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VICTOZA Drug Profile
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» See Plans and PricingWhen 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 ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and forty-five patent family members in thirty-one 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 2017 were $4.0bn, indicating a strong incentive for generic entry.
There have been three 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: | 245 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 105 |
| 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 |
|---|---|
| Universitaire Ziekenhuizen Leuven | Phase 4 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| First Affiliated Hospital of Jinan University | Phase 3 |
Recent Litigation for VICTOZA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-03-03 |
| SMITH v. NOVO NORDISK INC. | 2016-08-08 |
| Novo Nordisk A/S v. Sanofi-Aventis | 2005-09-02 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Institutional LLC | 2019-12-19 |
| 2014-01-23 |
Pharmacology for VICTOZA
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Synonyms for VICTOZA
| 204656-20-2 |
| A16115 |
| AKOS037435224 |
| Arg34Lys26-(N-epsilon-(gamma-Glu(N-alpha-hexadecanoyl)))-GLP-1(7-37) |
| AS-56276 |
| BDBM50240819 |
| CHEBI:71193 |
| CHEMBL4084119 |
| EX-A2418 |
| GTPL1133 |
| HSDB 8205 |
| Liraglutida |
| Liraglutida [INN-Spanish] |
| Liraglutide |
| Liraglutide [USAN:INN:BAN:JAN] |
| Liraglutidum |
| Liraglutidum [INN-Latin] |
| N(sup 26)-(Hexadecanoyl-gamma-glutamyle)-(34-arginine)GLP-1-(7-37)-peptide |
| N26-(Hexadecanoyl-gamma-glutamyle)-(34-arginine)GLP-1-(7-37)-peptide |
| N26-(Hexadecanoyl-gamma-glutamyle)-(34-arginine)glucagon-like-peptide-1-(7-37)-peptide |
| NN 2211 |
| NN-2211 |
| NN2211 |
| NNC 90-1170 |
| Saxenda |
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 |
|---|---|---|
| China | 100569798 | Start Trial |
| Germany | 20023819 | Start Trial |
| European Patent Office | 1536854 | 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 | C02209800/01 | Switzerland | Start Trial | PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014 |
| 2209800 | 122014000114 | Germany | Start Trial | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
