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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. 3 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.

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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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 Hainan Poly Pharmaceutical Co Ltd and was approved on Apr 16, 2025.

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


1. HAINAN POLY PHARM

Hainan Poly Pharmaceutical Co Ltd has filed for 6 different strengths of generic version for Gadobutrol. Given below are the details of the strengths of this generic introduced by Hainan Poly Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
9.0708GM/15ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Mar 15, 2023
4.5354GM/7.5ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Mar 15, 2023
1.20944GM/2ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Apr 16, 2025
6.0472GM/10ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Apr 16, 2025
18.1416GM/30ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Apr 16, 2025
39.3068GM/65ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Apr 16, 2025


Manufacturing Plant Locations
New

Hainan Poly Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Hainan Poly Pharm as present at those locations.

Country City Firm Name
China
Haikou Hainan Poly Pharm. Co., Ltd.





2. HENGRUI PHARMA

Jiangsu Hengrui Pharmaceuticals Co Ltd has filed for 6 different strengths of generic version for Gadobutrol. Given below are the details of the strengths of this generic introduced by Hengrui Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
9.0708GM/15ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Nov 17, 2022
1.20944GM/2ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Nov 17, 2022
4.5354GM/7.5ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Nov 17, 2022
6.0472GM/10ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Nov 17, 2022
39.3068GM/65ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Sep 8, 2023
18.1416GM/30ML (604.72MG/ML)

solution Prescription INTRAVENOUS AP Sep 8, 2023