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Last Updated: August 19, 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-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Semaglutide has three hundred and sixty-five 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
Mayo ClinicPhase 2
United States Department of DefensePhase 2
Virginia Commonwealth UniversityPhase 2

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 RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No See Plans and Pricing See Plans and Pricing 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 209637-002 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
>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
Brazil PI0607012 dispositivo de injeção See Plans and Pricing
Russian Federation 2014141700 КОМПОЗИЦИИ GLP-1 ПЕПТИДОВ И ИХ ПОЛУЧЕНИЕ See Plans and Pricing
Turkey 201906789 See Plans and Pricing
Spain 2243721 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2021144477 See Plans and Pricing
Russian Federation 2506957 МЕХАНИЗМ УМЕНЬШЕНИЯ УСТАНОВЛЕННОЙ ДОЗЫ ДЛЯ ВЗВОДИМОГО ШПРИЦА-РУЧКИ (MECHANISM OF REDUCING ESTABLISHED DOSE FOR COCKED PREFILLED SYRINGE) 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 C01863839/01 Switzerland See Plans and Pricing PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839 SPC/GB18/023 United Kingdom See Plans and Pricing 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 See Plans and Pricing 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 2018C/016 Belgium See Plans and Pricing PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 661 Finland See Plans and Pricing
1863839 CR 2018 00019 Denmark See Plans and Pricing PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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