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	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,132,110	⤷ Sign Up				⤷ Sign Up
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	8,449,910	⤷ Sign Up	Y			⤷ Sign Up
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	10,548,859*PED	⤷ Sign Up			Y	⤷ Sign Up
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,101,591	⤷ Sign Up	Y			⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	AB	RX	Yes	No	9,186,332	⤷ 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	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	8,852,636	⤷ Sign Up
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	4,457,942	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	9,186,332	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	5,714,504*PED	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	9,040,085	⤷ Sign Up
>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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	93351	Luxembourg	⤷ Sign Up	PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
2465580	SPC/GB21/030	United Kingdom	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0290047	97C0108	Belgium	⤷ Sign Up	PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
2330892	2016C/074	Belgium	⤷ Sign Up	PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 20151201
1856135	2090014-8	Sweden	⤷ Sign Up	PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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