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Last Updated: January 19, 2020

DrugPatentWatch Database Preview

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 five 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.
Summary for 213051
Formulation / Manufacturing:see details
Pharmacology for NDA: 213051
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 0169-4303-13 3 BLISTER PACK in 1 CARTON (0169-4303-13) > 10 TABLET in 1 BLISTER PACK (0169-4303-01)
RYBELSUS semaglutide TABLET;ORAL 213051 NDA Novo Nordisk 0169-4303 0169-4303-93 3 BLISTER PACK in 1 CARTON (0169-4303-93) > 10 TABLET in 1 BLISTER PACK (0169-4303-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Sep 20, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 5, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 20, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Dec 16, 2031Product Flag?YSubstance Flag?Delist Request?

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