AMBELVIST Drug Patent Profile

Name: AMBELVIST Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Ambelvist patents expire, and what generic alternatives are available?

Ambelvist is a drug marketed by Bayer Healthcare and is included in one NDA. There are six patents protecting this drug.

The generic ingredient in AMBELVIST is gadoquatrane. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadoquatrane profile page.

DrugPatentWatch^® Generic Entry Outlook for Ambelvist

Ambelvist will be eligible for patent challenges on June 12, 2030. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 19, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AMBELVIST

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in AMBELVIST?	AMBELVIST excipients list
DailyMed Link:	AMBELVIST at DailyMed

Drug patent expirations by year for AMBELVIST

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMBELVIST

Generic Entry Date for AMBELVIST^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial NDA: 219627 Dosage: SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for AMBELVIST

AMBELVIST is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMBELVIST is ⤷ Start Trial.

This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-006	Jun 12, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial		Y		⤷ Start Trial
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-005	Jun 12, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-004	Jun 12, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-005	Jun 12, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for AMBELVIST

When does loss-of-exclusivity occur for AMBELVIST?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 19382881
Estimated Expiration: ⤷ Start Trial

Patent: 25226747
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 2021007707
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 20665
Estimated Expiration: ⤷ Start Trial

Chile

Patent: 21001331
Estimated Expiration: ⤷ Start Trial

Patent: 23003162
Estimated Expiration: ⤷ Start Trial

China

Patent: 3164628
Estimated Expiration: ⤷ Start Trial

Colombia

Patent: 21006034
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 83613
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 3281
Estimated Expiration: ⤷ Start Trial

Patent: 1215
Patent: פורמולציה של מדיה מנוגדת ותהליך להכנתה (Formulation of contrast media and process of preparation thereof)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 20007
Estimated Expiration: ⤷ Start Trial

Patent: 22508185
Patent: 造影剤の製剤およびその調製方法
Estimated Expiration: ⤷ Start Trial

Patent: 24133090
Patent: 造影剤の製剤およびその調製方法 (FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF)
Estimated Expiration: ⤷ Start Trial

Jordan

Patent: 0210114
Patent: تركيبة وسط تباين وعملية لتحضيرها (FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF)
Estimated Expiration: ⤷ Start Trial

Malaysia

Patent: 8484
Patent: FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 0196
Patent: FORMULACIÓN DE MEDIOS DE CONTRASTE Y PROCESO PARA PREPARARLOS. (FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF)
Estimated Expiration: ⤷ Start Trial

Patent: 21006024
Patent: FORMULACION DE MEDIOS DE CONTRASTE Y PROCESO PARA PREPARARLOS. (FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF.)
Estimated Expiration: ⤷ Start Trial

Peru

Patent: 211471
Patent: FORMULACION DE MEDIOS DE CONTRASTE Y PROCESO PARA PREPARARLOS
Estimated Expiration: ⤷ Start Trial

Singapore

Patent: 202104657R
Patent: FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 2934987
Estimated Expiration: ⤷ Start Trial

Patent: 210095168
Patent: 조영 매체의 제형 및 그의 제조 방법
Estimated Expiration: ⤷ Start Trial

Ukraine

Patent: 0195
Patent: СКЛАД КОНТРАСТНИХ ЗАСОБІВ І СПОСІБ ЙОГО ОДЕРЖАННЯ (FORMULATION OF CONTRAST MEDIA AND PROCESS OF PREPARATION THEREOF)
Estimated Expiration: ⤷ Start Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AMBELVIST around the world.

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Country	Patent Number	Title	Estimated Expiration
Argentina	104897		⤷ Start Trial
Australia	2016272602		⤷ Start Trial
Brazil	112017026135		⤷ Start Trial
Canada	2987993		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration