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EXJADE Drug Profile
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When do Exjade patents expire, and when can generic versions of Exjade launch?
Exjade is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty-eight patent family members in thirty-four countries.
The generic ingredient in EXJADE 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 Exjade
A generic version of EXJADE was approved as deferasirox by ACTAVIS ELIZABETH on January 24th, 2020.
Summary for EXJADE
| International Patents: | 48 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 29 |
| Patent Applications: | 517 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXJADE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXJADE |
| DailyMed Link: | EXJADE at DailyMed |
Recent Clinical Trials for EXJADE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fondazione Italiana Sindromi Mielodisplastiche Onlus | Phase 2 |
| DisperSol Technologies, LLC | Phase 2 |
| Abramson Cancer Center of the University of Pennsylvania | N/A |
Recent Litigation for EXJADE
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 EXJADE
| 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 EXJADE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXJADE | TABLET, FOR SUSPENSION;ORAL | deferasirox | 021882 | 2011-10-28 |
US Patents and Regulatory Information for EXJADE
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | |
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | AB | RX | Yes | Yes | 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 EXJADE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | Start Trial | Start Trial |
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | Start Trial | Start Trial |
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | Start Trial | Start Trial |
| Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXJADE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Georgia, Republic of | P20084355 | Start Trial |
| Denmark | 0914118 | Start Trial |
| Germany | 122007000020 | Start Trial |
| South Korea | 20000022222 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EXJADE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0914118 | CA 2006 00035 | Denmark | Start Trial | |
| 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 |
| 0914118 | C00914118/01 | Switzerland | Start Trial | PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005 |
| 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. |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
