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Last Updated: January 24, 2020

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VIMOVO Drug Profile

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When do Vimovo patents expire, 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. One supplier is listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

US ANDA Litigation and Generic Entry Outlook for Vimovo

Vimovo was eligible for patent challenges on December 31, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2020. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $80mm indicating the motivation for generic entry (peak sales were $1.1bn in 2015).

There have been thirty-seven 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

See drug prices for VIMOVO

Drug Sales Revenue Trends for VIMOVO

See drug sales revenues for VIMOVO

Generic Entry Opportunity Date for VIMOVO
Generic Entry Date for VIMOVO*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
Dosage:
TABLET, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Recent Litigation for VIMOVO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Horizon Medicines LLC v. Ajanta Pharma Ltd.2019-09-27
Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2017-01-23
ASTRAZENECA AB v. CIPLA LIMITED2016-12-29

See all VIMOVO litigation

PTAB Litigation
PetitionerDate
Dr. Reddy's Lab., Inc.2018-07-02
Dr. Reddy's Laboratories, Inc.2018-04-06
Mylan Pharmaceuticals Inc.2017-12-04

See all VIMOVO litigation

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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 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 022511-001 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 022511-001 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
>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 2012/048 Ireland   Start Trial 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 91858 Luxembourg   Start Trial 91858, EXPIRES: 20251105
1411900 435 Finland   Start Trial
1411900 18/2011 Austria   Start Trial PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
1411900 C300481 Netherlands   Start Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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