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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Dow
Federal Trade Commission
Argus Health
Boehringer Ingelheim
Cerilliant
Harvard Business School
Covington
Express Scripts

Generated: November 20, 2018

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Esomeprazole magnesium; naproxen - Generic Drug Details

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What are the generic drug sources for esomeprazole magnesium; naproxen and what is the scope of esomeprazole magnesium; naproxen patent protection?

Esomeprazole magnesium; naproxen is the generic ingredient in one branded drug marketed by Horizon and is included in one NDA. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seventy-one drug master file entries for esomeprazole magnesium; naproxen. One supplier is listed for this compound.

US Patents and Regulatory Information for esomeprazole magnesium; naproxen

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for esomeprazole magnesium; naproxen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for esomeprazole magnesium; naproxen

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0483 Netherlands ➤ Sign Up PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
2012000017 Germany ➤ Sign Up PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
90013-1 Sweden ➤ Sign Up PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
12/048 Ireland ➤ Sign Up PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
2011005,C0984957 Lithuania ➤ Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
00481 Netherlands ➤ Sign Up PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Dow
Federal Trade Commission
Argus Health
Boehringer Ingelheim
Cerilliant
Harvard Business School
Covington
Express Scripts

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