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VICTOZA Drug Profile
» See Plans and Pricing
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 eight patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and seventeen patent family members in thirty 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.
US ANDA Litigation and Generic Entry Outlook for Victoza
Victoza was eligible for patent challenges on January 25, 2014.
Annual sales in 2018 were $5.0bn, indicating a strong incentive for generic entry.
There have been six 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: | 217 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 107 |
| 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 |
| DailyMed Link: | VICTOZA at DailyMed |
Recent Clinical Trials for VICTOZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Phase 3 |
| Universitaire Ziekenhuizen Leuven | Phase 4 |
| Turku University Hospital | N/A |
Pharmacology for VICTOZA
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Paragraph IV (Patent) Challenges for VICTOZA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VICTOZA | SOLUTION;SUBCUTANEOUS | liraglutide recombinant | 022341 | 2016-12-12 |
US Patents and Regulatory Information for VICTOZA
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | Start Trial | Start Trial |
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VICTOZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2109474 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9808872 | Start Trial |
| Germany | 60328927 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VICTOZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2209800 | SPC/GB14/079 | United Kingdom | Start Trial | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922 |
| 2209800 | 122014000114 | Germany | Start Trial | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
| 2209800 | C300698 | Netherlands | Start Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
