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Last Updated: January 30, 2023

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 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
Recent Clinical Trials for regadenoson

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

SponsorPhase
St. Jude Children's Research HospitalPhase 2
Emory UniversityN/A
Siemens Medical SolutionsN/A

See all regadenoson clinical trials

Generic filers with tentative approvals for REGADENOSON
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.4MG/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.

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

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

EU/EMA Drug Approvals for regadenoson

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GE Healthcare ASĀ  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

Supplementary Protection Certificates for regadenoson

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

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Johnson and Johnson
Merck
Express Scripts
AstraZeneca

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