Details for New Drug Application (NDA): 022341
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NDA 022341 describes VICTOZA, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VICTOZA profile page.
The generic ingredient in VICTOZA is liraglutide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
The generic ingredient in VICTOZA is liraglutide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
Summary for 022341
| Tradename: | VICTOZA |
| Applicant: | Novo Nordisk Inc |
| Ingredient: | liraglutide |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022341
*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.
Pharmacology for NDA: 022341
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 022341
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341 | NDA | Novo Nordisk | 0169-4060 | 0169-4060-12 | 2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) / 3 mL in 1 SYRINGE, PLASTIC |
| VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341 | NDA | Novo Nordisk | 0169-4060 | 0169-4060-13 | 3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) / 3 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 18MG/3ML (6MG/ML) | ||||
| Approval Date: | Jan 25, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 23, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 13, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 23, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022341
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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