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Generated: August 20, 2017
What is the patent landscape for Afinitor, and when can generic versions of Afinitor launch?
Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are nine patents protecting this drug and three Paragraph IV challenges.| Patents: | 8 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 15 |
| Clinical Trials: see list | 146 |
| Patent Applications: see list | 7,807 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | AFINITOR at DailyMed |
| Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| everolimus | Tablets for Oral Suspension | 2 mg, 3 mg and 5 mg | Afinitor Disperz | 12/30/2016 |
| everolimus | Tablets | 2.5 mg, 5 mg, and 7.5 mg | Afinitor | 12/10/2014 |
| everolimus | Tablets | 10 mg | Afinitor | 6/18/2014 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,605,613 | Macrolides | ► Subscribe | |||||||||||||||||||||||||||
| 7,572,804 | Macrolides | ► Subscribe | |||||||||||||||||||||||||||
| 6,852,729 | Macrolides | ► Subscribe | |||||||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Czech Republic | 303006 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20140708 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2275103 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 0609912 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2288033 | ► 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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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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