JADENU Drug Patent Profile
✉ Email this page to a colleague
When do Jadenu patents expire, and what generic alternatives are available?
Jadenu is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has sixty-seven patent family members in forty-two countries.
The generic ingredient in JADENU is deferasirox. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Jadenu
A generic version of JADENU was approved as deferasirox by ACTAVIS ELIZABETH on January 26th, 2016.
Summary for JADENU
| International Patents: | 67 |
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 143 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,373 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JADENU |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JADENU |
| What excipients (inactive ingredients) are in JADENU? | JADENU excipients list |
| 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 |
Pharmacology for JADENU
| Drug Class | Iron Chelator |
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for JADENU
Paragraph IV (Patent) Challenges for JADENU
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JADENU | Tablets | deferasirox | 180 mg | 206910 | 1 | 2016-04-21 |
| JADENU | Tablets | deferasirox | 90 mg and 360 mg | 206910 | 1 | 2015-10-19 |
US Patents and Regulatory Information for JADENU
JADENU is protected by one US patents.
Patents protecting JADENU
Oral formulations of deferasirox
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-001 | May 18, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-002 | Mar 30, 2015 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| Novartis | JADENU SPRINKLE | deferasirox | GRANULE;ORAL | 207968-003 | May 18, 2017 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 206910-002 | Mar 30, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-002 | Mar 30, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-001 | Mar 30, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis Pharms Corp | JADENU | deferasirox | TABLET;ORAL | 206910-003 | Mar 30, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for JADENU
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Limited | Deferasirox Mylan | deferasirox | EMEA/H/C/005014 Deferasirox Mylan is indicated forthe treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and olderthe treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions ( |
Authorised | yes | no | no | 2019-09-26 | |
| Novartis Europharm Limited | Exjade | deferasirox | EMEA/H/C/000670 Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;in patients with other anaemias aged two years and older.Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older. |
Authorised | no | no | no | 2006-08-28 | |
| Accord Healthcare S.L.U. | Deferasirox Accord | deferasirox | EMEA/H/C/005156 Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions ( |
Authorised | yes | no | no | 2020-01-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for JADENU
See the table below for patents covering JADENU around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Serbia | 56890 | FORMULACIJE DEFERASIROKSA ZA ORALNU UPOTREBU (ORAL FORMULATIONS OF DEFERASIROX) | ⤷ Try a Trial |
| Ecuador | SP15042897 | FORMULACIONES ORALES DE DEFERASIROX | ⤷ Try a Trial |
| Japan | 2020180123 | デフェラシロクスの経口製剤 (ORAL FORMULATIONS OF DEFERASIROX) | ⤷ Try a Trial |
| Nicaragua | 201500126 | FORMULACIONES ORALES DE DEFERASIROX | ⤷ Try a Trial |
| Taiwan | I625136 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JADENU
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0914118 | SPC 035/2006 | Ireland | ⤷ Try a Trial | SPC 035/2006: 20070528, EXPIRES: 20210827 |
| 0914118 | 300248 | Netherlands | ⤷ Try a Trial | 300248, 20170624, EXPIRES: 20210827 |
| 0914118 | CA 2006 00035 | Denmark | ⤷ Try a Trial | |
| 0914118 | 290 | Finland | ⤷ Try a Trial | |
| 0914118 | 06C0049 | France | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
