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Last Updated: December 15, 2019

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Details for New Drug Application (NDA): 022511

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NDA 022511 describes VIMOVO, which is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VIMOVO profile page.

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.
Summary for 022511
Tradename:VIMOVO
Applicant:Horizon
Ingredient:esomeprazole magnesium; naproxen
Patents:11
Generic Entry Opportunity Date for 022511
Generic Entry Date for 022511*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
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.

Suppliers and Packaging for NDA: 022511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511 NDA Horizon Medicines LLC 75987-030 75987-030-04 60 TABLET, DELAYED RELEASE in 1 BOTTLE (75987-030-04)
VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511 NDA Horizon Medicines LLC 75987-030 75987-030-73 1 BOTTLE in 1 CARTON (75987-030-73) > 6 TABLET, DELAYED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022511
Tradename Dosage Ingredient NDA Submissiondate
VIMOVO TABLET, DELAYED RELEASE;ORAL esomeprazole magnesium; naproxen 022511 2010-11-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE;500MG
Approval Date:Apr 30, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 6, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
Patent:  Start TrialPatent Expiration:May 31, 2022Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022511

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 022511-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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