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	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	9,925,156*PED	⤷ Sign Up			Y	⤷ Sign Up
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes	10,328,037*PED	⤷ Sign Up			Y	⤷ Sign Up
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,220,784	⤷ Sign Up				⤷ Sign Up
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No		⤷ Sign Up				⤷ Sign Up
>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	9,040,085	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	9,345,695	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	7,745,466	⤷ Sign Up
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573-001	Apr 30, 1996	4,457,942	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0579826	SPC/GB02/042	United Kingdom	⤷ Sign Up	PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
1175904	2007C/048	Belgium	⤷ Sign Up	PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2932970	18C1043	France	⤷ Sign Up	PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2330892	122016000107	Germany	⤷ Sign Up	PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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