Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208624

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NDA 208624 describes VIEKIRA XR, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the VIEKIRA XR profile page.

The generic ingredient in VIEKIRA XR 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 208624
Generic Entry Opportunity Date for 208624
Generic Entry Date for 208624*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 208624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624 NDA AbbVie Inc. 0074-0063 0074-0063-01 1 DOSE PACK in 1 CARTON (0074-0063-01) > 1 KIT in 1 DOSE PACK
VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624 NDA AbbVie Inc. 0074-0063 0074-0063-28 4 CARTON in 1 CARTON (0074-0063-28) > 7 DOSE PACK in 1 CARTON > 1 KIT in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE;8.33MG;50MG;33.33MG
Approval Date:Jul 22, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jan 2, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
Patent:  Start TrialPatent Expiration:May 17, 2032Product Flag?YSubstance Flag?Delist Request?

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