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.
Summary for semaglutide
International Patents: | 365 |
US Patents: | 32 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 201 |
Patent Applications: | 2,591 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for semaglutide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mayo Clinic | Phase 2 |
United States Department of Defense | Phase 2 |
Virginia Commonwealth University | Phase 2 |
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
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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