DEFERIPRONE Drug Patent Profile
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Which patents cover Deferiprone, and what generic alternatives are available?
Deferiprone is a drug marketed by Hikma and Taro and is included in two NDAs.
The generic ingredient in DEFERIPRONE is deferiprone. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Deferiprone
A generic version of DEFERIPRONE was approved as deferiprone by TARO on February 8th, 2019.
Summary for DEFERIPRONE
Recent Clinical Trials for DEFERIPRONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 1 |
| Rohan Dharmakumar | Phase 1 |
| Lipomed AG | Phase 1 |
Pharmacology for DEFERIPRONE
| Drug Class | Iron Chelator |
| Mechanism of Action | Iron Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for DEFERIPRONE
Paragraph IV (Patent) Challenges for DEFERIPRONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FERRIPROX | Tablets | deferiprone | 500 mg | 021825 | 1 | 2016-01-29 |
US Patents and Regulatory Information for DEFERIPRONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | DEFERIPRONE | deferiprone | TABLET;ORAL | 213239-002 | Feb 8, 2022 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Taro | DEFERIPRONE | deferiprone | TABLET;ORAL | 208800-001 | Feb 8, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | DEFERIPRONE | deferiprone | TABLET;ORAL | 213239-001 | Mar 29, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Taro | DEFERIPRONE | deferiprone | TABLET;ORAL | 208800-002 | Nov 22, 2023 | AB | RX | No | 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 |
EU/EMA Drug Approvals for DEFERIPRONE
| 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 |
