Horizon Company Profile

What is the competitive landscape for HORIZON

HORIZON has nine approved drugs.

There are fifty-two US patents protecting HORIZON drugs.

There are two hundred and thirty-six patent family members on HORIZON drugs in forty-five countries and one hundred and fourteen supplementary protection certificates in nineteen countries.

Summary for Horizon

International Patents:	236
US Patents:	52
Tradenames:	7
Ingredients:	7
NDAs:	9
Patent Litigation for Horizon:	See patent lawsuits for Horizon
PTAB Cases with Horizon as patent owner:	See PTAB cases with Horizon as patent owner

Drugs and US Patents for Horizon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,370,501
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes	9,192,590*PED				Y
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	9,233,077*PED				Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	8,449,910		Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No	9,233,077*PED				Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	8,501,228
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No	9,925,156*PED				Y

Expired US Patents for Horizon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012	8,394,407
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	9,186,332
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	8,858,996
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	9,186,332
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	5,968,979
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	7,745,466
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	9,161,920

Paragraph IV (Patent) Challenges for HORIZON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Topical Solution	2.0%		2014-06-03
	Delayed-release Tablet	375 mg/20 mg and 500 mg/20 mg		2010-11-05
	Oral Liquid	1.1 g/mL		2013-11-19
	Topical Solution	1.5%		2012-07-11
	Delayed-release Tablets	1 mg, 2 mg, and 5 mg		2012-11-26
	Tablets	800 mg/26.6 mg		2011-12-06

International Patents for Horizon Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	2535044
Mexico	2009001248
World Intellectual Property Organization (WIPO)	2013158145
China	113995743
South Africa	200903135
Israel	171494
Spain	2629859

Supplementary Protection Certificates for Horizon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2330892	PA2016041	Lithuania		PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
1919458	C01919458/01	Switzerland		PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1856135	CA 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418

Similar Applicant Names

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

• Horizon
• Horizon Therap Us