Zolinza is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 10 US drug patents filed from 2013 to 2014. Out of these, 3 drug patents are active and 7 have expired. Zolinza's patents have been open to challenges since 06 October, 2010. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 18, 2028. Details of Zolinza'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. | |||
| US7456219 | Polymorphs of suberoylanilide hydroxamic acid |
Mar, 2027
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8450372 | Formulations of suberoylanilide hydroxamic acid and methods for producing same |
Mar, 2028
(2 years from now) | Active |
| US8093295 | Formulations of suberoylanilide hydroxamic acid and methods for producing the same |
May, 2026
(1 year, 2 days from now) | Active |
| US7399787 | Methods of treating cancer with HDAC inhibitors |
Feb, 2025
(3 months ago) |
Expired
|
| US7851509 | Polymorphs of suberoylanilide hydroxamic acid |
Feb, 2024
(1 year, 2 months ago) |
Expired
|
| US8067472 | Methods of treating Hodgkin's and non-Hodgkin's lymphoma |
Mar, 2023
(2 years ago) |
Expired
|
| US7732490 | Methods of treating cancer |
Mar, 2023
(2 years ago) |
Expired
|
| US7652069 | Polymorphs of suberoylanilide hydroxamic acid |
Mar, 2023
(2 years ago) |
Expired
|
| US8101663 | Polymorphs of suberoylanilide hydroxamic acid |
Mar, 2023
(2 years ago) |
Expired
|
| USRE38506 | Potent inducers of terminal differentiation and methods of use thereof |
Nov, 2013
(11 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 Zolinza's patents.
Latest Legal Activities on Zolinza's Patents
Given below is the list of recent legal activities going on the following patents of Zolinza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 01 Jan, 2024 | US8067472 |
| Maintenance Fee Reminder Mailed Critical | 17 Jul, 2023 | US8067472 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Jun, 2023 | US8093295 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 May, 2022 | US7851509 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Nov, 2021 | US7732490 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Jun, 2021 | US7652069 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8450372 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Apr, 2020 | US7456219 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Dec, 2019 | US7399787 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jun, 2019 | US8093295 |
FDA has granted several exclusivities to Zolinza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zolinza, 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 Zolinza.
Exclusivity Information
Zolinza holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Zolinza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 06, 2011 |
| Orphan Drug Exclusivity(ODE) | Oct 06, 2013 |
Several oppositions have been filed on Zolinza'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 Zolinza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zolinza patents.
Zolinza's Oppositions Filed in EPO
Zolinza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 22, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP03711372A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP03711372A | May, 2013 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Zolinza 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 Zolinza's family patents as well as insights into ongoing legal events on those patents.
Zolinza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zolinza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 18, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zolinza Generics:
There are no approved generic versions for Zolinza as of now.
About Zolinza
Zolinza is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for treating cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL). Zolinza uses Vorinostat as an active ingredient. Zolinza was launched by Msd Sub Merck in 2006.
Can you believe Zolinza received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Zolinza was approved by FDA for market use on 06 October, 2006.
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 Zolinza is 06 October, 2006, its NCE-1 date is estimated to be 06 October, 2010.
Active Ingredient:
Zolinza uses Vorinostat as the active ingredient. Check out other Drugs and Companies using Vorinostat ingredient
Treatment:
Zolinza is used for treating cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL).
Dosage:
Zolinza is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE | Prescription | ORAL |