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-eight US patents protecting CHIESI drugs.

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

Summary for CHIESI

International Patents:	304
US Patents:	48
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	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	10,695,397
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	10,238,709
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No	7,932,268
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No
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	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992		DISCN	Yes	No

Expired US Patents for CHIESI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012	5,739,135
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988	3,985,758
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008	5,856,346
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	3,985,758
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018	7,049,328
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	6,987,094
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	5,712,279

Paragraph IV (Patent) Challenges for CHIESI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Inhalation Solution	300 mg/4 mL		2017-08-31

International Patents for CHIESI Drugs

Country	Patent Number	Estimated Expiration
Israel	220008
China	102014904
Lithuania	2343982
China	102665723
Croatia	P20200445
European Patent Office	2343982
Poland	1758555

Supplementary Protection Certificates for CHIESI Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	C300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
0748228	SPC/GB11/004	United Kingdom		PRODUCT NAME: MANNITOL; REGISTERED: SE 22708 20061020; UK PL 27944/0001-0001 20071218
1758555	SPC/GB16/040	United Kingdom		PRODUCT NAME: BETULIN; REGISTERED: UK EU/1/15/1069/001 20160118
0726894	SPC/GB12/011	United Kingdom		PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123
1758555	132016000072478	Italy		PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1725234	CR 2014 00002	Denmark		PRODUCT NAME: LOMITAPID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER PIPERIDIN N-OXIDET DERAF, HERUNDER LOMITAPIDMESYLAT; REG. NO/DATE: EU/1/13/851/001-003 20130805
1758555	PA2016023	Lithuania		PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114

Similar Applicant Names

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

• Chiesi