HORIZON Company Profile

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HORIZON has nine approved drugs.

There are fifty-seven US patents protecting HORIZON drugs.

There are two hundred and thirty-one patent family members on HORIZON drugs in forty-four countries and one hundred and one supplementary protection certificates in eighteen countries.

International Patents:	231
US Patents:	57
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

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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
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes	9,233,077*PED	⤷ Subscribe			Y	⤷ Subscribe
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	9,925,158*PED	⤷ Subscribe			Y	⤷ Subscribe
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,370,501	⤷ Subscribe				⤷ Subscribe
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	10,548,859*PED	⤷ Subscribe			Y	⤷ Subscribe
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	9,173,851*PED	⤷ Subscribe			Y	⤷ Subscribe
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,539,335	⤷ Subscribe				⤷ Subscribe
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No		⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012	9,186,332	⤷ Subscribe
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	6,369,085*PED	⤷ Subscribe
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	9,186,332	⤷ Subscribe
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	8,852,636	⤷ Subscribe
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	6,488,960	⤷ Subscribe
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	8,852,636	⤷ Subscribe
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	5,714,504*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	015304	⤷ Subscribe
Japan	2017067791	⤷ Subscribe
Hungary	E029912	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2008011426	⤷ Subscribe
Australia	2007311019	⤷ Subscribe
Cyprus	1119028	⤷ Subscribe
Hungary	E049307	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011C/016	Belgium	⤷ Subscribe	PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1912999	14C0076	France	⤷ Subscribe	PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
2822954	LUC00083	Luxembourg	⤷ Subscribe	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
0290047	97C0108	Belgium	⤷ Subscribe	PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
1499331	13C0055	France	⤷ Subscribe	PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1919458	SPC/GB14/019	United Kingdom	⤷ Subscribe	PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910
1919458	300649	Netherlands	⤷ Subscribe	PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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