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Semaglutide - Generic Drug Details

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

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

Semaglutide has two hundred and seventy-eight patent family members in twenty-eight countries.

Two suppliers are listed for this compound.

Summary for semaglutide

International Patents:	278
US Patents:	25
Tradenames:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	3
Clinical Trials:	119
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for semaglutide
DailyMed Link:	semaglutide at DailyMed

Recent Clinical Trials for semaglutide

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
The University of Texas Health Science Center, Houston	Phase 2
University of Copenhagen	N/A

See all semaglutide clinical trials

Recent Litigation for semaglutide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.	2017-03-03
SMITH v. NOVO NORDISK INC.	2016-08-08

See all semaglutide litigation

PTAB Litigation

Petitioner	Date
Mylan Institutional LLC	2019-12-19

See all semaglutide litigation

Pharmacology for semaglutide

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

Synonyms for semaglutide

53AXN4NNHX

910463-68-2

910463-93-3

EX-A2424

GTPL9724

NN 9535

NN-9535

NN9535

NNC 0113-0217

Ozempic

Semaglutide [USAN:INN]

Sermaglutide

UNII-53AXN4NNHX

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	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	No			Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		RX	Yes	Yes			Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	No			Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	No			Y	Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		RX	Yes	Yes			Y	Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	No

International Patents for semaglutide

Country	Patent Number	Estimated Expiration
Japan	2013063984
Japan	2008517233
Portugal	1351732
European Patent Office	1909871
South Africa	200703706
World Intellectual Property Organization (WIPO)	2014177683
Canada	2821886

Supplementary Protection Certificates for semaglutide

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	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	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	1890018-3	Sweden		PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
1863839	2018C/016	Belgium		PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839	18C1017	France		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208