Last Updated: September 23, 2026

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 fifteen patents protecting this drug. Additional details are available on the RYBELSUS profile page.

The generic ingredient in RYBELSUS is semaglutide. There is one drug master file entry for this compound. 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:	17

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213051

Generic Entry Date for 213051^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 10,933,120 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
OZEMPIC	semaglutide	TABLET;ORAL	213051	NDA	Novo Nordisk Pharmaceutical Industries, LP	0169-1704	0169-1704-30	30 TABLET in 1 BOTTLE, PLASTIC (0169-1704-30)
RYBELSUS	semaglutide	TABLET;ORAL	213051	NDA	Novo Nordisk Pharmaceutical Industries, LP	0169-1704	0169-1704-30	30 TABLET in 1 BOTTLE, PLASTIC (0169-1704-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Sep 20, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 17, 2028
Regulatory Exclusivity Use:	TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION OR NON-FATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE AT HIGH RISK FOR THESE EVENTS
Patent:	10,086,047	Patent Expiration:	Dec 16, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,278,923	Patent Expiration:	May 2, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 213051

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019	8,536,122	⤷ Start Trial
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-006	Dec 9, 2024	8,536,122	⤷ Start Trial
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-004	Dec 9, 2024	8,536,122	⤷ Start Trial
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019	8,536,122	⤷ Start Trial
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-005	Dec 9, 2024	8,536,122	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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