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 two branded drugs marketed by Astellas, Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Ge Healthcare, Gland Pharma Ltd, Hikma, Hospira, Ims Ltd, Indies Pharma, Meitheal, and Mylan, and is included in fourteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regadenoson has twenty-eight patent family members in eighteen countries.

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

Summary for regadenoson

International Patents:	28
US Patents:	2
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	60
Patent Applications:	708
Drug Prices:	Drug price trends for regadenoson
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regadenoson
What excipients (inactive ingredients) are in regadenoson?	regadenoson excipients list
DailyMed Link:	regadenoson at DailyMed

See drug prices for regadenoson

Recent Clinical Trials for regadenoson

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
Emory University	N/A
Siemens Medical Solutions	N/A

See all regadenoson clinical trials

Pharmacology for regadenoson

Drug Class	Adenosine Receptor Agonist Pharmacologic Cardiac Stress Test Agent
Mechanism of Action	Adenosine Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for regadenoson

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for REGADENOSON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXISCAN	Injection	regadenoson	0.08 mg/mL, 5 mL vial	022161	1	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
Hospira	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	214349-001	Aug 31, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207604-001	Apr 11, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Indies Pharma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	218054-001	Aug 22, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207320-001	Jul 12, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213856-001	Apr 4, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213210-001	Apr 11, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for regadenoson

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GE Healthcare AS	Rapiscan	regadenoson	EMEA/H/C/001176 This medicinal product is for diagnostic use only.Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.	Authorised	no	no	no	2010-09-06
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for regadenoson

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Country	Patent Number	Title	Estimated Expiration
Portugal	1989214		⤷ Sign Up
Poland	1989214		⤷ Sign Up
New Zealand	570239	Preparation of (1-{ 9-[(4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl} pyrazol-4-yl)-N-methylcarboxamide monohydrate	⤷ Sign Up
Japan	2009525347		⤷ Sign Up
Japan	2013010791	PROCESS FOR PREPARING A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS	⤷ Sign Up
Israel	193153	תהליך להכנת אגוניסט לקולטן אדנוזין a2a (Process for preparing an a2a-adenosine receptor agonist)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for regadenoson

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	11C0004	France	⤷ Sign Up	PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	2011C/004	Belgium	⤷ Sign Up	PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1189916	2/2011	Austria	⤷ Sign Up	PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	CA 2011 00005	Denmark	⤷ Sign Up	PRODUCT NAME: REGADENOSON OG SALTE DERAF
1189916	C01189916/01	Switzerland	⤷ Sign Up	PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916	1190003-2.L	Sweden	⤷ Sign Up	PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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