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JADENU Drug Profile
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When do Jadenu patents expire, and when can generic versions of Jadenu launch?
Jadenu is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and five patent family members in fifty countries.
The generic ingredient in JADENU is deferasirox. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
US ANDA Litigation and Generic Entry Outlook for Jadenu
A generic version of JADENU was approved as deferasirox by ACTAVIS ELIZABETH on January 25th, 2020.
Summary for JADENU
| International Patents: | 105 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 2 |
| Patent Applications: | 517 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JADENU |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JADENU |
| DailyMed Link: | JADENU at DailyMed |
Recent Clinical Trials for JADENU
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| DisperSol Technologies, LLC | Phase 2 |
| Novartis Pharmaceuticals | Phase 2 |
Recent Litigation for JADENU
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALEMBIC PHARMACEUTICALS, LTD v. NOVARTIS PHARMACEUTICALS CORP. | 2019-11-27 |
| Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. | 2016-07-29 |
| Novartis Pharmaceuticals Corporation v. Mylan Inc. | 2014-06-26 |
Pharmacology for JADENU
| Drug Class | Iron Chelator |
| Mechanism of Action | Iron Chelating Activity Cytochrome P450 3A4 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 1A2 Inhibitors |
Paragraph IV (Patent) Challenges for JADENU
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| JADENU | TABLET;ORAL | deferasirox | 206910 | 2016-04-21 |
| JADENU | TABLET;ORAL | deferasirox | 206910 | 2015-10-19 |
US Patents and Regulatory Information for JADENU
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-001 | Mar 30, 2015 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-003 | May 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-002 | Mar 30, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | Start Trial | Start Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-002 | Mar 30, 2015 | Start Trial | Start Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-001 | Mar 30, 2015 | Start Trial | Start Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JADENU
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cuba | 24348 | Start Trial |
| Croatia | P20190173 | Start Trial |
| Eurasian Patent Organization | 031719 | Start Trial |
| Serbia | 56890 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JADENU
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0914118 | SPC 035/2006 | Ireland | Start Trial | SPC 035/2006: 20070528, EXPIRES: 20210827 |
| 0914118 | 300248 | Netherlands | Start Trial | 300248, 20170624, EXPIRES: 20210827 |
| 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 | PA2007001 | Lithuania | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
