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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 208624


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NDA 208624 describes VIEKIRA XR, which is a drug marketed by Abbvie 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
Tradename:VIEKIRA XR
Applicant:Abbvie
Ingredient:dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
Patents:20
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 22, 2016TE:RLD:Yes
Patent:⤷  Try a 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:⤷  Try a TrialPatent Expiration:May 17, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a 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 VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 ⤷  Try a Trial ⤷  Try a Trial
Abbvie VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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