Vistogard Patent Expiration

Vistogard is a drug owned by Btg International Inc. It is protected by 3 US drug patents filed in 2015. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 17, 2027. Details of Vistogard's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5968914 Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Oct, 2016

(7 years ago)

Expired
US6258795 Acylated uridine and cytidine and uses thereof
Jul, 2023

(1 year, 9 days ago)

Expired
US7776838 Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Aug, 2027

(3 years from now)

Active


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vistogard and ongoing litigations to help you estimate the early arrival of Vistogard generic.

Vistogard's Litigations

Vistogard has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 16, 2002, against patent number US7776838. The petitioner , challenged the validity or infringement of this patent, with VON BORSTEL et al as the respondent. Click below to track the latest information on how companies are challenging Vistogard's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7776838 April, 2002 Decision VON BORSTEL et al


FDA has granted some exclusivities to Vistogard. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vistogard, 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 Vistogard.

Exclusivity Information

Vistogard holds 4 exclusivities. All of its exclusivities have expired in 2022. Details of Vistogard's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Dec 11, 2018
New Chemical Entity Exclusivity(NCE) Sep 04, 2020
Orphan Drug Exclusivity(ODE-104) Dec 11, 2022
Orphan Drug Exclusivity(ODE) Dec 11, 2022

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US patents provide insights into the exclusivity only within the United States, but Vistogard 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 Vistogard's family patents as well as insights into ongoing legal events on those patents.

Vistogard's family patents


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Generic Launch

Generic Release Date:

Vistogard's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 17, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Vistogard Generics:

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





About Vistogard

Vistogard is a drug owned by Btg International Inc. It is used for emergency treatment of severe cardiac or CNS toxicity following fluorouracil or capecitabine overdose. Vistogard uses Uridine Triacetate as an active ingredient. Vistogard was launched by Btg Intl in 2015.

Market Authorisation Date:

Vistogard was approved by FDA for market use on 11 December, 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 Vistogard is 11 December, 2015, its NCE-1 date is estimated to be 05 September, 2019

Active Ingredient:

Vistogard uses Uridine Triacetate as the active ingredient. Check out other Drugs and Companies using Uridine Triacetate ingredient

Treatment:

Vistogard is used for emergency treatment of severe cardiac or CNS toxicity following fluorouracil or capecitabine overdose.

Dosage:

Vistogard is available in granule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10GM/PACKET GRANULE Prescription ORAL