FERRIPROX Drug Patent Profile
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Which patents cover Ferriprox, and when can generic versions of Ferriprox launch?
Ferriprox is a drug marketed by Chiesi and is included in three NDAs. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in twenty-eight countries.
The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ferriprox
A generic version of FERRIPROX was approved as deferiprone by TARO on February 8th, 2019.
Summary for FERRIPROX
| International Patents: | 44 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 123 |
| Clinical Trials: | 26 |
| Patent Applications: | 1,806 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FERRIPROX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FERRIPROX |
| What excipients (inactive ingredients) are in FERRIPROX? | FERRIPROX excipients list |
| DailyMed Link: | FERRIPROX at DailyMed |
Recent Clinical Trials for FERRIPROX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chiesi Canada Corp | Phase 4 |
| Hadassah Medical Organization | Phase 2/Phase 3 |
| SocraTec R&D GmbH | Phase 1 |
Pharmacology for FERRIPROX
| Drug Class | Iron Chelator |
| Mechanism of Action | Iron Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for FERRIPROX
Paragraph IV (Patent) Challenges for FERRIPROX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FERRIPROX | Tablets | deferiprone | 500 mg | 021825 | 1 | 2016-01-29 |
US Patents and Regulatory Information for FERRIPROX
FERRIPROX is protected by six US patents and six FDA Regulatory Exclusivities.
Patents protecting FERRIPROX
Delayed release deferiprone tablets and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
Delayed release deferiprone tablets and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
Delayed release deferiprone tablets and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Delayed release deferiprone tablets and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid formulation for deferiprone with palatable taste
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
FDA Regulatory Exclusivity protecting FERRIPROX
TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES
Exclusivity 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-002 | Apr 20, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 212269-001 | May 19, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-001 | Oct 14, 2011 | AB | RX | Yes | No | ⤷ 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 FERRIPROX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-002 | Apr 20, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-001 | Oct 14, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-002 | Jul 25, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FERRIPROX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Chiesi Farmaceutici S.p.A. | Ferriprox | deferiprone | EMEA/H/C/000236 Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction. |
Authorised | no | no | no | 1999-08-25 | |
| Lipomed GmbH | Deferiprone Lipomed | deferiprone | EMEA/H/C/004710 Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Deferiprone Lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction. |
Authorised | yes | no | no | 2018-09-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FERRIPROX
See the table below for patents covering FERRIPROX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2020004107 | TABLETAS DE DEFERIPRONA DE LIBERACION RETRASADA Y METODOS DE USO DE LAS MISMAS. (DELAYED RELEASE DEFERIPRONE TABLETS AND METHODS OF USING THE SAME.) | ⤷ Try a Trial |
| Australia | 2008355464 | Liquid formulation for deferiprone with palatable taste | ⤷ Try a Trial |
| Brazil | 112020008128 | comprimidos de liberação retardada de deferiprona e métodos para utilização dos mesmos | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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