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Generated: August 23, 2017
What are the generic sources for deferasirox and what is the scope of deferasirox freedom to operate?
Deferasirox is the generic ingredient in four branded drugs marketed by Novartis Pharms Corp, Actavis Elizabeth, and Novartis, and is included in four NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 3 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: see list | 20 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 71 |
| Clinical Trials: see list | 85 |
| Patent Applications: see list | 575 |
| Therapeutic Class: | Antidotes, Deterrents, and Toxicologic Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | deferasirox at DailyMed |
| Drug Class | Iron Chelator |
| Mechanism of Action | Iron Chelating Activity Cytochrome P450 3A4 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 1A2 Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | |||||||||||||||
Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-001 | Mar 30, 2015 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Novartis Pharms Corp | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-001 | Mar 30, 2015 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-002 | Mar 30, 2015 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,723,742 | Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2890465 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 3262997 | ► Subscribe | |||||||||||||||||||||||||||
| Bulgaria | 64248 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2964202 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 0914118 | ► 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.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 2007001 | Lithuania | ► Subscribe | PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006 08 28, EU/1/06/356/002 2006 08 28, EU/1/06/356/003 2006 08 28, EU/1/06/356/004 2006 08 28, EU/1/06/356/005 2006 08 28, EU/1/06/356/00 20060828 | ||||||||||||||||||||||||||
| 2006 00035 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| C/GB07/002 | United Kingdom | ► Subscribe | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021. | ||||||||||||||||||||||||||
| 0914118/01 | Switzerland | ► Subscribe | PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005 | ||||||||||||||||||||||||||
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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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