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Horizon Pharma Company Profile

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What is the competitive landscape for HORIZON PHARMA, and what generic alternatives to HORIZON PHARMA drugs are available?

HORIZON PHARMA has eight approved drugs.

There are fifty-five US patents protecting HORIZON PHARMA drugs.

There are two hundred and fifty-two patent family members on HORIZON PHARMA drugs in fifty-two countries and sixty-three supplementary protection certificates in fourteen countries.

Summary for Horizon Pharma

International Patents:	252
US Patents:	55
Tradenames:	7
Ingredients:	7
NDAs:	8
Patent Litigation for Horizon Pharma:	See patent lawsuits for Horizon Pharma

Drugs and US Patents for Horizon Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon Pharma Usa	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	9,925,156		Y	Y
Horizon Pharma Usa	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	9,198,882*PED				Y
Horizon Pharma Usa	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes

Expired US Patents for Horizon Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Pharma Usa	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	6,875,872*PED
Horizon Pharma Inc	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573-001	Apr 30, 1996	4,457,942
Horizon Pharma Usa	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	5,900,424*PED

Paragraph IV (Patent) Challenges for HORIZON PHARMA drugs

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

Non-Orange Book US Patents for Horizon Pharma

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,865,190	Pharmaceutical compositions for the coordinated delivery of NSAIDs
9,750,708	Enterically coated cysteamine, cystamine and derivatives thereof
6,677,455	Potassium salt of S-omeprazole

International Patents for Horizon Pharma Drugs

Country	Document Number	Estimated Expiration
Denmark	1919458
Denmark	2043637
Mexico	2009001248

Supplementary Protection Certificates for Horizon Pharma Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
14/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
14/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119

Similar Applicant Names

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

• Horizon Pharma
• Horizon Pharma Inc
• Horizon Pharma Usa