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Last Updated: April 29, 2024

Horizon Company Profile


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Summary for Horizon

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 GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes 9,925,156*PED ⤷  Try a Trial Y ⤷  Try a Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No 8,449,910 ⤷  Try a Trial Y ⤷  Try a Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 AB RX Yes Yes 8,741,956 ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us BUPHENYL sodium phenylbutyrate TABLET;ORAL 020572-001 May 13, 1996 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 AB RX Yes Yes 9,375,412 ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes 10,183,005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Horizon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-001 Jul 26, 2012 9,040,085 ⤷  Try a Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 9,161,920 ⤷  Try a Trial
Horizon RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-001 Jul 26, 2012 8,309,124 ⤷  Try a Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 8,557,285 ⤷  Try a Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 8,858,996 ⤷  Try a Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 8,858,996 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for HORIZON drugs
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

Supplementary Protection Certificates for Horizon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 16C1020 France ⤷  Try a Trial PRODUCT NAME: PHENYLBUTYRATE DE GLYCEROL; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2465580 SPC/GB21/030 United Kingdom ⤷  Try a Trial 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
1758590 LUC00029 Luxembourg ⤷  Try a Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2822954 18C1035 France ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2666774 CA 2020 00037 Denmark ⤷  Try a Trial PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0480717 SPC/GB98/025 United Kingdom ⤷  Try a Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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