REGADENOSON - Generic Drug Details
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What are the generic 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, 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: | 713 |
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 |
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 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 213856-001 | Apr 4, 2023 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Meitheal | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 212806-001 | Apr 11, 2022 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Apotex | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 207604-001 | Apr 11, 2022 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
>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 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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1127358 | 製備種 型腺苷受體激動劑及其多晶形物的方法 (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS A2A) | ⤷ Subscribe |
Spain | 2593028 | ⤷ Subscribe | |
South Korea | 101494125 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REGADENOSON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1189916 | 11C0004 | France | ⤷ Subscribe | PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
1189916 | SPC/GB11/005 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906 |
1189916 | C300477 | Netherlands | ⤷ Subscribe | 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 |
REGADENOSON Market Analysis and Financial Projection Experimental
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