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Last Updated: August 8, 2020

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VIMOVO Drug Profile

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Which patents cover Vimovo, and what generic alternatives are available?

Vimovo is a drug marketed by Horizon and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in twenty-three countries.

The generic ingredient in VIMOVO is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

US ANDA Litigation and Generic Entry Outlook for Vimovo

Annual sales in 2018 were $426mm indicating the motivation for generic entry (peak sales were $1.1bn in 2015).

There have been thirty-three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (esomeprazole magnesium; naproxen), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for VIMOVO
Drug Prices for VIMOVO

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Drug Sales Revenue Trends for VIMOVO

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Recent Clinical Trials for VIMOVO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
EMSPhase 3
Hanyang University Seoul HospitalPhase 2
Horizon Pharma Ireland, Ltd., Dublin IrelandPhase 4

See all VIMOVO clinical trials

Paragraph IV (Patent) Challenges for VIMOVO
Tradename Dosage Ingredient NDA Submissiondate
VIMOVO TABLET, DELAYED RELEASE;ORAL esomeprazole magnesium; naproxen 022511 2010-11-05

US Patents and Regulatory Information for VIMOVO

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 022511-002 Apr 30, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   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 VIMOVO

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

Supplementary Protection Certificates for VIMOVO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 C300483 Netherlands   Start Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
0984957 CA 2012 00008 Denmark   Start Trial
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 91858 Luxembourg   Start Trial 91858, EXPIRES: 20251105
1020461 C300482 Netherlands   Start Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
0984957 122012000051 Germany   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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Moodys
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Johnson and Johnson

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