Details for New Drug Application (NDA): 206321
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The generic ingredient in SAXENDA 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.
Summary for 206321
Tradename: | SAXENDA |
Applicant: | Novo |
Ingredient: | liraglutide recombinant |
Patents: | 19 |
Formulation / Manufacturing: | see details |
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 |
Medical Subject Heading (MeSH) Categories for 206321
Suppliers and Packaging for NDA: 206321
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAXENDA | liraglutide recombinant | 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 recombinant | 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: | ⤷ Try a Trial | Patent Expiration: | Jan 17, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 20, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | 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 recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Novo | SAXENDA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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