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 eighteen 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.
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: | 18 |
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: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 2, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 17, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 17, 2032 | Product 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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