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Last Updated: December 6, 2022

Semaglutide - Generic Drug Details


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

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

Two suppliers are listed for this compound.

Recent Clinical Trials for semaglutide

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

SponsorPhase
AZ DeltaPhase 3
UZAPhase 3
Jessa HospitalPhase 3

See all semaglutide clinical trials

Pharmacology for semaglutide
Paragraph IV (Patent) Challenges for SEMAGLUTIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 209637-001 Dec 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-002 Jun 4, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-002 Jun 4, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-003 Jun 4, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/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 exercise, , , as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, in 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

Country Patent Number Title Estimated Expiration
Poland 1804865 See Plans and Pricing
Croatia P20180425 See Plans and Pricing
Spain 2661676 See Plans and Pricing
Canada 2601784 COMPOSES DE GLP-1 ACYLES (ACYLATED GLP-1 COMPOUNDS) See Plans and Pricing
Spain 2361563 See Plans and Pricing
China 104402989 ACYLATED GLP-1 COMPOUNDS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for semaglutide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 122018000075 Germany See Plans and Pricing PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 CR 2018 00019 Denmark See Plans and Pricing PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839 C01863839/01 Switzerland See Plans and Pricing PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839 661 Finland See Plans and Pricing
1863839 22/2018 Austria See Plans and Pricing PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 2018C/016 Belgium See Plans and Pricing PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
>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. 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.