SEMAGLUTIDE - Generic Drug Details

What are the generic drug sources for semaglutide and what is the scope of freedom to operate?

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

Semaglutide has four hundred and eighty-six 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:	486
US Patents:	39
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

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

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

Constraining patent/regulatory exclusivity:

10,933,120

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF NONCIRRHOTIC METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH), FORMERLYKNOWN AS NONALCOHOLIC STEATOHEPATITIS (NASH), WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) IN ADULTS

Dosage:

SOLUTION;SUBCUTANEOUS

Constraining patent/regulatory exclusivity:

11,382,957

Dosage:

TABLET;ORAL

^*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 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
		2MG/3ML	INJECTION;SOLUTION
		2MG/1.5ML	INJECTION;SOLUTION
		4MG/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
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

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	209637-002	Apr 9, 2019		RX	Yes	Yes	9,616,180		Y		Y
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-005	Dec 9, 2024		RX	Yes	Yes	11,833,248		Y
Novo	WEGOVY	semaglutide	TABLET;ORAL	218316-001	Dec 22, 2025		RX	Yes	Yes	11,833,248		Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	Yes	11,759,503		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	9,687,611		Y		Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	12,514,822
Novo	WEGOVY	semaglutide	TABLET;ORAL	218316-003	Dec 22, 2025		RX	Yes	Yes

Expired US Patents for SEMAGLUTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	9,861,757
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	8,684,969
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-005	Jun 4, 2021	8,536,122
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022	9,861,757
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	9,616,180
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	8,114,833
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	11,311,679

EU/EMA Drug Approvals for SEMAGLUTIDE

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 SEMAGLUTIDE

Country	Patent Number	Title	Estimated Expiration
China	115135305
World Intellectual Property Organization (WIPO)	2012080471
World Intellectual Property Organization (WIPO)	2021144477
Japan	2022513346	ＧＬＰ－１組成物およびその使用
South Korea	102665710
Brazil	112015026325	dosagem oral de compostos glp-1
Japan	4585037

Supplementary Protection Certificates for SEMAGLUTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	661	Finland
1863839	2018/017	Ireland		PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	300936	Netherlands		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	C201830026	Spain		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
1863839	CR 2018 00019	Denmark		PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839	SPC/GB18/023	United Kingdom		PRODUCT NAME: SEMAGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1251 (NI) 20180208; UK PLGB 04668/0331 20180208; UK PLGB 04668/0332 20180208; UK PLGB 04668/0333 20180208
1863839	18C1017	France		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212