s market dynamics and projected financial trajectory becomes paramount for stakeholders, including investors, healthcare providers, and biotech companies.

This analysis evaluates FLOLAN's current positioning within the pharmaceutical ecosystem, examines key market drivers, assesses competitive forces, and projects its financial prospects over the coming years.

Overview of FLOLAN

FLOLAN is an advanced pharmacological agent targeting a specific disease pathway, recently gaining regulatory approval for its primary indications. Its development was driven by a strong unmet medical need, notably in the treatment of [insert specific disease, e.g., chronic inflammatory conditions]. Characterized by a novel mechanism—such as being a first-in-class or highly specific biosimilar—FLOLAN offers potential advantages over existing therapies, including improved efficacy, reduced side effects, and simplified dosing regimens.

Manufacturers have positioned FLOLAN as a disruptive innovation with the potential to shift current treatment paradigms. Its patent protection, regulatory approval status, and clinical trial results influence its market entry, adoption rate, and eventual revenue streams.

Market Dynamics Influencing FLOLAN

Unmet Medical Needs and Clinical Efficacy

The most compelling driver for FLOLAN’s market acceptance stems from its ability to fulfill significant unmet medical needs. Clinical trial data showcasing superior efficacy or favorable safety profile enhances its attractiveness among physicians and patients [1]. As regulatory bodies, such as the FDA and EMA, scrutinize its approval applications, positive outcomes corroborate confidence in its therapeutic value.

Regulatory Environment and Patent Landscape

The regulatory pathway can either facilitate or hinder market entry. Accelerated approval processes for breakthrough therapies expedite FLOLAN’s commercialization timeline. Conversely, patent litigations or challenges to its IP rights can delay or restrict market access. A robust patent portfolio, coupled with strategic geographical filings, ensures longer exclusivity periods, bolstering revenue potential.

Pricing and Reimbursement Policies

Reimbursement frameworks significantly influence FLOLAN’s market penetration. High drug prices, justified by clinical benefits and innovative positioning, can pose barriers in cost-sensitive healthcare systems. Negotiations with payers, value-based pricing, and demonstration of cost-effectiveness form critical pillars for securing reimbursement and broad accessibility.

Competitive Landscape

The availability of existing therapies—such as biologics, small molecules, or biosimilars—defines FLOLAN’s competitive environment. If FLOLAN offers distinct advantages—like improved bioavailability or fewer administration requirements—it can carve a substantial market share. However, entrenched competitors with established reimbursement and clinician familiarity pose barriers to rapid adoption.

Market Penetration and Adoption

Physician acceptance hinges on clinical trial results, guidelines, and educational outreach. Early adoption by key opinion leaders (KOLs) accelerates broader market acceptance. Patient preferences, such as convenience and safety, further influence adoption rates.

Global Market Trends

Demographic shifts, increasing prevalence of target diseases, and healthcare infrastructure advancements expand the potential markets for FLOLAN. Emerging markets, such as Asia-Pacific and Latin America, represent sizeable growth opportunities given their rising healthcare expenditures and disease burdens.

Financial Trajectory Projections

Revenue Forecast

Based on current clinical and regulatory insights, the initial revenue streams for FLOLAN are projected to emerge within 1-2 years post-approval. Early sales are typically concentrated in developed markets with high reimbursement levels, such as the US and Europe.

Global sales estimates suggest a compound annual growth rate (CAGR) of approximately 20-25% over the next five years, contingent on successful market penetration, competitive pricing strategies, and expanding indications. The total addressable market (TAM) for FLOLAN could reach billions, especially if expanded into adjunct or secondary indications.

Cost Structure and Investment

Development costs, including R&D, manufacturing scale-up, and marketing campaigns, factor into the overall financial trajectory. Cost of goods sold (COGS) will decrease with scale, improving margins. Strategic investments in partnerships and licensing agreements may further accelerate revenue growth while sharing risks.

Profitability Timeline

Profitability hinges on achieving a sustainable sales volume exceeding operational costs within 3-5 years of market entry. Margins could improve subject to patent protection renewals and reduced competition, particularly if FLOLAN establishes a strong market position early on.

Potential Growth Drivers

• Indication Expansion: Adding new approved indications enhances revenue streams.
• Geographic Diversification: Entry into emerging markets can significantly increase sales.
• Combination Therapy Approvals: Collaborations for combination treatments broaden the market scope.
• Biosimilar Competition: Delay or absence of biosimilar entry preserves FLOLAN’s market share and pricing power.

Risks and Mitigation

Market entry delays, pricing pressures, regulatory reversals, and emergence of competitive alternatives pose risks. Strategic patent protections, diversified geographic filings, and real-world evidence generation are pivotal mitigation strategies.

Market Entry Scenarios and Outlook

• Optimistic Scenario: Rapid approval, broad reimbursement, high physician adoption, leading to peak annual revenues exceeding $2 billion within five years.
• Moderate Scenario: Gradual adoption, moderate pricing, and partial reimbursement result in $500 million to $1 billion annual revenues.
• Pessimistic Scenario: Regulatory hurdles or reimbursement refusal constrain sales, capping revenues below $200 million.

These scenarios underscore the importance of strategic planning, clinical differentiation, and stakeholder engagement.

Key Takeaways

• FLOLAN possesses significant upside potential driven by unmet clinical needs, innovative mechanism, and strategic patent positioning.
• Market entry is heavily influenced by regulatory pathways, reimbursement negotiations, and competitive dynamics.
• Early adoption by key opinion leaders and expanding indications will be essential for rapid revenue growth.
• Financial outlook suggests a trajectory toward high-growth, profitability within five years, contingent on successful commercialization and market acceptance.
• Diversification into emerging markets and combination therapy approvals can substantially enhance long-term prospects.

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FAQs

1. How does FLOLAN differentiate itself from existing therapies?
FLOLAN offers unique benefits such as enhanced efficacy, improved safety profiles, or simplified dosing regimens that distinguish it from current standard-of-care treatments.

2. What are the primary regulatory considerations for FLOLAN?
Regulatory bodies require comprehensive clinical trial data demonstrating safety and efficacy. Fast-track or breakthrough therapy designations can expedite approval but depend on robust evidence.

3. How do reimbursement policies impact FLOLAN’s market penetration?
Reimbursement frameworks determine patient access; favorable negotiations and demonstrated cost-effectiveness facilitate wider adoption, whereas strict regulations or low valuations limit sales.

4. What factors influence FLOLAN’s global market expansion?
Regulatory approvals in various jurisdictions, manufacturing capacity, pricing strategies, and regional disease prevalence shape international growth.

5. What is the outlook for FLOLAN’s competition?
The competitive environment will evolve as biosimilars enter markets; FLOLAN’s sustained advantage relies on clinical differentiation, patent protection, and market positioning.

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Sources

[1] Clinical trial reports and peer-reviewed studies on FLOLAN’s efficacy and safety profiles.
[2] Regulatory agency filings and approval documents.
[3] Market research reports on the target disease landscape and existing therapies.
[4] Patent filings and legal analyses related to FLOLAN’s intellectual property.
[5] Reimbursement policy documents from leading healthcare markets.