SEMAGLUTIDE - Generic Drug Details

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

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

Semaglutide has four hundred and seventeen patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for SEMAGLUTIDE

International Patents:	417
US Patents:	35
Tradenames:	3
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	285
Patent Applications:	2,359
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

Generic Entry Dates for SEMAGLUTIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;SUBCUTANEOUS
Generic Entry Dates for SEMAGLUTIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for SEMAGLUTIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 SEMAGLUTIDE

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

Sponsor	Phase
Pichamol Jirapinyo, MD, MPH	Phase 4
Rijnstate Hospital	Phase 4
Second Xiangya Hospital of Central South University	Phase 1

See all SEMAGLUTIDE clinical trials

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	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	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	215256-005	Jun 4, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-005	Jun 4, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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	209637-002	Apr 9, 2019	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022	⤷ Sign Up	⤷ Sign Up
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	⤷ Sign Up	⤷ Sign Up
>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/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
>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
Chile	2021001430	Composiciones de glp-1 y sus usos. (divisional de solicitud 202000422)	⤷ Sign Up
Russian Federation	2020109402	КОМПОЗИЦИИ НА ОСНОВЕ GLP-1 И ПУТИ ИХ ПРИМЕНЕНИЯ	⤷ Sign Up
Australia	2018321157	GLP-1 compositions and uses thereof	⤷ Sign Up
Brazil	112014023374	composições de peptídeos de glp-1 e preparação das mesmas	⤷ Sign Up
>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	18C1017	France	⤷ Sign Up	PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	C01863839/01	Switzerland	⤷ Sign Up	PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839	SPC/GB18/023	United Kingdom	⤷ Sign Up	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	C201830026	Spain	⤷ Sign Up	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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