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. Vistogard's patents have been open to challenges since 05 September, 2019. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7776838 | Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides |
Aug, 2027
(2 years from now) | Active |
| US6258795 | Acylated uridine and cytidine and uses thereof |
Jul, 2023
(1 year, 9 months ago) |
Expired
|
| US5968914 | Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides |
Oct, 2016
(8 years ago) |
Expired
|
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 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 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 |
|---|---|---|---|---|
 | ||||
| US7776838 | April, 2002 |
Decision
(30 Apr, 2002) | 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) | Dec 11, 2022 |
| Orphan Drug Exclusivity(ODE-104) | Dec 11, 2022 |
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
Explore Our Curated Drug Screens
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.
Alternative Brands for Vistogard
Vistogard which is used for emergency treatment of severe cardiac or CNS toxicity following fluorouracil or capecitabine overdose., has several other brand drugs using the same active ingredient (Uridine Triacetate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Btg Intl |
|
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.
Approval Date:
Vistogard was approved by FDA for market use on 11 December, 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 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 |