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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Daiichi Sankyo
McKinsey
Julphar
Argus Health
Deloitte
McKesson
Cantor Fitzgerald
Farmers Insurance

Generated: November 21, 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 seven patent family members on HORIZON PHARMA drugs in fifty-four countries and sixty-one supplementary protection certificates in fourteen countries.

Summary for Horizon Pharma

International Patents:307
US 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
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-002Jul 26, 2012ABRXYesNo► Subscribe► Subscribe ► Subscribe
Horizon Pharma Usa
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL203389-001Apr 30, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe ► 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 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
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 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
8,920,838Delayed-release glucocorticoid treatment of rheumatoid disease► Subscribe
6,677,455 Potassium salt of S-omeprazole► Subscribe
8,466,175Form of S-omeprazole► Subscribe
8,206,741Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,364,439Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,511,039Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
8,865,190Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,076,361Form of S-omeprazole► Subscribe
9,750,708Enterically coated cysteamine, cystamine and derivatives thereof► 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
European Patent Office2043637► Subscribe
Japan2002501529► Subscribe
European Patent Office2344139► Subscribe
United Kingdom0023220► Subscribe
Egypt24291► Subscribe
Canada2523158► Subscribe
Mexico2009004038► Subscribe
Singapore174026► Subscribe
World Intellectual Property Organization (WIPO)2007012019► Subscribe
Eurasian Patent Organization015304► 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
90013-1Sweden► SubscribePRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
90020-1Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
2012 00035Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957/02Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
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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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Express Scripts
Mallinckrodt
QuintilesIMS
Cipla
Cantor Fitzgerald
Fish and Richardson
Moodys
Boehringer Ingelheim

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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