Viberzi is a drug owned by Abbvie Inc. It is protected by 20 US drug patents filed from 2015 to 2022 out of which none have expired yet. Viberzi's patents have been open to challenges since 28 May, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2033. Details of Viberzi'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. | |||
| US7741356 | Compounds as opioid receptor modulators |
May, 2029
(4 years from now) | Active |
| US9115091 | Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl—1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid |
Jul, 2028
(3 years from now) | Active |
| US8691860 | Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid |
Jul, 2028
(3 years from now) | Active |
| US7786158 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
| US8609709 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
| US10213415 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10188632 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US9675587 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US11229627 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US11311516 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US11007179 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US11090291 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US11160792 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US11484527 | Opioid receptor modulator dosage formulations |
Mar, 2033
(8 years from now) | Active |
| US9364489 | Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid |
Jul, 2028
(3 years from now) | Active |
| US9789125 | Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid |
Jul, 2028
(3 years from now) | Active |
| US9700542 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
| US9205076 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
| US8344011 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
| US8772325 | Compounds as opioid receptor modulators |
Mar, 2025
(3 months from now) | Active |
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 Viberzi's patents.
Latest Legal Activities on Viberzi's Patents
Given below is the list of recent legal activities going on the following patents of Viberzi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2024 | US8344011 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 May, 2023 | US9205076 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jan, 2023 | US9115091 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Nov, 2022 | US11484527 |
| Recordation of Patent Grant Mailed Critical | 01 Nov, 2022 | US11484527 |
| Email Notification Critical | 13 Oct, 2022 | US11484527 |
| Issue Notification Mailed Critical | 12 Oct, 2022 | US11484527 |
| Dispatch to FDC | 28 Sep, 2022 | US11484527 |
| Application Is Considered Ready for Issue Critical | 28 Sep, 2022 | US11484527 |
| Issue Fee Payment Verified Critical | 27 Sep, 2022 | US11484527 |
FDA has granted several exclusivities to Viberzi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Viberzi, 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 Viberzi.
Exclusivity Information
Viberzi holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Viberzi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 27, 2020 |
Several oppositions have been filed on Viberzi'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 Viberzi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Viberzi patents.
Viberzi's Oppositions Filed in EPO
Viberzi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 28, 2019, by Sandoz Ag. This opposition was filed on patent number EP14774006A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14774006A | May, 2019 | Sandoz AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Viberzi 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 Viberzi's family patents as well as insights into ongoing legal events on those patents.
Viberzi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Viberzi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 14, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Viberzi Generics:
There are no approved generic versions for Viberzi as of now.
How can I launch a generic of Viberzi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Viberzi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Viberzi'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 Viberzi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg and 100 mg | 28 May, 2019 | 6 | 14 Mar, 2033 |
About Viberzi
Viberzi is a drug owned by Abbvie Inc. It is used for reducing abdominal pain and diarrhea in patients with irritable bowel syndrome with diarrhea (IBS-D) with eluxadoline. Viberzi uses Eluxadoline as an active ingredient. Viberzi was launched by Abbvie in 2015.
Approval Date:
Viberzi was approved by FDA for market use on 27 May, 2015.
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 Viberzi is 27 May, 2015, its NCE-1 date is estimated to be 28 May, 2019.
Active Ingredient:
Viberzi uses Eluxadoline as the active ingredient. Check out other Drugs and Companies using Eluxadoline ingredient
Treatment:
Viberzi is used for reducing abdominal pain and diarrhea in patients with irritable bowel syndrome with diarrhea (IBS-D) with eluxadoline.
Dosage:
Viberzi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 75MG | TABLET | Prescription | ORAL |