Deferiprone - Generic Drug Details

What are the generic 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deferiprone has forty 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:	40
US Patents:	5
Tradenames:	2
Applicants:	3
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	60
Patent Applications:	3,322
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
University Hospital, Bordeaux	Phase 2
David Hasan	Phase 2
First Affiliated Hospital of Fujian Medical University	Early Phase 1

See all deferiprone clinical trials

Pharmacology for deferiprone

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity

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	213239-001	Mar 29, 2021	AB	RX	No	No
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018		DISCN	Yes	No
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	AB	RX	Yes	No

Expired US Patents for deferiprone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015

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

International Patents for deferiprone

Country	Patent Number	Title	Estimated Expiration
South Africa	201008374	LIQUID FORMULATION FOR DEFERIPRONE WITH PALATABLE TASTE
Eurasian Patent Organization	201071235	ЖИДКАЯ КОМПОЗИЦИЯ ДЛЯ ДЕФЕРИПРОНА С ПРИЯТНЫМ ВКУСОМ
World Intellectual Property Organization (WIPO)	2019082128
China	114533689	延迟释放去铁酮片剂及其使用方法 (Delayed release deferiprone tablets and methods of use thereof)
World Intellectual Property Organization (WIPO)	2009129592
South Korea	101490721