Horizon Company Profile

What is the competitive landscape for HORIZON, and when can generic versions of HORIZON drugs launch?

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.

Summary for Horizon

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

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	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	9,925,156*PED				Y
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	10,548,859*PED				Y
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	8,217,078
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,339,551
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No	9,925,157*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	202020-002	Jul 26, 2012	9,186,332
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573-001	Apr 30, 1996	4,457,942
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	9,040,085
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	4,457,942
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	8,852,636

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
Brazil	112015031417
Israel	302141
European Patent Office	1631251
Nicaragua	201500177
South Korea	102264579

Supplementary Protection Certificates for Horizon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1919458	CR 2014 00013	Denmark		PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1919458	C 2014 012	Romania		PRODUCT NAME: CISTEAMINABITARTRAT; NATIONAL AUTHORISATION NUMBER: EU/1/13/861; DATE OF NATIONAL AUTHORISATION: 20130906; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/861; DATE OF FIRST AUTHORISATION IN EEA: 20130906
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
2330892	PA2016041	Lithuania		PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127

Similar Applicant Names

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

• Horizon
• Horizon Therap Us