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Last Updated: April 13, 2024

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 ninety-one patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for semaglutide
Generic Entry Dates for semaglutide*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for semaglutide*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for semaglutide*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Washington University School of MedicinePhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Merck Sharp & Dohme LLCPhase 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 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

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-005 Jun 4, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 ⤷  Try a Trial ⤷  Try a Trial
>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 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

Supplementary Protection Certificates for semaglutide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 22/2018 Austria ⤷  Try a Trial PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 18C1017 France ⤷  Try a Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 SPC/GB18/023 United Kingdom ⤷  Try a Trial 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 661 Finland ⤷  Try a Trial
1863839 2018/017 Ireland ⤷  Try a Trial PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
>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.