Regadenoson - Generic Drug Details

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

Regadenoson is the generic ingredient in two branded drugs marketed by Astellas, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Ims Ltd, and Meitheal, and is included in nine NDAs. 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. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for regadenoson

International Patents:	58
US Patents:	3
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	60
Patent Applications:	1,189
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

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

Generic filers with tentative approvals for REGADENOSON

Applicant	Application No.	Strength	Dosage Form
		0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for regadenoson

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

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

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	AP	RX	Yes	Yes			Y
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes			Y	Y
Eugia Pharma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	216437-001	Oct 26, 2022	AP	RX	No	No

Expired US Patents for regadenoson

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

EU/EMA Drug Approvals for regadenoson

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

International Patents for regadenoson

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1044952
Norway	20016350
Portugal	1189916

Supplementary Protection Certificates for regadenoson

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	C01189916/01	Switzerland		PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916	91785	Luxembourg		91785, EXPIRES: 20250621
1189916	C300477	Netherlands		PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906