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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 seven 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.

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 59676-225-07 7 CAPSULE in 1 BOTTLE (59676-225-07)
OLYSIO
simeprevir sodium
CAPSULE;ORAL 205123 NDA Janssen Products LP 59676-225 59676-225-28 28 CAPSULE in 1 BOTTLE (59676-225-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Nov 22, 2013TE:RLD:Yes
Patent:7,671,032Patent Expiration:May 19, 2025Product Flag?YSubstance Flag?YDelist Request?
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


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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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