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JADENU SPRINKLE Drug Profile
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When do Jadenu Sprinkle patents expire, and when can generic versions of Jadenu Sprinkle launch?
Jadenu Sprinkle is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in JADENU SPRINKLE is deferasirox. There are twenty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
US ANDA Litigation and Generic Entry Outlook for Jadenu Sprinkle
A generic version of JADENU SPRINKLE was approved as deferasirox by ACTAVIS ELIZABETH on January 26th, 2016.
Summary for JADENU SPRINKLE
Pharmacology for JADENU SPRINKLE
| Drug Class | Iron Chelator |
| Mechanism of Action | Iron Chelating Activity Cytochrome P450 3A4 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 1A2 Inhibitors |
US Patents and Regulatory Information for JADENU SPRINKLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-003 | May 18, 2017 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-002 | May 18, 2017 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| >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 JADENU SPRINKLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | Start Trial | Start Trial |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-002 | May 18, 2017 | Start Trial | Start Trial |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-003 | May 18, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JADENU SPRINKLE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Bulgaria | 64248 | Start Trial |
| Spain | 2187785 | Start Trial |
| South Korea | 100616378 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JADENU SPRINKLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0914118 | SPC/GB07/002 | United Kingdom | Start Trial | 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 | C00914118/01 | Switzerland | Start Trial | PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005 |
| 0914118 | CA 2006 00035 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
