Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Mallinckrodt
Colorcon
Boehringer Ingelheim
AstraZeneca

Last Updated: November 20, 2019

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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 VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes   Start Trial   Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes 8,309,127   Start Trial Y   Start Trial
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-001 Jul 26, 2012 AB RX Yes No 9,040,085   Start Trial   Start Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No 9,393,208   Start Trial   Start 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 Therap BUPHENYL sodium phenylbutyrate TABLET;ORAL 020572-001 May 13, 1996 4,457,942   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 5,900,424*PED   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 5,714,504*PED   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 6,875,872*PED   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 7,411,070*PED   Start 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 Tablets 800 mg/26.6 mg ➤ Subscribe 2011-12-06
➤ Subscribe Oral Liquid 1.1 g/mL ➤ Subscribe 2013-11-19
➤ Subscribe Delayed-release Tablet 375 mg/20 mg and 500 mg/20 mg ➤ Subscribe 2010-11-05
➤ Subscribe Delayed-release Tablets 1 mg, 2 mg, and 5 mg ➤ Subscribe 2012-11-26

Supplementary Protection Certificates for Horizon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 C01411900/01 Switzerland   Start Trial PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
2203431 CA 2015 00014 Denmark   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
1758590 LUC00029 Luxembourg   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
1919458 CR 2014 00013 Denmark   Start Trial PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
2330892 2016/064 Ireland   Start Trial PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Baxter
Harvard Business School
Dow
Medtronic

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