REGADENOSON Drug Patent Profile
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When do Regadenoson patents expire, and what generic alternatives are available?
Regadenoson is a drug marketed by 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 thirteen NDAs.
The generic ingredient in REGADENOSON is regadenoson. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Regadenoson
A generic version of REGADENOSON was approved as regadenoson by ACCORD HLTHCARE on April 11th, 2022.
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Summary 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 |
Pharmacology for REGADENOSON
| Drug Class | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 213236-001 | Apr 11, 2022 | 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 | |||
| Dr Reddys | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 213210-001 | Apr 11, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 212806-001 | Apr 11, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 215827-001 | Feb 2, 2023 | 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 |
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 |
