JADENU SPRINKLE Drug Patent 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.
DrugPatentWatch® 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
Anatomical Therapeutic Chemical (ATC) Classes for JADENU SPRINKLE
US Patents and Regulatory Information for JADENU SPRINKLE
JADENU SPRINKLE is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting JADENU SPRINKLE
INFORMATION ADDED TO THE LABELING FOR SAFETY & EFFICACY STUDY ENTITLED, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL OF DEFERASIROX IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (LOW/INT-1 RISK) & TRANSFUSIONAL IRON OVERLOAD
Exclusivity Expiration: See Plans and Pricing
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-002 | May 18, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 | 207968-002 | May 18, 2017 | See Plans and Pricing | See Plans and Pricing |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | See Plans and Pricing | See Plans and Pricing |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-003 | May 18, 2017 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JADENU SPRINKLE
See the table below for patents covering JADENU SPRINKLE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 226232 | SUBSTITUTED 3,5-DIPHENYL-1,2,4-TRIAZOLES, THEIR PRODUCTION PROCESSES, THEIR USE AS PHARMACEUTICAL METAL CHELATORS AND PHARAMCEUTICAL COMPOSITIONS COMPRISING SAID COMPOSITIONS | See Plans and Pricing |
| Hong Kong | 1020530 | See Plans and Pricing | |
| Austria | 226435 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JADENU SPRINKLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0914118 | 06C0049 | France | See Plans and Pricing | PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828 |
| 0914118 | SPC 035/2006 | Ireland | See Plans and Pricing | SPC 035/2006: 20070528, EXPIRES: 20210827 |
| 0914118 | 300248 | Netherlands | See Plans and Pricing | 300248, 20170624, EXPIRES: 20210827 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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