Chiesi Company Profile

What is the competitive landscape for CHIESI, and what generic alternatives to CHIESI drugs are available?

CHIESI has twelve approved drugs.

There are twenty-five US patents protecting CHIESI drugs.

There are two hundred and twenty-one patent family members on CHIESI drugs in fifty countries and sixteen supplementary protection certificates in nine countries.

Summary for Chiesi

International Patents:	221
US Patents:	25
Tradenames:	13
Ingredients:	7
NDAs:	12
Patent Litigation for Chiesi:	See patent lawsuits for Chiesi

Drugs and US Patents for Chiesi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008		RX	Yes	Yes	8,658,676		Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	7,612,102		Y
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008		RX	Yes	Yes	7,612,102		Y
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes	8,703,156		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,295,687		Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	10,758,616		Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008		RX	Yes	Yes	11,103,490		Y

Expired US Patents for Chiesi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008	5,739,152
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	3,985,758
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	6,114,313
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013	5,856,346
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007	5,422,123
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	3,985,758
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008	5,856,346

Paragraph IV (Patent) Challenges for CHIESI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	2.5 mg/mL, 10 mL Ampoules		2006-12-27
	Inhalation Solution	300 mg/4 mL		2017-08-31
	Injection	0.1 mg/mL, 200 mL and0.2mg/mL, 200 mL		2013-06-20
	Tablets	500 mg		2016-01-29

International Patents for Chiesi Drugs

Country	Patent Number	Estimated Expiration
Canada	3077514
Hong Kong	1068784
Japan	2009534409
Mexico	2020004107
China	1864696
Eurasian Patent Organization	006068
Japan	2001509512

Supplementary Protection Certificates for Chiesi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0726894	SPC/GB12/011	United Kingdom		PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123
0726894	C300520	Netherlands		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123
0748228	11C0002	France		PRODUCT NAME: MANNITOL; NAT. REGISTRATION NO/DATE: NL 34557 20080819; FIRST REGISTRATION: SE - 22708 20061020
0726894	92209	Luxembourg		PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
0726894	12C0053	France		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123
1280520	C01280520/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Chiesi