Details for New Drug Application (NDA): 206321
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The generic ingredient in SAXENDA 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 206321
Tradename: | SAXENDA |
Applicant: | Novo |
Ingredient: | liraglutide |
Patents: | 19 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206321
Generic Entry Date for 206321*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 206321
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 206321
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321 | NDA | Novo Nordisk | 0169-2800 | 0169-2800-15 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTIC |
SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321 | NDA | Novo Nordisk | 0169-2800 | 0169-2800-90 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 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: | Dec 23, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 17, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 20, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 20, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 206321
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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