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. Farydak's patents have been open to challenges since 23 February, 2019. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7989494 | Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide |
Jan, 2028
(2 years from now) | Active |
| US6833384 | Deacetylase inhibitors |
Sep, 2021
(3 years ago) |
Expired
|
| US6552065 | Deacetylase inhibitors |
Aug, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8883842 | Use of HDAC inhibitors for the treatment of myeloma |
Jun, 2028
(2 years from now) | Active |
| US7067551 | Deacetylase inhibitors |
Aug, 2021
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Farydak's patents.
Latest Legal Activities on Farydak's Patents
Given below is the list of recent legal activities going on the following patents of Farydak.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 25 Jan, 2023 | US7989494 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 11 May, 2022 | US8883842 |
| Patent Term Extension Certificate Critical | 29 Jan, 2021 | US6833384 |
| Withdrawal of Application for PTE Critical | 29 Jan, 2021 | US6552065 |
| Withdrawal of Application for PTE Critical | 29 Jan, 2021 | US7067551 |
| Election in Response to Notice of Final Determination | 30 Nov, 2020 | US6833384 |
| Notice of Final Determination -Election Required | 13 Nov, 2020 | US6833384 |
| Notice of Final Determination -Election Required | 13 Nov, 2020 | US7067551 |
| Notice of Final Determination -Election Required | 13 Nov, 2020 | US6552065 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 05 Nov, 2020 | US6552065 |
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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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.
Approval Date:
Farydak was approved by FDA for market use on 23 February, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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
Treatment:
Farydak is used for treating multiple myeloma in combination with bortezomib and dexamethasone.
Dosage:
Farydak is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 15MG BASE | CAPSULE | Discontinued | ORAL |
| EQ 10MG BASE | CAPSULE | Discontinued | ORAL |
| EQ 20MG BASE | CAPSULE | Discontinued | ORAL |