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Generated: September 22, 2017
What are the generic drug sources for regadenoson and what is the scope of regadenoson freedom to operate?
Regadenoson is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 25 |
| Clinical Trials: see list | 49 |
| Patent Applications: see list | 76 |
| Drug Prices: | see low prices |
| DailyMed Link: | regadenoson at DailyMed |
| Drug Class | Adenosine Receptor Agonist |
| Mechanism of Action | Adenosine Receptor Agonists |
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,071,566 | Methods of coronary imaging | ► Subscribe | |||||||||||||||||||||||||||
| 8,278,435 | N-pyrazole A2A receptor agonists | ► Subscribe | |||||||||||||||||||||||||||
| 7,956,179 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||||||||||||||||
| 7,732,595 | Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||||||||||||||||
| 7,671,192 | Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||||||||||||||||
| 8,906,878 | Myocardial perfusion imaging methods and compositions | ► Subscribe | |||||||||||||||||||||||||||
| 9,163,057 | Methods of myocardial perfusion imaging | ► Subscribe | |||||||||||||||||||||||||||
| 8,569,260 | N-pyrazole A.sub.2A receptor agonists | ► Subscribe | |||||||||||||||||||||||||||
| 8,524,883 | Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide | ► Subscribe | |||||||||||||||||||||||||||
| 8,268,988 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 20016350 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 1989214 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2447081 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1189916 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2004011010 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 200500855 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | I230161 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 100463300 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 147198 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 193153 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0004 | France | ► Subscribe | PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| 00477 | Netherlands | ► Subscribe | PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| C/GB11/005 | United Kingdom | ► Subscribe | PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| 2011000010 | Germany | ► Subscribe | PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| 785 | Luxembourg | ► Subscribe | 91785, EXPIRES: 20250621 | ||||||||||||||||||||||||||
| 2011 | Austria | ► Subscribe | PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| 2 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 2011 00005 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| C004/2011 | Ireland | ► Subscribe | SPC004/2011: 20110719, EXPIRES: 20250620 | ||||||||||||||||||||||||||
| 90003-2.L | Sweden | ► Subscribe | PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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