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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 Pharma Usa and is included in one NDA. It is available from three suppliers. There are fifteen 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 sixty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

Summary for NDA: 022511

Tradename:
VIMOVO
Applicant:
Horizon Pharma Usa
Ingredient:
esomeprazole magnesium; naproxen
Patents:15
Formulation / Manufacturing:see details

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 AstraZeneca LP 0186-0510 0186-0510-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0186-0510-60)
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL 022511 NDA AstraZeneca LP 0186-0520 0186-0520-06 6 TABLET, DELAYED RELEASE in 1 BOTTLE (0186-0520-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE;500MG
Approval Date:Apr 30, 2010TE:ABRLD:Yes
Patent:5,714,504*PEDPatent Expiration:Aug 3, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,900,424*PEDPatent Expiration:Nov 4, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,369,085*PEDPatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022511

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 20105,714,504*PED► subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 20105,900,424*PED► subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 20106,875,872*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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