Eovist is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Eovist's patents have been open to challenges since 03 July, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 13, 2021. Details of Eovist'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). | |||
| US6039931 | Derivatized DTPA complexes, pharmaceutical agents containing these compounds, their use, and processes for their production |
Nov, 2021
(3 years ago) |
Expired
|
| US5798092 | Derivatized DTPA complexes pharmaceutical agents containing these compounds, their use, and processes for their production |
Aug, 2015
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Eovist. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Eovist, 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 Eovist.
Exclusivity Information
Eovist holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Eovist's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 03, 2013 |
| M(M-155) | Mar 27, 2018 |
US patents provide insights into the exclusivity only within the United States, but Eovist 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 Eovist's family patents as well as insights into ongoing legal events on those patents.
Eovist's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Eovist's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 13, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Eovist Generics:
There are no approved generic versions for Eovist as of now.
About Eovist
Eovist is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for imaging the liver using magnetic resonance technology. Eovist uses Gadoxetate Disodium as an active ingredient. Eovist was launched by Bayer Hlthcare in 2008.
Approval Date:
Eovist was approved by FDA for market use on 03 July, 2008.
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 Eovist is 03 July, 2008, its NCE-1 date is estimated to be 03 July, 2012.
Active Ingredient:
Eovist uses Gadoxetate Disodium as the active ingredient. Check out other Drugs and Companies using Gadoxetate Disodium ingredient
Treatment:
Eovist is used for imaging the liver using magnetic resonance technology.
Dosage:
Eovist is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.72145GM/15ML (181.43MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 1.8143GM/10ML (181.43MG/ML) | SOLUTION | Prescription | INTRAVENOUS |