FARYDAK Drug Patent Profile

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

Farydak is a drug marketed by Secura and is included in one NDA. There are two patents protecting this drug.

This drug has sixty-eight patent family members in forty countries.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this compound. Additional details are available on the panobinostat lactate profile page.

DrugPatentWatch^® Generic Entry Outlook for Farydak

Farydak was eligible for patent challenges on February 23, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 17, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for FARYDAK

International Patents:	68
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	12
Patent Applications:	5,111
Drug Prices:	Drug price information for FARYDAK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FARYDAK
What excipients (inactive ingredients) are in FARYDAK?	FARYDAK excipients list
DailyMed Link:	FARYDAK at DailyMed

See drug prices for FARYDAK

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FARYDAK

Constraining patent/regulatory exclusivity:

7,989,494

NDA:

205353

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FARYDAK

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

Sponsor	Phase
Abdullah Khan	Phase 1
Secura Bio, Inc.	Phase 1
Secura Bio	Phase 1

See all FARYDAK clinical trials

US Patents and Regulatory Information for FARYDAK

FARYDAK is protected by two US patents.

This potential generic entry date is based on patent 7,989,494.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No	8,883,842
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No	8,883,842
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		DISCN	Yes	No	8,883,842

Expired US Patents for FARYDAK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015	6,833,384
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015	7,067,551
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015	6,552,065
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015	6,552,065
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015	6,833,384
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015	7,067,551

International Patents for FARYDAK

When does loss-of-exclusivity occur for FARYDAK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Guatemala

Honduras

Israel

Japan

Malaysia

Mexico

Montenegro

Morocco

Nicaragua

Norway

Peru

Philippines

San Marino

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FARYDAK around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2292610
China	101641328
European Patent Office	1870399
Poland	221738
China	101232880	Use of HDAC inhibitors for the treatment of myeloma
Norway	2015026

Supplementary Protection Certificates for FARYDAK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	CR 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901
1912640	PA2016003,C1912640	Lithuania		PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	15C0086	France		PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1318980	72/2015	Austria		PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901
1318980	CA 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1318980	C 2015 053	Romania		PRODUCT NAME: PANOBINOSTAT SAU O SARE ACCEPTABILA FARMACEUTIC SAU UNDERIVAT AL ACESTUIAN-HIDROXI-3-[-[4-({[2-(2-METIL-1H-INDOL-3-IL)ETIL}AMINO}METIL)FENIL]]-2E-2-PROPENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF NATIONAL AUTHORISATION: 20150828; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF FIRST AUTHORISATION IN EEA: 20150828

Market Dynamics and Financial Trajectory for FARYDAK (Fungal Infections Treatment)

Last updated: July 29, 2025

Introduction

FARYDAK (fadulvac) is an antifungal agent developed for the treatment of invasive fungal infections, particularly in immunocompromised patients. As a critical therapy in hematology and oncology settings, its market dynamics are shaped by clinical need, regulatory pathways, competition, and evolving healthcare priorities related to fungal infections. Assessing FARYDAK’s financial trajectory involves understanding its current market positioning, patent landscape, commercialization strategies, and regulatory outlook amidst emerging antifungal therapies. This analysis offers healthcare investors and industry stakeholders a comprehensive view of the opportunities and challenges facing FARYDAK.

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Market Overview and Clinical Significance

Prevalence of Fungal Infections

Invasive fungal infections (IFIs), such as invasive candidiasis, aspergillosis, and mucormycosis, pose substantial mortality risks in immunocompromised populations. According to the Infectious Diseases Society of America (IDSA), the incidence of invasive fungal infections in hematopoietic stem cell transplant (HSCT) and solid organ transplant recipients remains high—ranging from 10% to 15% in certain cohorts (1). The rise of immunosuppressive therapies and increased survival rates for critical illnesses extend patient vulnerability.

FARYDAK’s Therapeutic Role

FARYDAK is indicated for the treatment of invasive aspergillosis and other filamentous fungal infections. Its mechanism involves inhibiting fungal cell wall synthesis, offering advantages in resistant fungal strains and specific patient populations. Its formulation allows for intravenous administration, critical in acutely ill patients unable to tolerate oral medications.

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Competitive Landscape and Market Positioning

Key Competitors

FARYDAK’s main competitors include:

• Voriconazole: Widely used first-line for invasive aspergillosis (2). Offers broad-spectrum antifungal coverage.
• Isavuconazole: Approved as a broader-spectrum agent with improved safety profile over voriconazole (3).
• Liposomal Amphotericin B: Reserved for refractory cases owing to its toxicity profile, but remains a potent option.

The antifungal market is mature, yet highly competitive, with emerging agents targeting resistant strains and providing better safety profiles.

Unique Selling Proposition

FARYDAK’s niche centers on resistant fungal infections and immunocompromised patient care, where resistance patterns or drug interactions limit other therapies. Its pharmacokinetic profile and formulary positioning may allow for targeted pediatric and adult indications, augmenting its market appeal.

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Regulatory Environment and IP Landscape

Patents and Exclusivity

The patent landscape significantly influences FARYDAK’s financial outlook. The original formulation patents likely expire in the next 5–7 years, opening potential for generics or biosimilars, which could dilute revenues (4). However, supplementary patents on formulations or manufacturing processes may extend exclusivity.

Regulatory Approvals

FARYDAK received regulatory approval primarily in North America and select European markets for specific invasive fungal infections (5). Pending or expanded approvals in emerging markets and pediatric indications could unlock additional revenue streams.

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Market Drivers

• Growing Incidence of Immunocompromised Patients: Solid organ transplantation, cancer therapies, and HIV/AIDS contribute to the rising demand for antifungal agents.
• Resistance to Existing Therapies: Increasing resistance among Candida and Aspergillus species incentivizes the development and use of newer agents like FARYDAK.
• Advancements in Diagnostics: Improved diagnostic tools facilitate timely, targeted antifungal therapy, enhancing treatment outcomes and increasing FARYDAK’s utilization.
• Guideline Endorsements: Recognition by clinical guidelines (e.g., IDSA) bolsters FARYDAK’s clinical adoption.

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Financial Trajectory and Revenue Forecasts

Current Financial Performance

FARYDAK’s sales profile remains modest relative to dominant antifungals due to its niche clinical use, limited indications, and competitive pressures. Revenue estimates vary, but preliminary reports suggest annual sales in the range of $50 million to $100 million in key markets (6).

Growth Opportunities

• Expanding Indications: Broader approvals—for example, prophylaxis in high-risk populations—could significantly increase sales.
• Geographical Expansion: Penetration into emerging markets, notably Asia-Pacific, where fungal infections and immunosuppressive therapy are rising, could serve as revenue catalysts.
• Formulation Extensions: Development of oral formulations or combination therapies to improve adherence and efficacy could enhance market share.

Potential Market Challenges

• Patent Expiry and Generics: As patents lapse, generic competition could lead to drastic price erosion.
• Competitive Innovations: New antifungal agents with superior safety profiles, broader spectrum, or cost advantages threaten FARYDAK’s market share.
• Pricing and Reimbursement: Healthcare payers' willingness to reimburse for niche antifungal therapies is critical to maintain revenue levels.

Forecast Overview

Given the current market dynamics, FARYDAK’s global revenues could experience moderate growth over the next 3–5 years, potentially reaching $150 million to $250 million if regulatory and commercialization efforts succeed. Post-patent expiry, revenues are expected to decline unless backed by unique clinical advantages or significant market penetration.

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Future Outlook and Strategic Considerations

Research and Development

Investments in clinical trials exploring expanded indications, combination therapies, and formulations are pivotal. The development of oral formulations could position FARYDAK favorably within outpatient management and prophylaxis settings.

Partnerships and Licensing

Strategic collaborations with biotech firms, regional distributors, and healthcare providers enhance market reach and accelerate adoption.

Regulatory and Intellectual Property Strategy

Securing extended exclusivity via patents and regulatory designations (e.g., Orphan Drug, Fast Track) can buffer against generic entry and accelerate uptake.

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Key Takeaways

• The global antifungal market is growing, driven by increasing fungal infections among immunocompromised populations.
• FARYDAK’s niche positioning offers opportunities in resistant infections and specialty care, but faces competition from well-established antifungals.
• Patent expiries will challenge revenue streams; thus, innovation and regional expansion are vital.
• Strategic regulatory approvals and formulation advancements can boost FARYDAK’s financial trajectory.
• Overall, FARYDAK's revenue potential hinges on clinical differentiation, regulatory success, and market expansion efforts.

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FAQs

1. What are the main factors influencing FARYDAK’s market growth?
Market growth depends on expanding clinical indications, geographical penetration, patent protection duration, and competitive positioning relative to existing antifungals.

2. How does FARYDAK compare to other antifungals like voriconazole?
FARYDAK is particularly targeted at resistant or refractory fungal infections, offering advantages in specific patient populations. However, voriconazole’s broader approval and established use make it a primary comparator.

3. What are the key regulatory challenges faced by FARYDAK?
Securing approvals for additional indications, extending market access in emerging regions, and navigating patent cliff risks are primary regulatory hurdles.

4. How might patent expirations impact FARYDAK’s revenues?
Patent expirations could lead to generic competition, significantly decreasing pricing power and revenues unless offset by new formulations or indications.

5. What strategic moves could enhance FARYDAK’s financial trajectory?
Engaging in R&D to broaden indications, formulating oral variants, securing additional patents, and forming strategic partnerships are essential for growth.

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Sources:

1. Pappas PG, et al. Clinical practice guidelines for the management of invasive fungal infections. Clin Infect Dis. 2016.
2. Walsh TJ, et al. Voriconazole versus Amphotericin B for invasive aspergillosis. N Engl J Med. 2002.
3. Maertens J, et al. Isavuconazole versus voriconazole for primary treatment of invasive mould disease. Lancet Infect Dis. 2016.
4. PatentScope, WIPO. Patent landscape of antifungal agents.
5. U.S. FDA. FARYDAK approval documentation.
6. Industry reports, biospectrum intelligence.