Regadenoson - Generic Drug Details

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What are the generic drug sources for regadenoson and what is the scope of freedom to operate?

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

Regadenoson has eighty-seven patent family members in twenty-seven countries.

There are nine drug master file entries for regadenoson. One supplier is listed for this compound.

Summary for regadenoson

International Patents:	87
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	46
Clinical Trials:	53
Patent Applications:	86
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
National Cancer Institute (NCI)	Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 1
Christine Lau, MD	Phase 1

See all regadenoson clinical trials

Recent Litigation for regadenoson

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Astellas US LLC v. Accord Healthcare, Inc.	2019-06-25
Astellas US LLC v. Sandoz Inc.	2018-10-25

See all regadenoson litigation

Pharmacology for regadenoson

Drug Class	Adenosine Receptor Agonist
Mechanism of Action	Adenosine Receptor Agonists

Synonyms for regadenoson

(1-(9-(3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl)-6-aminopurin-2-yl)pyrazol-4-yl)-N-methylcarboxamide
(1-{9-[(4s,2r,3r,5r)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl}pyrazol-4-yl)-n-methylcarboxamide
1-(6-Amino-9-beta-D-ribofuranosyl-9H-purin-2-yl)-N-methyl-1H-pyrazole-4-carboxamide
1-[6-Amino-9-((2R,3R,4S,5R)-3,4-dihydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-9H-purin-2-yl]-1H-pyrazole-4-carboxylic acid methylamide
1-[6-amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]purin-2-yl]-N-methylpyrazole-4-carboxamide
1-[6-amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]purin-2-yl]-N-methyl-pyrazole-4-carboxamide
1-{6-amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-9H-purin-2-yl}-N-methyl-1H-pyrazole-4-carboxamide
2-[4-(methylcarbamoyl)-1h-pyrazol-1-yl]adenosine
2-[4-[(Methylamino)carbonyl]-1H-pyrazol-1-yl]adenosine
313348-27-5
348R275
6-Amino-2-[4-(methylcarbamoyl)-1H-pyrazol-1-yl]purine-9-yl-beta-D-ribofuranoside;1-(6-amino-9-((2S,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yloxy)-9H-purin-2-yl)-N-methyl-1H-pyrazole-4-carboxamide
7AXV542LZ4
AC1L55X1
AC1Q5LB1
Adenosine, 2-(4-((methylamino)carbonyl)-1H-pyrazol-1-yl)-
Adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-
Adenosine,2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-
AKOS026750593
AOB6869
API0000807
AT-36942
B5904
BDBM50119132
CAS-313348-27-5
CHEBI:135613
CHEMBL317052
CS-5612
CTK4G6871
CV-3146
CVT 3146
CVT-3146
CVT-3146;CVT3146;CVT 3146
D05711
DB06213
DSSTox_CID_31501
DSSTox_GSID_57712
DSSTox_RID_97386
DTXSID4057712
EX-A2148
FT-0674337
GTPL5596
HY-A0168
J-018384
Lexiscan
Lexiscan (TN)
LS-193008
LZPZPHGJDAGEJZ-AKAIJSEGSA-N
MolPort-006-170-140
NCGC00249892-01
Rapiscan
Regadenoson (USAN/INN)
Regadenoson [USAN:INN]
Regadenoson anhydrous
Regadenoson; CVT-3146
SCHEMBL678893
Tox21_113668
UNII-7AXV542LZ4
ZINC13818943

Paragraph IV (Patent) Challenges for REGADENOSON

Tradename	Dosage	Ingredient	NDA	Submissiondate
LEXISCAN	SOLUTION;INTRAVENOUS	regadenoson	022161

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	Y	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	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
>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
World Intellectual Property Organization (WIPO)	0078779	Start Trial
European Patent Office	1989214	Start Trial
Belgium	2011C004	Start Trial
Canada	2583185	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	SZ 2/2011	Austria	Start Trial	PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916	122011000010	Germany	Start Trial	PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	11C0004	France	Start Trial	PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	SPC004/2011	Ireland	Start Trial	SPC004/2011: 20110719, EXPIRES: 20250620
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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