FERRIPROX Drug Patent Profile

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Which patents cover Ferriprox, and what generic alternatives are available?

Ferriprox is a drug marketed by Chiesi and is included in three NDAs. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in twenty-eight countries.

The generic ingredient in FERRIPROX 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 Ferriprox

A generic version of FERRIPROX was approved as deferiprone by TARO on February 8^th, 2019.

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Summary for FERRIPROX

International Patents:	46
US Patents:	7
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	26
Patent Applications:	1,654
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

Drug patent expirations by year for FERRIPROX

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

See all FERRIPROX clinical trials

Pharmacology for FERRIPROX

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity

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 seven US patents and six FDA Regulatory Exclusivities.

Patents protecting FERRIPROX

Delayed release deferiprone tablets and methods of using the same
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD

Delayed release deferiprone tablets and methods of using the same
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Patent Expiration: ⤷ Sign Up

Delayed release deferiprone tablets and methods of using the same
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD

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Patent Expiration: ⤷ Sign Up

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Patented Use: METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD

Liquid formulation for deferiprone with palatable taste
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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: ⤷ Sign Up

TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES
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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
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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: ⤷ Sign Up

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: ⤷ Sign Up

TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES
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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	SOLUTION;ORAL	208030-002	Apr 20, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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	208030-001	Sep 9, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018	⤷ Sign Up	⤷ Sign Up
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	⤷ Sign Up	⤷ Sign Up
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	⤷ Sign Up	⤷ Sign Up
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for FERRIPROX

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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 FERRIPROX

See the table below for patents covering FERRIPROX around the world.

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Country	Patent Number	Title	Estimated Expiration
Serbia	53689	TEČNA FORMULACIJA DEFERIPRONA SA PRIJATNIM UKUSOM (LIQUID FORMULATION FOR DEFERIPRONE WITH PALATABLE TASTE)	⤷ Sign Up
Australia	2008355464	Liquid formulation for deferiprone with palatable taste	⤷ Sign Up
Ukraine	126977	ТАБЛЕТКА ДЕФЕРИПРОНУ З ВІДТЕРМІНОВАНИМ ВИВІЛЬНЕННЯМ ТА СПОСІБ ЇЇ ВИГОТОВЛЕННЯ (DELAYED RELEASE DEFERIPRONE TABLETS AND METHODS OF USING THE SAME)	⤷ Sign Up
Denmark	2268282		⤷ Sign Up
Slovenia	2268282		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration