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Last Updated: October 26, 2020

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Regadenoson - Generic Drug Details

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What are the generic drug sources for regadenoson and what is the scope of patent protection?

Regadenoson is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regadenoson has fifty-eight patent family members in twenty-six countries.

There are nine drug master file entries for regadenoson. Two suppliers are listed for this compound.

Summary for regadenoson

International Patents:	58
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	2
Bulk Api Vendors:	50
Clinical Trials:	55
Patent Applications:	414
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regadenoson
DailyMed Link:	regadenoson at DailyMed

Recent Clinical Trials for regadenoson

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Maryland, Baltimore	Early Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1
Emory University	N/A

See all regadenoson clinical trials

Pharmacology for regadenoson

Drug Class	Adenosine Receptor Agonist
Mechanism of Action	Adenosine Receptor Agonists

Paragraph IV (Patent) Challenges for REGADENOSON

Tradename	Dosage	Ingredient	NDA	Submissiondate
LEXISCAN	SOLUTION;INTRAVENOUS	regadenoson	022161	2012-04-10

US Patents and Regulatory Information for regadenoson

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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
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	Start Trial	Start Trial	Y	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

Expired US Patents for regadenoson

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	Start Trial	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	Start Trial	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	Start Trial	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	Start Trial	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for regadenoson

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Country	Patent Number	Estimated Expiration
China	102260311	Start Trial
World Intellectual Property Organization (WIPO)	0078779	Start Trial
South Africa	200200301	Start Trial
Turkey	200200588	Start Trial
Australia	7132400	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for regadenoson

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	91785	Luxembourg	Start Trial	91785, EXPIRES: 20250621
1189916	C01189916/01	Switzerland	Start Trial	PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916	SPC/GB11/005	United Kingdom	Start Trial	PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
1189916	392	Finland	Start Trial
1189916	122011000010	Germany	Start Trial	PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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