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Details for New Drug Application (NDA): 208624
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.
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
| Tradename: | VIEKIRA XR |
| Applicant: | Abbvie Inc |
| Ingredient: | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir |
| Patents: | 22 |
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: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG BASE;8.33MG;50MG;33.33MG | ||||
| Approval Date: | Jul 22, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | 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: | Start Trial | Patent Expiration: | May 17, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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