Farydak Patent Expiration

Farydak is a drug owned by Secura Bio Inc. It is protected by 5 US drug patents filed in 2015. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 13, 2028. Details of Farydak's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6552065 Deacetylase inhibitors
Aug, 2021

(2 years ago)

US6833384 Deacetylase inhibitors
Sep, 2021

(2 years ago)

US7989494 Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide
Jan, 2028

(3 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7067551 Deacetylase inhibitors
Aug, 2021

(2 years ago)

US8883842 Use of HDAC inhibitors for the treatment of myeloma
Jun, 2028

(3 years from now)


FDA has granted several exclusivities to Farydak. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Farydak, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Farydak.

Exclusivity Information

Farydak holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Farydak's exclusivity codes and their expiration dates are given below.

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Feb 23, 2020
Orphan Drug Exclusivity(ODE) Feb 23, 2022
Orphan Drug Exclusivity(ODE-89) Feb 23, 2022

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Several oppositions have been filed on Farydak's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Farydak's generic, the next section provides detailed information on ongoing and past EP oppositions related to Farydak patents.

Farydak's oppositions filed in EPO

Farydak has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 17, 2016, by Generics [Uk] Limited. This opposition was filed on patent number EP06789025A. Click below to reveal the latest opposition data.

Application Filing Date Opposition Party Legal Status
Patent litigations
EP06789025A Mar, 2016 Generics [UK] Limited Opposition rejected

US patents provide insights into the exclusivity only within the United States, but Farydak is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Farydak's family patents as well as insights into ongoing legal events on those patents.

Farydak's family patents

Farydak has patent protection in a total of 40 countries. It's US patent count contributes only to 14.9% of its total global patent coverage. 17 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Farydak.

Family Patents

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Generic Launch

Generic Release Date:

Farydak's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 13, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Farydak Generics:

There are no approved generic versions for Farydak as of now.

About Farydak

Farydak is a drug owned by Secura Bio Inc. It is used for treating multiple myeloma in combination with bortezomib and dexamethasone. Farydak uses Panobinostat Lactate as an active ingredient. Farydak was launched by Secura in 2015.

Market Authorisation Date:

Farydak was approved by FDA for market use on 23 February, 2015.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Farydak is 23 February, 2015, its NCE-1 date is estimated to be 23 February, 2019

Active Ingredient:

Farydak uses Panobinostat Lactate as the active ingredient. Check out other Drugs and Companies using Panobinostat Lactate ingredient


Farydak is used for treating multiple myeloma in combination with bortezomib and dexamethasone.


Farydak is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway