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Serving leading biopharmaceutical companies globally:

Harvard Business School
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UBS
US Department of Justice
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078560

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NDA 078560 describes EZETIMIBE, which is a drug marketed by Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Ohm Labs Inc, Sandoz Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms Usa Inc, Watson Labs Teva, Dr Reddys Labs Sa, and Impax Labs Inc, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the EZETIMIBE profile page.

The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 078560
Tradename:EZETIMIBE
Applicant:Glenmark Pharms Ltd
Ingredient:ezetimibe
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078560
Medical Subject Heading (MeSH) Categories for 078560
Suppliers and Packaging for NDA: 078560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE ezetimibe TABLET;ORAL 078560 ANDA Par Pharmaceutical Inc 49884-228 49884-228-09 90 TABLET in 1 BOTTLE (49884-228-09)
EZETIMIBE ezetimibe TABLET;ORAL 078560 ANDA Par Pharmaceutical Inc 49884-228 49884-228-05 500 TABLET in 1 BOTTLE (49884-228-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 26, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Jun 10, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

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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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