VICTOZA Drug Patent Profile
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When do Victoza patents expire, and what generic alternatives are available?
Victoza is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and ninety-seven patent family members in thirty-two countries.
The generic ingredient in VICTOZA is liraglutide recombinant. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide recombinant profile page.
DrugPatentWatch® Generic Entry Outlook for Victoza
Victoza was eligible for patent challenges on January 25, 2014.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 13, 2026. This may change due to patent challenges or generic licensing.
Annual sales in 2019 were $5.6bn, indicating a strong incentive for generic entry.
There have been thirteen 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 VICTOZA
International Patents: | 197 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 124 |
Patent Applications: | 4,827 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VICTOZA |
Drug Sales Revenues: | Drug sales revenues for VICTOZA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VICTOZA |
What excipients (inactive ingredients) are in VICTOZA? | VICTOZA excipients list |
DailyMed Link: | VICTOZA at DailyMed |



DrugPatentWatch® Estimated Generic Entry Opportunity Date for VICTOZA
Generic Entry Date for VICTOZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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 VICTOZA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yale University | Phase 3 |
Biolingus | Phase 1/Phase 2 |
Chinese University of Hong Kong | Phase 1/Phase 2 |
Pharmacology for VICTOZA
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for VICTOZA
Paragraph IV (Patent) Challenges for VICTOZA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VICTOZA | Injection | liraglutide recombinant | 18 mg/3 mL prefilled syringe | 022341 | 1 | 2016-12-12 |
US Patents and Regulatory Information for VICTOZA
VICTOZA is protected by seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VICTOZA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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 VICTOZA
Derivatives of GLP-1 analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Stable formulation of modified GLP-1
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Injection button
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Liraglutide in cardiovascular conditions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting VICTOZA
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 VICTOZA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | See Plans and Pricing | See Plans and Pricing |
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | See Plans and Pricing | See Plans and Pricing |
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | See Plans and Pricing | See Plans and Pricing |
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | See Plans and Pricing | See Plans and Pricing |
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VICTOZA
When does loss-of-exclusivity occur for VICTOZA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 04290862
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0416743
Estimated Expiration: See Plans and Pricing
Canada
Patent: 45034
Estimated Expiration: See Plans and Pricing
China
Patent: 82356
Estimated Expiration: See Plans and Pricing
Patent: 2784386
Estimated Expiration: See Plans and Pricing
Patent: 4826116
Estimated Expiration: See Plans and Pricing
Patent: 3304250
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 19723
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 87019
Estimated Expiration: See Plans and Pricing
Patent: 00721
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 87019
Estimated Expiration: See Plans and Pricing
Patent: 94656
Estimated Expiration: See Plans and Pricing
Patent: 00721
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 46683
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 38395
Estimated Expiration: See Plans and Pricing
Patent: 43210
Estimated Expiration: See Plans and Pricing
Japan
Patent: 58655
Estimated Expiration: See Plans and Pricing
Patent: 70373
Estimated Expiration: See Plans and Pricing
Patent: 07513084
Estimated Expiration: See Plans and Pricing
Patent: 12188424
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 06005581
Estimated Expiration: See Plans and Pricing
Poland
Patent: 87019
Estimated Expiration: See Plans and Pricing
Patent: 00721
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 87019
Estimated Expiration: See Plans and Pricing
Patent: 00721
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 21238
Estimated Expiration: See Plans and Pricing
Patent: 06116414
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 87019
Estimated Expiration: See Plans and Pricing
Patent: 00721
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1243648
Estimated Expiration: See Plans and Pricing
Patent: 060100428
Estimated Expiration: See Plans and Pricing
Spain
Patent: 60320
Estimated Expiration: See Plans and Pricing
Patent: 27854
Estimated Expiration: See Plans and Pricing
Turkey
Patent: 1906789
Estimated Expiration: See Plans and Pricing
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 VICTOZA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69942307 | See Plans and Pricing | |
Chile | 2018002515 | Liraglutida en afecciones cardiovasculares. | See Plans and Pricing |
South Africa | 9901571 | See Plans and Pricing | |
Russian Federation | 2254878 | УСТРОЙСТВО ДЛЯ ИНЪЕКЦИЙ С ОГРАНИЧИТЕЛЕМ ДЛЯ УСТАНОВКИ ДОЗ (APPARATUS FOR INJECTIONS WITH DOSE SETTING RESTRICTOR) | See Plans and Pricing |
Germany | 69942305 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VICTOZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0944648 | C00944648/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009 |
0944648 | SPC034/2009 | Ireland | See Plans and Pricing | SPC034/2009: 20101001, EXPIRES: 20220821 |
2597103 | 2017/015 | Ireland | See Plans and Pricing | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912 |
0944648 | SPC/GB09/058 | United Kingdom | See Plans and Pricing | PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630 |
2209800 | 1490067-4 | Sweden | See Plans and Pricing | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |