Gadavist is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2016 out of which all have expired. Gadavist's patents have been open to challenges since 15 March, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 12, 2022. Details of Gadavist'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. | |||
| US5980864 | 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them |
Nov, 2021
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5980864 | 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them |
Nov, 2016
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Gadavist. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Gadavist, 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
Gadavist.
Exclusivity Information
Gadavist holds 4 exclusivities. All of its exclusivities have expired in 2022. Details of Gadavist's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 14, 2016 |
| New Indication(I-688) | Jun 11, 2017 |
| New Indication(I-731) | Apr 27, 2019 |
| New Indication(I-801) | Jul 12, 2022 |
US patents provide insights into the exclusivity only within the United States, but
Gadavist 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 Gadavist's family patents as well as insights into
ongoing legal events
on those patents.
Gadavist's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Gadavist:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Gadavist's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 12, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gadavist Generic API suppliers:
Gadobutrol is the generic name for the brand Gadavist. 5 different companies have already filed for the generic of Gadavist, with Hengrui Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gadavist's generic
About Gadavist
Gadavist is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for enhancing images in magnetic resonance imaging procedures. Gadavist uses Gadobutrol as an active ingredient. Gadavist was launched by Bayer in 2013.
Approval Date:
Gadavist was approved by FDA for market use on 18 December, 2013.
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 Gadavist is 18 December, 2013, its NCE-1 date is estimated to be 15 March, 2015.
Active Ingredient:
Gadavist uses Gadobutrol as the active ingredient. Check out other Drugs and Companies using Gadobutrol ingredient
Treatment:
Gadavist is used for enhancing images in magnetic resonance imaging procedures.
Dosage:
Gadavist is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.20944GM/2ML (604.72MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 9.0708GM/15ML (604.72MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 18.1416GM/30ML (604.72MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 6.0472GM/10ML (604.72MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 39.3068GM/65ML (604.72MG/ML) | SOLUTION | Prescription | INTRAVENOUS |