Ambelvist is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 6 US drug patents filed in 2026 out of which none have expired yet. Ambelvist's patents will be open to challenges from 12 June, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be May 19, 2040. Details of Ambelvist'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. | |||
| US10137209 | Gadolinium Chelate Compounds For Use In Magnetic Resonance Imaging |
May, 2036
(9 years from now) | Active |
| US12478696 | Gadolinium Chelate Compounds For Use In Magnetic Resonance Imaging |
May, 2036
(9 years from now) | Active |
| US11491245 | Gadolinium Chelate Compounds For Use In Magnetic Resonance Imaging |
May, 2036
(9 years from now) | Active |
| US10722601 | Gadolinium Chelate Compounds For Use In Magnetic Resonance Imaging |
May, 2036
(9 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). | |||
| US11944690 | Formulation Of Contrast Media And Process Of Preparation Thereof |
May, 2040
(13 years from now) | Active |
| US12303573 | Formulation Of Contrast Media And Process Of Preparation Thereof |
Nov, 2039
(13 years from now) | Active |
FDA has granted several exclusivities to Ambelvist. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ambelvist, 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
Ambelvist.
Exclusivity Information
Ambelvist holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Ambelvist's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 12, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Ambelvist 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 Ambelvist's family patents as well as insights into
ongoing legal events
on those patents.
Ambelvist's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ambelvist's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ambelvist Generics:
There are no approved generic versions for Ambelvist as of now.
Alternative Brands for Ambelvist
There are several other brand drugs in the same treatment category as Ambelvist. 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 | Treatment Area | ||
|---|---|---|---|---|
| Guerbet |
| |||
About Ambelvist
Ambelvist is a drug owned by Bayer Healthcare Pharmaceuticals Inc. Ambelvist uses Gadoquatrane as an active ingredient. Ambelvist was launched by Bayer in 2026.
Approval Date:
Ambelvist was approved by FDA for market use on 12 June, 2026.
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 Ambelvist is 12 June, 2026, its NCE-1 date is estimated to be 12 June, 2030.
Active Ingredient:
Ambelvist uses Gadoquatrane as the active ingredient. Check out other Drugs and Companies using Gadoquatrane ingredient
Dosage:
Ambelvist is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5158GM/2ML (257.9MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 16.7635GM/65ML (257.9MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 1.93425GM/7.5ML (257.9MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 2.579GM/10ML (257.9MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 7.737GM/30ML (257.9MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 3.8685GM/15ML (257.9MG/ML) | SOLUTION | Prescription | INTRAVENOUS |