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Last Updated: October 26, 2021

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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. There are twenty 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. Additional details are available on the dasabuvir sodium; ombitasvir; paritaprevir; ritonavir profile page.
Summary for 208624
DrugPatentWatch® Estimated 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 22, 2016TE:RLD:Yes
Patent:⤷  Free Forever 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:⤷  Free Forever TrialPatent Expiration:May 17, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:May 17, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

Expired US Patents for NDA 208624

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 ⤷  Free Forever Trial ⤷  Free Forever Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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