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
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 |
Generic filers with tentative approvals for REGADENOSON
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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 | 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 |
International Patents for regadenoson
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1044952 | See Plans and Pricing | |
Norway | 20016350 | See Plans and Pricing | |
Portugal | 1189916 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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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