~ Buy the OZEMPIC (semaglutide) Drug Profile, 2024 PDF Report in the Report Store ~

OZEMPIC Drug Patent Profile

Which patents cover Ozempic, and when can generic versions of Ozempic launch?

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

This drug has two hundred and twenty-six patent family members in twenty-eight 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 December 5, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-one 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.

Indicators of Generic Entry

Summary for OZEMPIC

International Patents:	226
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	29
Patent Applications:	938
Formulation / Manufacturing:	see details
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

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 Colorado, Denver	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Canadian Medical and Surgical Knowledge Translation Research Group	Phase 4

See all OZEMPIC clinical trials

Pharmacology for OZEMPIC

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

Anatomical Therapeutic Chemical (ATC) Classes for OZEMPIC

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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-four US patents and one FDA Regulatory Exclusivity.

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

Patents protecting OZEMPIC

FDA Regulatory Exclusivity protecting OZEMPIC

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	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			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	209637-001	Dec 5, 2017
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019

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/005422 Wegovy 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/004174 Treatment 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/004953 Rybelsus 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

When does loss-of-exclusivity occur for OZEMPIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hungary

Israel

Japan

Mexico

Netherlands

Norway

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

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

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

Country	Patent Number	Title	Estimated Expiration
Austria	344076
Portugal	1351732
China	101084028	Injection device with torsion spring and rotatable display
Hungary	E028194

Supplementary Protection Certificates for OZEMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	661	Finland
1863839	18C1017	France		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	2018/017	Ireland		PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; 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