Viibryd is a drug owned by Abbvie Inc. It is protected by 9 US drug patents filed from 2013 to 2020 out of which all have expired. Viibryd's patents have been open to challenges since 31 July, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2023. Details of Viibryd'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. | |||
| US8673921 | Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride |
Jun, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7834020 (Pediatric) | Polymorphic forms of 1-′4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride |
Dec, 2022
(2 years ago) |
Expired
|
|
US8193195 (Pediatric) | Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride |
Dec, 2022
(2 years ago) |
Expired
|
|
US8236804 (Pediatric) | Polymorphic forms of 1-′4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride |
Dec, 2022
(2 years ago) |
Expired
|
|
US8673921 (Pediatric) | Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride |
Dec, 2022
(2 years ago) |
Expired
|
| US8236804 | Polymorphic forms of 1-′4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride |
Jun, 2022
(2 years ago) |
Expired
|
| US7834020 | Polymorphic forms of 1-′4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride |
Jun, 2022
(2 years ago) |
Expired
|
| US8193195 | Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride |
Jun, 2022
(2 years ago) |
Expired
|
| US5532241 | Piperidines and piperazines |
Sep, 2014
(10 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 Viibryd's patents.
Latest Legal Activities on Viibryd's Patents
Given below is the list of recent legal activities going on the following patents of Viibryd.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 Jul, 2024 | US8193195 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 25 Mar, 2024 | US8236804 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 22 Jan, 2024 | US8193195 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 04 May, 2022 | US7834020 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Sep, 2021 | US8673921 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jan, 2020 | US8236804 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Nov, 2019 | US8193195 (Litigated) |
| Request for Trial Denied Critical | 23 Jul, 2018 | US8673921 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 May, 2018 | US7834020 (Litigated) |
| Petition Requesting Trial | 05 Jan, 2018 | US8673921 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Viibryd and ongoing litigations to help you estimate the early arrival of Viibryd generic.
Viibryd's Litigations
Viibryd been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 05, 2018, against patent number US8673921. The petitioner Argentum Pharmaceuticals LLC, challenged the validity of this patent, with Merck Patentgesellschaft Mit Beschrankter Haftung as the respondent. Click below to track the latest information on how companies are challenging Viibryd's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8673921 | January, 2018 |
Terminated-Denied
(23 Jul, 2018) | Merck Patentgesellschaft Mit Beschrankter Haftung | Argentum Pharmaceuticals LLC |
FDA has granted some exclusivities to Viibryd. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Viibryd, 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 Viibryd.
Exclusivity Information
Viibryd holds 4 exclusivities. All of its exclusivities have expired in 2023. Details of Viibryd's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2016 |
| New Dosing Schedule(D-146) | Mar 16, 2018 |
| M(M-254) | Jan 31, 2023 |
| Pediatric Exclusivity(PED) | Jul 31, 2023 |
US patents provide insights into the exclusivity only within the United States, but Viibryd 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 Viibryd's family patents as well as insights into ongoing legal events on those patents.
Viibryd's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Viibryd's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 31, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Viibryd Generic API suppliers:
Vilazodone Hydrochloride is the generic name for the brand Viibryd. 5 different companies have already filed for the generic of Viibryd, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Viibryd's generic
How can I launch a generic of Viibryd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Viibryd's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Viibryd's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Viibryd -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 20 mg, and 40 mg | 21 Jan, 2015 | 5 | 13 Sep, 2019 | 05 Jun, 2022 | Eligible |
Alternative Brands for Viibryd
Viibryd which is used for treating major depressive disorder (MDD)., 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 |
| |||
| Astrazeneca |
| |||
| Osmotica Pharm Us |
| |||
| Otsuka |
| |||
About Viibryd
Viibryd is a drug owned by Abbvie Inc. It is used for treating major depressive disorder (MDD). Viibryd uses Vilazodone Hydrochloride as an active ingredient. Viibryd was launched by Abbvie in 2011.
Approval Date:
Viibryd was approved by FDA for market use on 21 January, 2011.
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 Viibryd is 21 January, 2011, its NCE-1 date is estimated to be 31 July, 2022.
Active Ingredient:
Viibryd uses Vilazodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Vilazodone Hydrochloride ingredient
Treatment:
Viibryd is used for treating major depressive disorder (MDD).
Dosage:
Viibryd is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |