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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206619

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NDA 206619 describes VIEKIRA PAK (COPACKAGED), which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the VIEKIRA PAK (COPACKAGED) profile page.

The generic ingredient in VIEKIRA PAK (COPACKAGED) is dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir. One supplier is listed for this compound. Additional details are available on the dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir profile page.

Summary for 206619

Tradename:1
Applicant:1
Ingredient:1
Patents:18
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206619

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619 NDA AbbVie Inc. 0074-3093 0074-3093-01 1 DOSE PACK in 1 CARTON (0074-3093-01) > 1 KIT in 1 DOSE PACK
VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619 NDA AbbVie Inc. 0074-3093 0074-3093-28 4 CARTON in 1 CARTON (0074-3093-28) > 7 DOSE PACK in 1 CARTON > 1 KIT in 1 DOSE PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, TABLET;ORALStrengthEQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG
Approval Date:Dec 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 22, 2019
Regulatory Exclusivity Use:DOSING TO INCLUDE PATIENTS WITH CHRONIC HCV GENOTYPE 1A INFECTION WITH COMPENSATED (CHILD-PUGH A) CIRRHOSIS AND GENOTYPE 1B WITH OR WITHOUT COMPENSATED (CHILD-PUGH A) CIRRHOSIS
Regulatory Exclusivity Expiration:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 206619

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie IncVIEKIRA PAK (COPACKAGED)dasabuvir sodium ; ombitasvir; paritaprevir; ritonavirTABLET, TABLET;ORAL206619-001Dec 19, 2014► Subscribe► Subscribe
Abbvie IncVIEKIRA PAK (COPACKAGED)dasabuvir sodium ; ombitasvir; paritaprevir; ritonavirTABLET, TABLET;ORAL206619-001Dec 19, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
Citi
Cipla
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Queensland Health
Moodys
Merck
QuintilesIMS
Accenture

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