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:	4,965
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, 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.

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	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	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:

Australia

Chile

Honduras

Nicaragua

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
Argentina	035057	COMPUESTOS DE N-HIDROXI-3-FENIL-2E-2-PROPENAMIDA, COMPOSICIONES FARMACEUTICAS Y EL USO DE DICHOS COMPUESTOS PARA LA MANUFACTURA DE UN MEDICAMENTO PARA UN DESORDEN PROLIFERATIVO
Austria	376999
Australia	2001282129

Supplementary Protection Certificates for FARYDAK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	CA 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1912640	PA2016003	Lithuania		PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	92890	Luxembourg		PRODUCT NAME: PANOBINSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE , OU UN DERIVE DE CELUI-CI (FARYDAK); FIRST REGISTRATION: 20150901