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 four branded drugs marketed by Novo and is included in four NDAs. There are thirty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Semaglutide has four hundred and eighty-six patent family members in thirty-eight countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for Semaglutide
| International Patents: | 486 |
| US Patents: | 39 |
| Tradenames: | 4 |
| Applicants: | 1 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 30 |
| Clinical Trials: | 470 |
| Patent Applications: | 2,758 |
| 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 |
|---|---|
| First Affiliated Hospital of Wenzhou Medical University | PHASE2 |
| St. James's Hospital, Ireland | PHASE2 |
| Leiden University Medical Center | PHASE3 |
Generic filers with tentative approvals for SEMAGLUTIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 2MG/3ML | INJECTION;SOLUTION |
| ⤷ Start Trial | ⤷ Start Trial | 2MG/1.5ML | INJECTION;SOLUTION |
| ⤷ Start Trial | ⤷ Start Trial | 4MG/3ML | INJECTION;SOLUTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|
| RYBELSUS | Tablets | semaglutide | 1.5 mg, 4 mg and 9 mg | 213051 | 1 | 2025-12-11 |
| 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 HD | 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 | OZEMPIC | semaglutide | TABLET;ORAL | 213051-004 | Dec 9, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novo | WEGOVY | semaglutide | TABLET;ORAL | 218316-003 | Dec 22, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novo | WEGOVY | semaglutide | SOLUTION;SUBCUTANEOUS | 215256-005 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | 209637-003 | Mar 28, 2022 | ⤷ Start Trial | ⤷ Start Trial |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-003 | Mar 28, 2022 | ⤷ Start Trial | ⤷ Start Trial |
| Novo | WEGOVY | semaglutide | SOLUTION;SUBCUTANEOUS | 215256-005 | Jun 4, 2021 | ⤷ Start Trial | ⤷ Start 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/005422Wegovy 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/004174Treatment 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/004953Rybelsus 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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 7221694 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2014005858 | ⤷ Start Trial | |
| Russian Federation | 2013131913 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Semaglutide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1863839 | C201830026 | Spain | ⤷ Start Trial | 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 | SPC/GB18/023 | United Kingdom | ⤷ Start 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 | 2018/017 | Ireland | ⤷ Start 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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