OZEMPIC Drug Patent Profile

Which patents cover Ozempic, and what generic alternatives are available?

Ozempic is a drug marketed by Novo and is included in two NDAs. There are twenty-five patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and fifty-one patent family members in thirty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ozempic

Ozempic was eligible for patent challenges on December 5, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 28, 2028. This may change due to patent challenges or generic licensing.

There have been thirty-two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (semaglutide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for OZEMPIC

International Patents:	351
US Patents:	25
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	41
Patent Applications:	1,820
Drug Prices:	Drug price information for OZEMPIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OZEMPIC
What excipients (inactive ingredients) are in OZEMPIC?	OZEMPIC excipients list
DailyMed Link:	OZEMPIC at DailyMed

See drug prices for OZEMPIC

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

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

NDA:

209637

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.

Recent Clinical Trials for OZEMPIC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	PHASE3
The Metis Foundation	PHASE3
First Affiliated Hospital of Wenzhou Medical University	PHASE2

See all OZEMPIC clinical trials

Pharmacology for OZEMPIC

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Paragraph IV (Patent) Challenges for OZEMPIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OZEMPIC	Injection	semaglutide	2 mg/3 mL	209637	1	2024-04-11
OZEMPIC	Injection	semaglutide	8 mg/3 mL	209637	1	2022-12-21
OZEMPIC	Injection	semaglutide	2 mg/1.5 mL and 4 mg/3 mL	209637	7	2021-12-06

US Patents and Regulatory Information for OZEMPIC

OZEMPIC is protected by twenty-nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-004	Dec 9, 2024		RX	Yes	Yes
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes			Y		Y
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-005	Dec 9, 2024		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y		Y

Expired US Patents for OZEMPIC

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

EU/EMA Drug Approvals for OZEMPIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novo Nordisk A/S	Wegovy	semaglutide	EMEA/H/C/005422Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to	Authorised	no	no	no	2022-01-06
Novo Nordisk A/S	Ozempic	semaglutide	EMEA/H/C/004174Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2018-02-08
Novo Nordisk A/S	Rybelsus	semaglutide	EMEA/H/C/004953Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin combination with other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2020-04-03

International Patents for OZEMPIC

See the table below for patents covering OZEMPIC around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2018140900	СЕМАГЛУТИД ПРИ СЕРДЕЧНО-СОСУДИСТЫХ СОСТОЯНИЯХ (SEMAGLUTIDE IN CARDIOVASCULAR CONDITIONS)
Japan	2020073533
Russian Federation	2434019	АЦИЛИРОВАННЫЕ GLP-1 СОЕДИНЕНИЯ (ACYLATED GLP-1 COMPOUNDS)
Russian Federation	2318541	СИСТЕМА ДЛЯ УСТАНОВКИ ИГЛЫ И СПОСОБ КРЕПЛЕНИЯ УЗЛА С ИГЛОЙ
European Patent Office	1804865	MECANISME A DISQUE SE DEPLACANT VERS LE BAS POUR DES SERINGUES AUTOMATIQUES (DIAL-DOWN MECHANISM FOR WIND-UP PEN)
China	104017062	Acylated GLP-1 compounds

Supplementary Protection Certificates for OZEMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	122018000075	Germany		PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	132018000000262	Italy		PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839	661	Finland
1863839	1890018-3	Sweden		PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
1863839	300936	Netherlands		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212

DrugChatter Q&A for OZEMPIC

What precautions should be taken when using ozempic with type 1 diabetes?
Does ozempic's effectiveness depend on meal timing?
Do you change meal plans due to ozempic's effects?
Is there a recommended time to inject ozempic?
What is ozempic's mechanism in managing food cravings?