Gadobutrol Patent Expiration

Gadobutrol is Used for enhancing images in magnetic resonance imaging procedures. It was first introduced by Bayer Healthcare Pharmaceuticals Inc in its drug Gadavist on Mar 14, 2011. 6 different companies have introduced drugs containing Gadobutrol.


Gadobutrol Patents

Given below is the list of patents protecting Gadobutrol, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Gadavist US5980864 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them Nov 09, 2021

(Expired)

Bayer Hlthcare
Gadavist US5980864 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them Nov 09, 2016

(Expired)

Bayer Hlthcare



Gadobutrol's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Gadobutrol:

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.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast National Institute of Neurological Disorders and Stroke (NINDS) NA NOT YET RECRUITING
(Aug 25, 2026)
PHASE1
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children Guerbet NA COMPLETED
(Jun 1, 2026)
PHASE3
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions Shanghai Shengdi Pharmaceutical Co., Ltd NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Novel Imaging Technique to Assess Gynecologic Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions Shanghai Shengdi Pharmaceutical Co., Ltd NA RECRUITING
(Apr 1, 2026)
PHASE3
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients GE Healthcare NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3


Gadobutrol Generic API Manufacturers

Several generic applications have been filed for Gadobutrol. The first generic version for Gadobutrol was by Jiangsu Hengrui Pharmaceuticals Co Ltd and was approved on Nov 17, 2022. And the latest generic version is by Ge Healthcare Inc and was approved on Jun 29, 2026.

Given below is the list of companies who have filed for Gadobutrol generic, along with the locations of their manufacturing plants worldwide.