Victoza is a drug owned by Novo Nordisk Inc. It is protected by 20 US drug patents filed from 2013 to 2019. Out of these, 6 drug patents are active and 14 have expired. Victoza's patents have been open to challenges since 17 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 09, 2037. Details of Victoza'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. | |||
| US8114833 | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
Aug, 2025
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9968659 (Pediatric) | Liraglutide in cardiovascular conditions |
Jul, 2037
(12 years from now) | Active |
| US9968659 | Liraglutide in cardiovascular conditions |
Jan, 2037
(11 years from now) | Active |
|
US9265893 (Pediatric) | Injection button |
Mar, 2033
(7 years from now) | Active |
| US9265893 | Injection button |
Sep, 2032
(7 years from now) | Active |
|
US8114833 (Pediatric) | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
Feb, 2026
(7 months from now) | Active |
|
US7762994 (Pediatric) | Needle mounting system and a method for mounting a needle assembly |
Nov, 2024
(7 months ago) |
Expired
|
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(1 year, 1 month ago) |
Expired
|
|
US8579869 (Pediatric) | Needle mounting system and a method for mounting a needle assembly |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(2 years ago) |
Expired
|
|
US6268343 (Pediatric) | Derivatives of GLP-1 analogs |
Feb, 2023
(2 years ago) |
Expired
|
|
US8846618 (Pediatric) | Stable formulation of modified GLP-1 |
Dec, 2022
(2 years ago) |
Expired
|
| US8846618 | Stable formulation of modified GLP-1 |
Jun, 2022
(3 years ago) |
Expired
|
|
USRE41956 (Pediatric) | Dose setting limiter |
Jul, 2021
(3 years ago) |
Expired
|
| USRE41956 | Dose setting limiter |
Jan, 2021
(4 years ago) |
Expired
|
| USRE43834 | Injection syringe |
Jan, 2019
(6 years ago) |
Expired
|
| US6004297 | Injection syringe |
Jan, 2019
(6 years ago) |
Expired
|
| US6268343 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 years ago) |
Expired
|
| US7235627 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 years ago) |
Expired
|
| US6458924 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 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 Victoza's patents.
Latest Legal Activities on Victoza's Patents
Given below is the list of recent legal activities going on the following patents of Victoza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Feb, 2022 | US8846618 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Oct, 2021 | US9968659 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2018 | US7235627 |
| Patent Issue Date Used in PTA Calculation Critical | 15 May, 2018 | US9968659 |
| Recordation of Patent Grant Mailed Critical | 15 May, 2018 | US9968659 |
| Email Notification Critical | 26 Apr, 2018 | US9968659 |
| Issue Notification Mailed Critical | 25 Apr, 2018 | US9968659 |
| Filing Receipt - Updated | 13 Apr, 2018 | US9968659 |
| Dispatch to FDC | 13 Apr, 2018 | US9968659 |
| Email Notification Critical | 13 Apr, 2018 | US9968659 |
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 Victoza and ongoing litigations to help you estimate the early arrival of Victoza generic.
Victoza's Litigations
Victoza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 23, 2014, against patent number US9265893. The petitioner , challenged the validity of this patent, with Torben Stroem Hansen et al as the respondent. Click below to track the latest information on how companies are challenging Victoza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8114833 | March, 2022 |
Terminated-Settled
(08 Sep, 2022) | Novo Nordisk A/S | Fresenius Kabi USA, LLC |
| US8114833 | December, 2019 |
Terminated-Settled
(21 Jun, 2021) | Novo Nordisk A/S et al. | Pfizer Inc. et al. |
| US8114833 | July, 2020 |
Terminated-Settled
(21 Jun, 2021) | Novo Nordisk A/S | Pfizer Inc. |
| US9265893 | January, 2014 |
Decision
(08 Sep, 2015) | Torben Stroem Hansen et al | |
FDA has granted some exclusivities to Victoza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Victoza, 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 Victoza.
Exclusivity Information
Victoza holds 6 exclusivities. All of its exclusivities have expired in 2022. Details of Victoza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 25, 2015 |
| M(M-115) | Apr 06, 2015 |
| M(M-176) | Apr 22, 2019 |
| New Indication(I-750) | Aug 25, 2020 |
| New Patient Population(NPP) | Jun 17, 2022 |
| Pediatric Exclusivity(PED) | Dec 17, 2022 |
Several oppositions have been filed on Victoza'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 Victoza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Victoza patents.
Victoza's Oppositions Filed in EPO
Victoza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 26, 2008, by Amylin Pharmaceuticals, Inc.. This opposition was filed on patent number EP02745182A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17710160A | May, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP17710160A | May, 2022 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP17710160A | May, 2022 | SANDOZ AG | Granted and Under Opposition |
| EP17710160A | May, 2022 | Adalvo Ltd. | Granted and Under Opposition |
| EP17710160A | Apr, 2022 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Hoffmann Eitle | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Dr. Reddy's Laboratories Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP04797453A | Aug, 2018 | Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB | Opposition rejected |
| EP04797453A | Aug, 2018 | Wittkopp, Alexander | Opposition rejected |
| EP04797453A | Aug, 2018 | Teva Pharmaceutical Industries Ltd | Opposition rejected |
| EP04797453A | Aug, 2018 | Generics (U.K.) Limited | Opposition rejected |
| EP04797453A | Aug, 2018 | Fresenius Kabi Deutschland GmbH | Opposition rejected |
| EP04797453A | Aug, 2018 | Sandoz AG | Opposition rejected |
| EP08708028A | Jul, 2011 | Bock Wolfgang | Patent maintained as amended |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | Opposition rejected |
| EP02745182A | Sep, 2008 | AMYLIN PHARMACEUTICALS, INC. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Victoza 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 Victoza's family patents as well as insights into ongoing legal events on those patents.
Victoza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Victoza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 09, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Victoza Generic API suppliers:
Liraglutide is the generic name for the brand Victoza. 2 different companies have already filed for the generic of Victoza, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Victoza's generic
How can I launch a generic of Victoza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Victoza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Victoza'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 Victoza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 18 mg/3 mL prefilled syringe | 12 Dec, 2016 | 1 | 09 Jan, 2037 |
Alternative Brands for Victoza
Victoza which is used for improving glycemic control and reducing the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease., has several other brand drugs using the same active ingredient (Liraglutide). 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 | ||
|---|---|---|---|
| Novo |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Liraglutide, Victoza's active ingredient. Check the complete list of approved generic manufacturers for Victoza
About Victoza
Victoza is a drug owned by Novo Nordisk Inc. It is used for improving glycemic control and reducing the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. Victoza uses Liraglutide as an active ingredient. Victoza was launched by Novo Nordisk Inc in 2010.
Approval Date:
Victoza was approved by FDA for market use on 25 January, 2010.
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 Victoza is 25 January, 2010, its NCE-1 date is estimated to be 17 December, 2021.
Active Ingredient:
Victoza uses Liraglutide as the active ingredient. Check out other Drugs and Companies using Liraglutide ingredient
Treatment:
Victoza is used for improving glycemic control and reducing the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
Dosage:
Victoza is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 18MG/3ML (6MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |