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:	104
Clinical Trials:	12
Patent Applications:	1,285
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

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
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	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
Germany	60131179
Poland	361408
South Korea	100585484

Supplementary Protection Certificates for FARYDAK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1912640	PA2016003,C1912640	Lithuania		PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	122015000098	Germany		PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828

Market Dynamics and Financial Trajectory for FARYDAK (Panobinostat)

Introduction

FARYDAK, also known as panobinostat, is a histone deacetylase (HDAC) inhibitor that was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for the treatment of multiple myeloma. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its approval, usage, financial performance, and eventual withdrawal from the U.S. market.

Approval and Indication

FARYDAK was approved under the FDA's accelerated approval program for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who had received at least two prior regimens, including bortezomib and an immunomodulatory agent. This approval was based on the drug's ability to prolong progression-free survival (PFS) in these patients[4].

Clinical Benefits and Safety Profile

The clinical benefit of FARYDAK was initially demonstrated through its ability to extend the median PFS from 6 to 11 months when used in combination with bortezomib and dexamethasone. However, the drug's approval was contingent upon the completion of further adequate and well-controlled clinical studies to verify and describe its clinical benefit[1][4].

FARYDAK's safety profile includes serious adverse reactions such as hemorrhage, myelosuppression, infections, hepatotoxicity, and embryo-fetal toxicity. The FDA also approved a risk evaluation and mitigation strategy (REMS) for FARYDAK to inform and educate healthcare professionals about these risks[4].

Market Dynamics

Competitive Landscape

In the multiple myeloma market, FARYDAK competed with other drugs such as Revlimid, Darzalex, Kyprolis, and Velcade. The market dynamics were influenced by the introduction of new formulations and the performance of these drugs in clinical trials. For example, the approval of Darzalex Faspro, a subcutaneous injection version of Darzalex, provided an alternative to intravenous administration and enhanced its appeal to clinicians[3].

Sales and Revenue

Although specific sales figures for FARYDAK are not widely available, its market presence was significant enough to warrant continued regulatory submissions and marketing efforts in various regions. However, the drug's sales were likely impacted by the competitive landscape and the need for confirmatory clinical trials to maintain its approval[1][4].

Financial Trajectory

Initial Success and Challenges

Following its approval, FARYDAK was marketed by Novartis and later acquired by Secura Bio in March 2019. The drug's initial success was tied to its innovative mechanism of action as an HDAC inhibitor, which represented a new drug class in multiple myeloma treatment[4].

Withdrawal from the U.S. Market

In November 2021, Secura Bio announced the withdrawal of FARYDAK's approval in the U.S. due to the company's inability to complete the required post-approval clinical studies as designed. This decision was made after discussions with the FDA, highlighting the challenges in verifying and describing the clinical benefit of the drug under the accelerated approval process[1].

Global Market Presence

Despite the withdrawal from the U.S. market, Secura Bio and its partners continued to market FARYDAK in other regions where it had been approved. This indicates that the drug still had a viable market presence outside the U.S.[1].

Financial Implications

Impact on Secura Bio

The withdrawal of FARYDAK's approval in the U.S. had significant financial implications for Secura Bio. The company's inability to complete the necessary clinical trials meant that it could not realize the full potential revenue from the drug in the U.S. market. This decision likely affected the company's financial performance and its ability to invest in other research and development projects[1].

Broader Financial Context

The pharmaceutical industry is highly competitive and capital-intensive. Companies like Secura Bio face significant financial challenges, including the costs of clinical trials, regulatory compliance, and market competition. The failure to secure approval or maintain market presence can lead to substantial financial losses and impact the company's overall viability[2].

Key Takeaways

• Approval and Indication: FARYDAK was approved for multiple myeloma treatment under the FDA's accelerated approval program.
• Clinical Benefits and Safety: The drug extended PFS but had a significant safety profile that required a REMS program.
• Market Dynamics: FARYDAK competed in a crowded multiple myeloma market with other drugs like Revlimid and Darzalex.
• Financial Trajectory: The drug's financial success was hampered by the inability to complete post-approval clinical trials, leading to its withdrawal from the U.S. market.
• Global Presence: Despite U.S. withdrawal, FARYDAK continued to be marketed in other regions.

FAQs

What is FARYDAK used for?

FARYDAK (panobinostat) is used in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent[4].

Why was FARYDAK withdrawn from the U.S. market?

FARYDAK was withdrawn from the U.S. market because Secura Bio was unable to complete the required post-approval clinical studies to verify and describe the clinical benefit of the drug as part of the FDA's accelerated approval process[1].

What are the serious adverse reactions associated with FARYDAK?

Serious adverse reactions include hemorrhage, myelosuppression, infections, hepatotoxicity, and embryo-fetal toxicity[4].

How does FARYDAK compare to other multiple myeloma treatments?

FARYDAK competes with drugs like Revlimid, Darzalex, Kyprolis, and Velcade. It was the first HDAC inhibitor approved for multiple myeloma, offering a unique mechanism of action but facing competition from other effective treatments[3][4].

What is the current market status of FARYDAK outside the U.S.?

Despite its withdrawal from the U.S. market, FARYDAK continues to be marketed in other regions where it has been approved[1].

Sources

1. Secura Bio Announces U.S. Withdrawal of FARYDAK (Panobinostat) NDA - PR Newswire
2. Preliminary Results for the Year Ended 31 December 2022 - Biodexa Pharma
3. Financial Analysis of Competitive Drugs with PharmaKB - PharmaKB
4. Novartis receives FDA approval of Farydak, the first HDAC inhibitor for patients with multiple myeloma - Novartis

Last updated: 2024-12-16