Details for New Drug Application (NDA): 209637

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NDA 209637 describes OZEMPIC, which is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-one patents protecting this drug. Additional details are available on the OZEMPIC profile page.

The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.

Summary for 209637

Tradename:	OZEMPIC
Applicant:	Novo
Ingredient:	semaglutide
Patents:	21

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209637

Generic Entry Date for 209637^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;SUBCUTANEOUS

^*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: 209637

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Suppliers and Packaging for NDA: 209637

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637	NDA	Novo Nordisk	0169-4130	0169-4130-13	1 SYRINGE, PLASTIC in 1 CARTON (0169-4130-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4130-01)
OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637	NDA	Novo Nordisk	0169-4132	0169-4132-12	1 SYRINGE, PLASTIC in 1 CARTON (0169-4132-12) / 1.5 mL in 1 SYRINGE, PLASTIC (0169-4132-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	2MG/1.5ML (1.34MG/ML)
Approval Date:	Dec 5, 2017	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 17, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jun 21, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF
Patent:	⤷ Sign Up	Patent Expiration:	Jan 20, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209637

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.