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VIEKIRA PAK (COPACKAGED) Drug Profile
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When do Viekira Pak (copackaged) patents expire, and what generic alternatives are available?
Viekira Pak (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. There are nineteen patents protecting this drug.
This drug has six hundred and three patent family members in fifty-three countries.
The generic ingredient in VIEKIRA PAK (COPACKAGED) 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.
US ANDA Litigation and Generic Entry Outlook for Viekira Pak (copackaged)
Viekira Pak (copackaged) was eligible for patent challenges on December 19th, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 18th, 2033. This may change due to patent challenges or generic licensing.
There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for VIEKIRA PAK (COPACKAGED)
| International Patents: | 603 |
| US Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIEKIRA PAK (COPACKAGED) |
| DailyMed Link: | VIEKIRA PAK (COPACKAGED) at DailyMed |
-patent-expirations.png "VIEKIRA PAK (COPACKAGED) drug patent expirations")
Generic Entry Opportunity Date for VIEKIRA PAK (COPACKAGED)
Generic Entry Date for VIEKIRA PAK (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;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.
Recent Litigation for VIEKIRA PAK (COPACKAGED)
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| AbbVie Inc. v. Cipla Limited | 2017-11-10 |
| AbbVie Inc. v. Aurobindo Pharma Limited | 2017-01-13 |
| AbbVie Inc. v. Amneal Pharmaceuticals, LLC | 2016-05-27 |
Synonyms for VIEKIRA PAK (COPACKAGED)
| Dasabuvir / ombitasvir / paritaprevir / ritonavir |
| Dasabuvir combination with ombitasvir, paritaprevir and ritonavir |
| Ombitasvir, dasabuvir, paritaprevir, and ritonavir |
| S900006810 |
| Viekira Pak |
| Viekira Xr |
US Patents and Regulatory Information for VIEKIRA PAK (COPACKAGED)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie Inc | VIEKIRA PAK (COPACKAGED) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | TABLET, TABLET;ORAL | 206619-001 | Dec 19, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Abbvie Inc | VIEKIRA PAK (COPACKAGED) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | TABLET, TABLET;ORAL | 206619-001 | Dec 19, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Abbvie Inc | VIEKIRA PAK (COPACKAGED) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | TABLET, TABLET;ORAL | 206619-001 | Dec 19, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VIEKIRA PAK (COPACKAGED)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Inc | VIEKIRA PAK (COPACKAGED) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | TABLET, TABLET;ORAL | 206619-001 | Dec 19, 2014 | Start Trial | Start Trial |
| Abbvie Inc | VIEKIRA PAK (COPACKAGED) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | TABLET, TABLET;ORAL | 206619-001 | Dec 19, 2014 | Start Trial | Start Trial |
| Abbvie Inc | VIEKIRA PAK (COPACKAGED) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | TABLET, TABLET;ORAL | 206619-001 | Dec 19, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIEKIRA PAK (COPACKAGED)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 12189195 | Start Trial |
| Denmark | 2583680 | Start Trial |
| Lithuania | 2283844 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368890 | PA2015012,C2368890 | Lithuania | Start Trial | PRODUCT NAME: OMBITASVIRAS; REGISTRATION NO/DATE: EU/1/14/982 20150115 |
| 2340029 | PA2015011,C2340029 | Lithuania | Start Trial | PRODUCT NAME: PARITAPREVIRAS; REGISTRATION NO/DATE: EU/1/14.982 20150115 |
| 2692346 | 122017000074 | Germany | Start Trial | PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
