VIEKIRA XR Drug Patent Profile
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When do Viekira Xr patents expire, and what generic alternatives are available?
Viekira Xr is a drug marketed by Abbvie and is included in one NDA. There are twenty patents protecting this drug.
This drug has six hundred and five patent family members in fifty-four countries.
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.
DrugPatentWatch® Generic Entry Outlook for Viekira Xr
Viekira Xr was eligible for patent challenges on December 19, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 2, 2035. This may change due to patent challenges or generic licensing.
There have been nine 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.
Indicators of Generic Entry
Summary for VIEKIRA XR
| International Patents: | 605 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Patent Applications: | 22 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIEKIRA XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIEKIRA XR |
| DailyMed Link: | VIEKIRA XR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIEKIRA XR
Generic Entry Date for VIEKIRA XR*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for VIEKIRA XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 4 |
| University of Florida | Phase 4 |
| Patient-Centered Outcomes Research Institute | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for VIEKIRA XR
US Patents and Regulatory Information for VIEKIRA XR
VIEKIRA XR is protected by twenty US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIEKIRA XR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VIEKIRA XR
Solid antiviral dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
Compositions and methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
Anti-infective agents and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
Solid pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Macrocyclic hepatitis C serine protease inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
Methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
Anti-infective agents and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
Macrocyclic hepatitis C serine protease inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR
Methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
Methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
Solid compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Anti-viral compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Anti-viral compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING OMBITASVIR
Compositions and methods for treating HCV
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR
Anti-infective agents and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR
Solid antiviral dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
Solid antiviral dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 XR
| 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 |
International Patents for VIEKIRA XR
When does loss-of-exclusivity occur for VIEKIRA XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
European Patent Office
Patent: 89757
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1609195
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering VIEKIRA XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2678334 | COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS) | ⤷ Try a Trial |
| China | 104436197 | Combined product of at least two direct acting antiviral agents | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2015103490 | ⤷ Try a Trial | |
| Philippines | 12014502848 | METHODS FOR TREATING HCV COMPRISING AT LEAST TWO DIRECT ACTING ANTIVIRAL AGENT, RIBAVIRIN BUT NOT INTERFERON | ⤷ Try a Trial |
| Hong Kong | 1186415 | 作為丙型肝炎病毒 的複製抑制劑的三取代雜環 (TRISUBSTITUTED HETEROCYCLES AS REPLICATION INHIBITORS OF HEPATITIS C VIRUS HCV HCV) | ⤷ Try a Trial |
| South Africa | 201302269 | ANTI-VIRAL COMPOUNDS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIEKIRA XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203431 | CA 2015 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 |
| 2368890 | PA2015012 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: OMBITASVIRUM; REGISTRATION NO/DATE: EU/1/14/982 20150115 |
| 2368890 | 33/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: OMBITASVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/982 (MITTEILUNG) 20150119 |
| 2203431 | 1590018-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 2692346 | 2017/046 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/17/1213 20170726 |
| 2203431 | 247 50008-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR (VO FORME MONOHYDRATU SODNEJ SOLI); REGISTRATION NO/DATE: EU/1/14/983/001 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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