Viekira Xr is a drug owned by Abbvie Inc. It is protected by 22 US drug patents filed from 2016 to 2019. Out of these, 18 drug patents are active and 4 have expired. Viekira Xr's patents have been open to challenges since 19 December, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 02, 2035. Details of Viekira Xr's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8691938 | Anti-viral compounds |
Apr, 2032
(6 years from now) | Active |
| US8420596 | Macrocyclic hepatitis C serine protease inhibitors |
Apr, 2031
(5 years from now) | Active |
| US8642538 | Macrocyclic hepatitis C serine protease inhibitors |
Sep, 2029
(3 years from now) | Active |
| US8188104 | Anti-infective agents and uses thereof |
May, 2029
(3 years from now) | Active |
| US8501238 | Anti-infective agents and uses thereof |
Sep, 2028
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9333204 | Solid antiviral dosage forms |
Jan, 2035
(9 years from now) | Active |
| US10105365 | Solid antiviral dosage forms |
Jan, 2035
(9 years from now) | Active |
| US9744170 | Solid antiviral dosage forms |
Jan, 2035
(9 years from now) | Active |
| US8492386 | Methods for treating HCV |
Sep, 2032
(6 years from now) | Active |
| US8466159 | Methods for treating HCV |
Sep, 2032
(6 years from now) | Active |
| US8685984 | Methods for treating HCV |
Sep, 2032
(6 years from now) | Active |
| US8680106 | Methods for treating HCV |
Sep, 2032
(6 years from now) | Active |
| US10201541 | Compositions and methods for treating HCV |
May, 2032
(6 years from now) | Active |
| US10201584 | Compositions and methods for treating HCV |
May, 2032
(6 years from now) | Active |
| US8686026 | Solid compositions |
Jun, 2031
(5 years from now) | Active |
| US9044480 | Compositions and methods for treating HCV |
Apr, 2031
(5 years from now) | Active |
| US9006387 | Anti-viral compounds |
Jun, 2030
(4 years from now) | Active |
| US9139536 | Anti-infective agents and uses thereof |
Nov, 2028
(3 years from now) | Active |
| US8268349 | Solid pharmaceutical dosage form |
Aug, 2024
(1 year, 2 months ago) |
Expired
|
| US8399015 | Solid pharmaceutical dosage form |
Aug, 2024
(1 year, 2 months ago) |
Expired
|
| US7364752 | Solid dispersion pharamaceutical formulations |
Nov, 2020
(4 years ago) |
Expired
|
| US7148359 | Polymorph of a pharmaceutical |
Jul, 2019
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Viekira Xr's patents.
Latest Legal Activities on Viekira Xr's Patents
Given below is the list of recent legal activities going on the following patents of Viekira Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2023 | US8188104 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Feb, 2023 | US9139536 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Nov, 2022 | US9044480 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Sep, 2022 | US9006387 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Jul, 2022 | US10201541 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Jul, 2022 | US10201584 |
| Post Issue Communication - Certificate of Correction | 10 May, 2022 | US9744170 |
| Email Notification
Critical | 04 May, 2022 | US9744170 |
| Electronic Review
Critical | 04 May, 2022 | US9744170 |
| Mail Certificate of Correction Memo | 03 May, 2022 | US9744170 |
FDA has granted several exclusivities to Viekira Xr. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Viekira Xr, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Viekira Xr.
Exclusivity Information
Viekira Xr holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Viekira Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2019 |
Several oppositions have been filed on Viekira Xr's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Viekira Xr's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Viekira Xr patents.
Viekira Xr's Oppositions Filed in EPO
Viekira Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 15, 2016, by Ter Meer Steinmeister & Partner Patentanwälte Mbb. This opposition was filed on patent number EP11727080A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15176068A | Apr, 2019 | Aechter, Bernd | Revoked |
| EP11727080A | Apr, 2016 | KELTIE LLP | Patent maintained as amended |
| EP11727080A | Apr, 2016 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Viekira Xr is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Viekira Xr's family patents as well as insights into
ongoing legal events
on those patents.
Viekira Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Viekira Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 02, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Viekira Xr Generics:
There are no approved generic versions for Viekira Xr as of now.
Alternative Brands for Viekira Xr
Viekira Xr which is used for treating HCV infection., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Abbvie |
| |||||
About Viekira Xr
Viekira Xr is a drug owned by Abbvie Inc. It is used for treating HCV infection. Viekira Xr uses Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir as an active ingredient. Viekira Xr was launched by Abbvie in 2016.
Approval Date:
Viekira Xr was approved by FDA for market use on 22 July, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Viekira Xr is 22 July, 2016, its NCE-1 date is estimated to be 19 December, 2018.
Active Ingredient:
Viekira Xr uses Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir as the active ingredient. Check out other Drugs and Companies using Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir ingredient
Treatment:
Viekira Xr is used for treating HCV infection.
Dosage:
Viekira Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |