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 Pharm Inds Ltd, and is included in five NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deferiprone has forty-three patent family members in twenty-seven countries.

There are four drug master file entries for deferiprone. Four suppliers are listed for this compound.

Summary for deferiprone

International Patents:	43
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	62
Patent Applications:	3,444
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

See drug prices 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

See all deferiprone clinical trials

Pharmacology for deferiprone

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for deferiprone

V03AC	Iron chelating agents
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
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	021825-002	Jul 25, 2019	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	DEFERIPRONE	deferiprone	TABLET;ORAL	213239-002	Feb 8, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes	⤷ 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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015	⤷ Try a Trial	⤷ Try a Trial
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018	⤷ Try a Trial	⤷ Try a Trial
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020	⤷ 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 deferiprone

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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

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Country	Patent Number	Title	Estimated Expiration
Portugal	2268282		⤷ Try a Trial
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
European Patent Office	3684344	COMPRIMÉS DE DÉFÉRIPRONE À LIBÉRATION RETARDÉE ET PROCÉDÉS D'UTILISATION CORRESPONDANTS (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
Canada	3077514	COMPRIMES DE DEFERIPRONE A LIBERATION RETARDEE ET PROCEDES D'UTILISATION CORRESPONDANTS (DELAYED RELEASE DEFERIPRONE TABLETS AND METHODS OF USING THE SAME)	⤷ Try a Trial
Ukraine	102254	ЖИДКИЙ СОСТАВ ДЛЯ ДЕФЕРИПРОНА С ПРИЯТНЫМ ВКУСОМ;РІДКИЙ СКЛАД ДЛЯ ДЕФЕРИПРОНУ З ПРИЄМНИМ СМАКОМ (Normal;heading 1;heading 2;heading 3;LIQUID FORMULATION FOR DEFERIPRONE WITH PALATABLE TASTE)	⤷ Try a Trial
Australia	2018357350	Delayed release deferiprone tablets and methods of using the same	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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