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Generated: May 26, 2019

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Esomeprazole magnesium; naproxen - Generic Drug Details

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What are the generic 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 eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium; naproxen has fifty patent family members in twenty-three countries.

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

Summary for esomeprazole magnesium; naproxen

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 022511-002 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 Y ➤ 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 ➤ 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
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 022511-001 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 022511-002 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 022511-002 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 1190013-1 Sweden ➤ Sign Up PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
0984957 2012/048 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
1411900 CA 2012 00036 Denmark ➤ Sign Up
1411900 122012000052 Germany ➤ Sign Up PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900 435 Finland ➤ Sign Up
0124495 SPC/GB01/006 United Kingdom ➤ Sign Up PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1411900 2011/016 Ireland ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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