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. Four 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	16
Patent Applications:	3,997
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
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995

International Patents for FLOLAN

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

Country	Patent Number	Title	Estimated Expiration
Finland	791565
Poland	215627
Italy	7825225
Finland	68359
Switzerland	637948	Process for the preparation of prostaglandin derivatives
Monaco	1265
Spain	480597

FLOLAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLOLAN

Introduction

FLOLAN, also known as epoprostenol, is a critical medication for the treatment of pulmonary arterial hypertension (PAH), a severe and progressive disease. Manufactured by GSK (formerly GlaxoSmithKline), FLOLAN has been a cornerstone in PAH treatment since its approval by the FDA. Here, we delve into the market dynamics and financial trajectory of FLOLAN, exploring its impact, challenges, and future prospects.

Historical Context and Approval

FLOLAN was the first drug approved by the FDA for the treatment of PAH, marking a significant milestone in the management of this debilitating condition. Its approval was based on clinical trials that demonstrated improved hemodynamic parameters and survival rates in patients with idiopathic or heritable PAH[4].

Market Position

In the PAH therapeutics market, FLOLAN is categorized under prostacyclins, a class of drugs that also includes Veletri, Remodulin, Selexipag, Tyvaso, and Ventavis. The global PAH therapeutics market is segmented into several drug classes, including endothelin receptor antagonists, PDE-5 inhibitors, and soluble guanylate cyclase stimulators. Prostacyclins, led by FLOLAN, play a vital role in this market due to their efficacy in improving hemodynamic parameters and quality of life for PAH patients[5].

Clinical Efficacy and Impact

FLOLAN has shown significant clinical efficacy in treating PAH. It works by increasing cardiac index and stroke volume while decreasing pulmonary vascular resistance and mean systemic arterial pressure. Clinical trials have demonstrated that FLOLAN improves exercise capacity, reduces symptoms of dyspnea and fatigue, and enhances NYHA functional class in patients with PAH[4].

Supply Chain and Production Issues

Recently, GSK announced supply issues with FLOLAN due to quality concerns in the production process. This has led to a halt in production, forcing specialty pharmacies to transition patients to alternative treatments. The shortage has significant implications for patients who rely on FLOLAN, highlighting the need for robust supply chain management and quality control measures[1].

Financial Performance

The financial performance of FLOLAN is closely tied to GSK's overall pharmaceutical portfolio. In recent years, GSK has focused on optimizing its portfolio, divesting non-core assets, and investing in growth markets. The company has delivered strong financial results, including significant savings from restructuring and improved cash flow. However, the current supply issues with FLOLAN could impact its revenue and profitability in the short term[2].

Net Present Value (NPV) and Valuation

Evaluating the value of FLOLAN involves complex financial modeling, including revenue forecasts, operating profit models, and discounted cash flow analysis. GlobalData's NPV model provides a comprehensive tool for valuing pharmaceutical assets like FLOLAN, considering factors such as market trends, cash inflows and outflows, and potential success rates at various stages of drug development[3].

Market Trends and Growth Prospects

The global PAH therapeutics market is expected to grow driven by increasing awareness of PAH, advancements in treatment options, and an expanding patient population. Prostacyclins, including FLOLAN, are likely to remain a key segment of this market. However, competition from other drug classes and the emergence of new treatments could impact FLOLAN's market share. GSK's ability to navigate these trends and maintain production quality will be crucial for FLOLAN's continued success[5].

Regulatory and Compliance Challenges

Pharmaceutical companies face stringent regulatory requirements, and GSK is no exception. The recent production halt due to quality concerns underscores the importance of compliance with regulatory standards. Ensuring transparency in clinical research and maintaining high ethical standards are also critical for GSK's reputation and the long-term success of FLOLAN[2].

Patient Impact and Support

The halt in FLOLAN production has significant implications for patients, who may experience stress and uncertainty about their treatment. The Pulmonary Hypertension Association and specialty pharmacies are working closely with clinicians to transition patients to alternative treatments, emphasizing the need for patient-centric approaches in managing such disruptions[1].

Future Outlook

Looking ahead, GSK is likely to focus on resolving the current supply issues and ensuring the long-term availability of FLOLAN. The company's commitment to transparency, patient focus, and ethical conduct will be essential in maintaining trust among patients and healthcare professionals. As the PAH therapeutics market continues to evolve, FLOLAN's position will depend on its clinical efficacy, market dynamics, and GSK's strategic management of its pharmaceutical portfolio.

Key Takeaways

• FLOLAN is a critical medication for PAH treatment, approved by the FDA for its efficacy in improving hemodynamic parameters and survival rates.
• Recent supply issues due to quality concerns have impacted patient care and highlight the need for robust supply chain management.
• The financial performance of FLOLAN is tied to GSK's overall pharmaceutical portfolio and is subject to market trends and regulatory compliance.
• The PAH therapeutics market is expected to grow, with prostacyclins like FLOLAN remaining a key segment.
• Patient-centric approaches are crucial in managing treatment disruptions and ensuring continued care.

FAQs

What is FLOLAN used for?

FLOLAN (epoprostenol) is used for the long-term intravenous treatment of idiopathic or heritable pulmonary arterial hypertension (PAH)[4].

Why is there a shortage of FLOLAN?

The current shortage of FLOLAN is due to quality concerns in the production process, leading GSK to halt production temporarily[1].

How does FLOLAN work?

FLOLAN works by increasing cardiac index and stroke volume while decreasing pulmonary vascular resistance and mean systemic arterial pressure, thereby improving hemodynamic parameters in PAH patients[4].

What are the alternatives to FLOLAN for PAH treatment?

Alternatives to FLOLAN include other prostacyclins like Veletri and Remodulin, as well as drugs from other classes such as endothelin receptor antagonists and PDE-5 inhibitors[5].

How does the supply issue affect patients?

The supply issue can cause stress and uncertainty for patients who rely on FLOLAN, necessitating transitions to alternative treatments under the guidance of healthcare professionals[1].

Sources

1. Pulmonary Hypertension Association - Halt in Flolan production causes drug substitutions
2. GSK - Strategic report - GSK
3. GlobalData - Net Present Value Model: Flolan
4. GSK Canada - Flolan Product Monograph
5. PR Newswire - Global Pulmonary Arterial Hypertension (PAH) Therapeutics Industry