Details for New Drug Application (NDA): 213051
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The generic ingredient in RYBELSUS is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
Summary for 213051
Tradename: | RYBELSUS |
Applicant: | Novo |
Ingredient: | semaglutide |
Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213051
Generic Entry Date for 213051*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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: 213051
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 213051
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RYBELSUS | semaglutide | TABLET;ORAL | 213051 | NDA | Novo Nordisk | 0169-4303 | 0169-4303-30 | 30 TABLET in 1 BOTTLE, GLASS (0169-4303-30) |
RYBELSUS | semaglutide | TABLET;ORAL | 213051 | NDA | Novo Nordisk | 0169-4303 | 0169-4303-99 | 30 TABLET in 1 BOTTLE, GLASS (0169-4303-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
Approval Date: | Sep 20, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 16, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING TYPE 2 DIABETES MELLITUS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? |
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