Last Updated: June 21, 2026

Semaglutide - Generic Drug Details

Name: Semaglutide Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for semaglutide and what is the scope of patent protection?

Semaglutide is the generic ingredient in four branded drugs marketed by Novo and is included in four NDAs. There are forty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Semaglutide has four hundred and eighty-eight patent family members in thirty-eight countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Semaglutide

International Patents:	488
US Patents:	40
Tradenames:	4
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	470
Patent Applications:	2,758
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Semaglutide
What excipients (inactive ingredients) are in Semaglutide?	Semaglutide excipients list
DailyMed Link:	Semaglutide at DailyMed

Recent Clinical Trials for Semaglutide

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

Sponsor	Phase
First Affiliated Hospital of Wenzhou Medical University	PHASE2
St. James's Hospital, Ireland	PHASE2
Leiden University Medical Center	PHASE3

See all Semaglutide clinical trials

Generic filers with tentative approvals for SEMAGLUTIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	4MG/3ML	INJECTION;SOLUTION
⤷ Start Trial	⤷ Start Trial	2MG/3ML	INJECTION;SOLUTION
⤷ Start Trial	⤷ Start Trial	8MG/3ML	INJECTION;SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for Semaglutide

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

Anatomical Therapeutic Chemical (ATC) Classes for Semaglutide

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 SEMAGLUTIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WEGOVY	Tablets	semaglutide	1.5 mg, 4 mg and 9 mg	218316	1	2026-03-11
RYBELSUS	Tablets	semaglutide	1.5 mg, 4 mg and 9 mg	213051	1	2025-12-11
RYBELSUS	Tablets	semaglutide	3 mg, 7 mg and 14 mg	213051	1	2024-07-15
OZEMPIC	Injection	semaglutide	2 mg/3 mL	209637	1	2024-04-11
OZEMPIC	Injection	semaglutide	8 mg/3 mL	209637	1	2022-12-21
WEGOVY HD	Injection	semaglutide	0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL	215256	1	2022-10-20
OZEMPIC	Injection	semaglutide	2 mg/1.5 mL and 4 mg/3 mL	209637	7	2021-12-06

US Patents and Regulatory Information for Semaglutide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		DISCN	Yes	No	9,861,757	⤷ Start Trial	Y		Y	⤷ Start Trial
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-005	Dec 9, 2024		RX	Yes	Yes	12,396,953	⤷ Start Trial	Y			⤷ Start Trial
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-004	Dec 9, 2024		RX	Yes	Yes	12,396,953	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Semaglutide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	11,446,443	⤷ Start Trial
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	8,114,833	⤷ Start Trial
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	10,357,616	⤷ Start Trial
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	10,357,616	⤷ Start Trial
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	8,536,122	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for Semaglutide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for Semaglutide

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Country	Patent Number	Title	Estimated Expiration
Brazil	112020014624		⤷ Start Trial
Canada	2877056		⤷ Start Trial
China	103260608		⤷ Start Trial
South Korea	20140138873	ＧＬＰ-1 펩티드의 조성물 및 그것의 제조 (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)	⤷ Start Trial
Mexico	366405	USO DE PEPTIDOS GLP-1 DE ACCION PROLONGADA. (USE OF LONG-ACTING GLP-1 PEPTIDES.)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for Semaglutide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	22/2018	Austria	⤷ Start Trial	PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	1890018-3	Sweden	⤷ Start Trial	PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
1863839	661	Finland	⤷ Start Trial
1863839	18C1017	France	⤷ Start Trial	PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	C201830026	Spain	⤷ Start Trial	PRODUCT NAME: OZEMPIC-SEMAGLUTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1251; DATE OF AUTHORISATION: 20180208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1251; DATE OF FIRST AUTHORISATION IN EEA: 20180208
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.