Details for New Drug Application (NDA): 209637

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

The generic ingredient in OZEMPIC 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 209637

Tradename:	OZEMPIC
Applicant:	Novo
Ingredient:	semaglutide
Patents:	22

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

Constraining patent/regulatory exclusivity:

TO REDUCE THE RISK OF SUSTAINED ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) DECLINE, END-STAGE KIDNEY DISEASE, AND CARDIOVASCULAR DEATH IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE

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 Pharmaceutical Industries, LP	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 Pharmaceutical Industries, LP	0169-4181	0169-4181-13	1 SYRINGE, PLASTIC in 1 CARTON (0169-4181-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4181-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	2MG/1.5ML (1.34MG/ML)
Approval Date:	Dec 5, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 28, 2028
Regulatory Exclusivity Use:	TO REDUCE THE RISK OF SUSTAINED ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) DECLINE, END-STAGE KIDNEY DISEASE, AND CARDIOVASCULAR DEATH IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE
Patent:	10,220,155	Patent Expiration:	Jul 17, 2026	Product Flag?	Y	Substance Flag?		Delist Request?	Y
Patent:	10,335,462	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

Expired US Patents for NDA 209637

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	8,114,833
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022	11,097,063
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	10,357,616
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	11,446,443
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	8,114,833
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	RE46363
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	11,311,679

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