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Cerilliant
Argus Health
Fuji
QuintilesIMS
Boehringer Ingelheim
Deloitte
Chubb
Dow
Express Scripts
Teva

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205123

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NDA 205123 describes OLYSIO, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the OLYSIO profile page.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the simeprevir sodium profile page.
Summary for 205123
Tradename:OLYSIO
Applicant:Janssen Prods
Ingredient:simeprevir sodium
Patents:9
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205123
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLYSIO simeprevir sodium CAPSULE;ORAL 205123 NDA Janssen Products LP 59676-225 N 59676-225-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Nov 22, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 5, 2018
Regulatory Exclusivity Use:DOSING RECOMMENDATIONS FOR THE TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS CO-INFECTED WITH HIV-1
Regulatory Exclusivity Expiration:Oct 5, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE THE TREATMENT OF CHRONIC HEPATITIS C GENOTYPE 4
Regulatory Exclusivity Expiration:Nov 22, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Julphar
Dow
Baxter
UBS
AstraZeneca
Argus Health
McKinsey
Express Scripts

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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