Chiesi Company Profile

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

CHIESI has fifteen approved drugs.

There are forty-nine US patents protecting CHIESI drugs.

There are three hundred and seven patent family members on CHIESI drugs in forty-two countries and fifty-three supplementary protection certificates in eighteen countries.

Summary for Chiesi

International Patents:	307
US Patents:	49
Tradenames:	16
Ingredients:	10
NDAs:	15
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	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No	8,618,135
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	7,659,291
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	11,969,471		Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013		DISCN	Yes	No	10,010,537		Y
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes	8,828,444		Y
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No	9,433,617

Expired US Patents for Chiesi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996	4,873,259
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	7,049,328
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013	5,739,152
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	5,198,226
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012	6,492,365
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015	6,492,365

Paragraph IV (Patent) Challenges for CHIESI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Injection	2.5 mg/mL, 10 mL Ampoules		2006-12-27

International Patents for Chiesi Drugs

Country	Patent Number	Estimated Expiration
Serbia	53689
Lithuania	2504012
Japan	2016135762
Eurasian Patent Organization	201591683
Spain	2323082
Singapore	11202003668Y

Supplementary Protection Certificates for Chiesi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	14C0003	France		PRODUCT NAME: LOMITAPIDE , OU UN SEL PHARMACEUTIQUEMENT ACTIF DE CELUI-CI.; REGISTRATION NO/DATE: EU/1/13/851/001 20130805
0726894	C300520	Netherlands		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123
1725234	132014902228079	Italy		PRODUCT NAME: LOMITAPIDE E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE COME PROTETTA DAL BREVETTO BASE(LOJUXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/851/001/-003, 20130805
1725234	92349	Luxembourg		PRODUCT NAME: LOMITAPIDE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130805
1725234	300634	Netherlands		PRODUCT NAME: LOMITAPIDE OF HET PIPERIDINE N-OXIDE DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130805
1725234	PA2014001,C1725234	Lithuania		PRODUCT NAME: LOMITAPIDAS; REGISTRATION NO/DATE: EU/1/13/851/001, 2013-07-31 EU/1/13/851/002, 2013-07-31 EU/1/13/851/003 20130731

Similar Applicant Names

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

• Chiesi