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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Covington
UBS
AstraZeneca
Accenture
Healthtrust
Mallinckrodt
Harvard Business School
Argus Health

Generated: September 19, 2017

DrugPatentWatch Database Preview

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-three US patents protecting HORIZON PHARMA drugs.

There are three hundred and five patent family members on HORIZON PHARMA drugs in fifty-five countries.

Summary for Applicant: Horizon Pharma

Patents:53
Tradenames:7
Ingredients:7
NDAs:8
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-001Jul 26, 2012ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
Horizon Pharma
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-002Jul 26, 2012ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Horizon Pharma
DUEXIS
famotidine; ibuprofen
TABLET;ORAL022519-001Apr 23, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-003Jul 26, 2012ABRXYesYes► Subscribe► Subscribe ► Subscribe
Horizon Pharma Usa
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-002Jul 26, 2012ABRXYesNo► Subscribe► Subscribe ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Horizon Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma Inc
BUPHENYL
sodium phenylbutyrate
TABLET;ORAL020572-001May 13, 1996► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Inc
BUPHENYL
sodium phenylbutyrate
POWDER;ORAL020573-001Apr 30, 1996► Subscribe► Subscribe
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Paragraph IV activity for HORIZON PHARMA drugs

Drugname Dosage Strength Tradename Submissiondate
diclofenac sodium
Topical Solution2.0%
PENNSAID
6/3/2014
prednisone
Delayed-release Tablets1 mg, 2 mg, and 5 mg
RAYOS
11/26/2012
diclofenac sodium
Topical Solution1.5%
PENNSAID
7/11/2012
ibuprofen and famotidine
Tablets800 mg/26.6 mg
DUEXIS
12/6/2011
naproxen and esomeprazole magnesium
Delayed-release Tablet375 mg/20 mg and 500 mg/20 mg
VIMOVO
11/5/2010

Non-Orange Book 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
8,129,433Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
6,677,455 Potassium salt of S-omeprazole► Subscribe
8,206,741Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,466,175Form of S-omeprazole► Subscribe
8,920,838Delayed-release glucocorticoid treatment of rheumatoid disease► Subscribe
8,076,361Form of S-omeprazole► Subscribe
9,511,039Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
6,747,155 Process► Subscribe
9,364,439Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,865,190Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Horizon Pharma Drugs

Country Document Number Estimated Expiration
Canada2764963► Subscribe
Morocco32692► Subscribe
World Intellectual Property Organization (WIPO)0224206► Subscribe
Japan2002105072► Subscribe
Japan2009545546► Subscribe
Australia2010263304► Subscribe
Canada2736547► Subscribe
Denmark1919458► Subscribe
Israel159129► Subscribe
Japan2002501529► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Horizon Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011005,C0984957Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
C/GB98/040United Kingdom► SubscribePRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
C/GB08/036United Kingdom► SubscribePRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
2012 00036Denmark► Subscribe
C/GB07/011United Kingdom► SubscribePRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
2012000051Germany► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
C/GB98/025United Kingdom► SubscribePRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
/2014Austria► SubscribePRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
UBS
Baxter
AstraZeneca
Queensland Health
Moodys
Chinese Patent Office
Teva
McKinsey
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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