DEFERIPRONE - Generic Drug Details
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What are the generic drug sources for deferiprone and what is the scope of patent protection?
Deferiprone
is the generic ingredient in two branded drugs marketed by Chiesi, Hikma, and Taro, and is included in five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Deferiprone has forty-six patent family members in twenty-eight countries.
There are four drug master file entries for deferiprone. Three suppliers are listed for this compound.
Summary for DEFERIPRONE
International Patents: | 46 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 5 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 63 |
Patent Applications: | 2,677 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for DEFERIPRONE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEFERIPRONE |
What excipients (inactive ingredients) are in DEFERIPRONE? | DEFERIPRONE excipients list |
DailyMed Link: | DEFERIPRONE at DailyMed |
Recent Clinical Trials for DEFERIPRONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 1 |
Lipomed AG | Phase 1 |
Cardio-theranostics LLC | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 212269-001 | May 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-002 | Jul 25, 2019 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 212269-001 | May 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-002 | Apr 20, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-002 | Apr 20, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 DEFERIPRONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-001 | Sep 9, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 212269-001 | May 19, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-002 | Apr 20, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-002 | Jul 25, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | FERRIPROX | deferiprone | TABLET;ORAL | 021825-001 | Oct 14, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for DEFERIPRONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Saudi Arabia | 520411808 | أقراص ديفيريبرون مؤخرة الإطلاق وطرق لاستخدامها (Delayed Release Deferiprone Tablets and Methods of Using The Same) | ⤷ Sign Up |
Hong Kong | 1152871 | 合口味的去鐵酮液體製劑 (LIQUID FORMULATION FOR DEFERIPRONE WITH PALATABLE TASTE) | ⤷ Sign Up |
Denmark | 2268282 | ⤷ Sign Up | |
Japan | 7246384 | ⤷ Sign Up | |
Slovenia | 2268282 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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