Details for New Drug Application (NDA): 213051
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NDA 213051 describes RYBELSUS, which is a drug marketed by Novo and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the RYBELSUS profile page.
The generic ingredient in RYBELSUS is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Dec 16, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING TYPE 2 DIABETES MELLITUS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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