Zolinza Patent Expiration

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, 4 drug patents are active and 6 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

(2 years 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

(3 years from now)

Active
US8093295 Formulations of suberoylanilide hydroxamic acid and methods for producing the same
May, 2026

(1 year, 4 months from now)

Active
US7399787 Methods of treating cancer with HDAC inhibitors
Feb, 2025

(a month from now)

Active
US7851509 Polymorphs of suberoylanilide hydroxamic acid
Feb, 2024

(10 months ago)

Expired
US8067472 Methods of treating Hodgkin's and non-Hodgkin's lymphoma
Mar, 2023

(1 year, 9 months ago)

Expired
US7732490 Methods of treating cancer
Mar, 2023

(1 year, 9 months ago)

Expired
US7652069 Polymorphs of suberoylanilide hydroxamic acid
Mar, 2023

(1 year, 9 months ago)

Expired
US8101663 Polymorphs of suberoylanilide hydroxamic acid
Mar, 2023

(1 year, 9 months 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.

Given below is the list of recent legal activities going on the following patents of Zolinza.

Activity Date Patent Number
Patent litigations
Expire Patent 01 Jan, 2024 US8067472
Maintenance Fee Reminder Mailed 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

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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
Patent litigations
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

Zolinza has patent protection in a total of 35 countries. It's US patent count contributes only to 24.8% of its total global patent coverage. 11 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 Zolinza.

Family Patents

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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