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Deferasirox - Generic Drug Details
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What are the generic drug sources for deferasirox and what is the scope of patent protection?
Deferasirox
is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Novartis, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Ichnos, MSN, Sun Pharm, Zydus Pharms, Amneal, Cipla, Piramal Hlthcare Uk, Teva Pharms Usa, and Novartis Pharms Corp, and is included in twenty-two NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Deferasirox has sixty-three patent family members in thirty-eight countries.
There are twenty drug master file entries for deferasirox. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for deferasirox
International Patents: | 63 |
US Patents: | 1 |
Tradenames: | 4 |
Applicants: | 14 |
NDAs: | 22 |
Drug Master File Entries: | 20 |
Suppliers / Packagers: | 17 |
Bulk Api Vendors: | 112 |
Clinical Trials: | 87 |
Patent Applications: | 1,944 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for deferasirox |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for deferasirox |
What excipients (inactive ingredients) are in deferasirox? | deferasirox excipients list |
DailyMed Link: | deferasirox at DailyMed |
Recent Clinical Trials for deferasirox
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fondazione Italiana Sindromi Mielodisplastiche Onlus | Phase 2 |
DisperSol Technologies, LLC | Phase 2 |
Fred Hutchinson Cancer Research Center | Phase 2 |
Generic filers with tentative approvals for DEFERASIROX
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 500MG | TABLET, FOR SUSPENSION;ORAL |
Start Trial | Start Trial | 250MG | TABLET, FOR SUSPENSION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for deferasirox
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 DEFERASIROX
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
JADENU | TABLET;ORAL | deferasirox | 206910 | 2016-04-21 |
JADENU | TABLET;ORAL | deferasirox | 206910 | 2015-10-19 |
EXJADE | TABLET, FOR SUSPENSION;ORAL | deferasirox | 021882 | 2011-10-28 |
US Patents and Regulatory Information for deferasirox
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 | Start Trial | |||
Zydus Pharms | DEFERASIROX | deferasirox | TABLET;ORAL | 211383-001 | Nov 20, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Bionpharma Inc | DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 210920-001 | Nov 20, 2019 | AB | RX | No | 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 | |||
>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 deferasirox
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 | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | 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 | 206910-001 | Mar 30, 2015 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for deferasirox
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 2964202 | Start Trial |
Japan | 6434429 | Start Trial |
World Intellectual Property Organization (WIPO) | 2014136079 | Start Trial |
Eurasian Patent Organization | 031719 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for deferasirox
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 | 06C0049 | France | Start Trial | 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 | PA2007001,C0914118 | 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 |
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