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Last Updated: November 21, 2024

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.
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
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:RXDosage:TABLET;ORALStrength3MG
Approval Date:Sep 20, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 2, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Patent:⤷  Sign UpPatent Expiration:Mar 15, 2033Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.