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Views: 58 Author: Unibest Industrial Publish Time: 2024-04-11 Origin: Site
Query Drug：Semaglutide
Query Time：2024-08-26 09:30:00
*** Disclaimer *** The information provided here is sourced from resources such as Drugs.com, the Orange Book, etc., and is auto-generated by the Unibest Digital Center. The content is intended exclusively for pharmaceutical professionals. Unibest does NOT accept legal responsibility for ANY medical actions taken based on this information. ALWAYS consult with your doctor for medical advice. In addition, this product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
Semaglutide is the active ingredient in Ozempic, Wegovy, and Rybelsus. Semaglutide is used for weight loss in specific patients, and also to lower blood sugar levels, and to reduce the risk of major cardiovascular events such as heart attack or stroke in certain patients. Semaglutide is a GLP-1 agonist that works by increasing insulin release, lowering the amount of glucagon released, delaying gastric emptying, and reducing appetite.
Semaglutide weight loss brand is Wegovy is the only semaglutide brand that is FDA brand approved for weight loss.
Semaglutide injections (Ozempic and Wegovy) are given as subcutaneous injections once a week. Rybelsus is a tablet that you take once a day in the morning, 30 minutes before eating, drinking, or taking any other medicines. You may eat, drink, or take oral medicine 30 minutes after taking Rybelsus.
Semaglutide is not for use in people with type 1 diabetes.
Semaglutide is not available as a generic medicine. Each of the different brands of semaglutide (Wegovy, Ozempic, Rybelus) are made by Novo Nordisk and are FDA-approved for different conditions.
Thyroid Neoplasms
Multiple Endocrine Neoplasia Type 2b
Multiple Endocrine Neoplasia Type 2a
Carcinoma, Neuroendocrine
Drug Hypersensitivity
Source: MEDRT
Source: MEDRT
Source: MEDRT
Source DAILYMED
Source FDASPL
Source DAILYMED
Source FDASPL
[Last update] 2024-08-09
Semaglutide's Innovator is NOVO NORDISK INC
The unique dosage forms from the innovator include：1. SOLUTION;SUBCUTANEOUS；2. TABLET;ORAL.
| Index | Route | Brand Name | Labeler | Approval Date | Dosage |
|---|---|---|---|---|---|
| 1 | SOLUTION;SUBCUTANEOUS | WEGOVY | NOVO NORDISK INC | Jun 4, 2021 | 2.4MG/0.75ML (2.4MG/0.75ML) |
| 2 | SOLUTION;SUBCUTANEOUS | OZEMPIC | NOVO NORDISK INC | Apr 9, 2019 | 4MG/3ML (1.34MG/ML) |
| 3 | SOLUTION;SUBCUTANEOUS | WEGOVY | NOVO NORDISK INC | Jun 4, 2021 | 1.7MG/0.75ML (1.7MG/0.75ML) |
| 4 | SOLUTION;SUBCUTANEOUS | OZEMPIC | NOVO NORDISK INC | Dec 5, 2017 | 2MG/1.5ML (1.34MG/ML) |
| 5 | SOLUTION;SUBCUTANEOUS | WEGOVY | NOVO NORDISK INC | Jun 4, 2021 | 0.5MG/0.5ML (0.5MG/0.5ML) |
| 6 | SOLUTION;SUBCUTANEOUS | OZEMPIC | NOVO NORDISK INC | Oct 6, 2022 | 2MG/3ML (0.68MG/ML) |
| 7 | SOLUTION;SUBCUTANEOUS | WEGOVY | NOVO NORDISK INC | Jun 4, 2021 | 1MG/0.5ML (1MG/0.5ML) |
| 8 | SOLUTION;SUBCUTANEOUS | OZEMPIC | NOVO NORDISK INC | Mar 28, 2022 | 8MG/3ML (2.68MG/ML) |
| 9 | SOLUTION;SUBCUTANEOUS | WEGOVY | NOVO NORDISK INC | Jun 4, 2021 | 0.25MG/0.5ML (0.25MG/0.5ML) |
| 10 | TABLET;ORAL | RYBELSUS | NOVO NORDISK INC | Sep 20, 2019 | 14MG |
| 11 | TABLET;ORAL | RYBELSUS | NOVO NORDISK INC | Sep 20, 2019 | 3MG |
| 12 | TABLET;ORAL | RYBELSUS | NOVO NORDISK INC | Sep 20, 2019 | 7MG |
This drug still has 35 effective patents.
| Patent Number | Submission Date | Expiration Date | Drug Substance Patent? | Drug Product Patent? |
|---|---|---|---|---|
| 8129343 | Dec 20, 2017 | Dec 5, 2031 | Y | Y |
| 9687611 | Dec 20, 2017 | Feb 27, 2027 | Y | |
| 9457154 | Dec 20, 2017 | Sep 27, 2027 | Y | |
| 9132239 | Dec 20, 2017 | Feb 1, 2032 | Y | |
| 9278123 | Oct 15, 2019 | Dec 16, 2031 | Y | |
| 10278923 | Oct 15, 2019 | May 2, 2034 | ||
| 10086047 | Oct 15, 2019 | Dec 16, 2031 | Y | |
| 8114833 | Sep 24, 2020 | Aug 13, 2025 | Y | |
| 9108002 | Dec 21, 2020 | Jan 20, 2026 | Y | |
| 9775953 | Dec 21, 2020 | Jul 17, 2026 | Y | |
| 7762994 | Dec 21, 2020 | May 23, 2024 | Y | |
| 9616180 | Dec 21, 2020 | Jan 20, 2026 | Y | |
| 10220155 | Dec 21, 2020 | Jul 17, 2026 | Y | |
| 10933120 | Mar 31, 2021 | Mar 15, 2033 | Y | |
| 10960052 | Apr 26, 2021 | Dec 16, 2031 | Y | |
| 10888605 | Jun 30, 2021 | Aug 24, 2038 | Y | |
| 9764003 | Jun 30, 2021 | Jun 21, 2033 | ||
| 11097063 | Sep 21, 2021 | Jul 17, 2026 | Y | |
| 8536122 | Apr 29, 2022 | Mar 20, 2026 | Y | Y |
| 8684969 | Apr 29, 2022 | Oct 20, 2025 | Y | |
| 11311679 | May 20, 2022 | Jan 20, 2026 | Y | |
| 11318191 | Jun 29, 2022 | Feb 17, 2041 | Y | |
| 11382957 | Jul 26, 2022 | Dec 16, 2031 | Y | |
| 11446443 | Oct 7, 2022 | Oct 20, 2025 | Y | |
| 10335462 | Nov 14, 2022 | Jun 21, 2033 | Y | |
| 10357616 | Nov 14, 2022 | Jan 20, 2026 | Y | |
| 10376652 | Nov 14, 2022 | Jan 20, 2026 | Y | |
| 8920383 | Nov 14, 2022 | Jul 17, 2026 | Y | |
| 9861757 | Nov 14, 2022 | Jan 20, 2026 | Y | |
| RE46363 | Nov 14, 2022 | Aug 3, 2026 | Y | |
| 11752198 | Oct 10, 2023 | Aug 24, 2038 | Y | |
| 11759501 | Oct 12, 2023 | Mar 15, 2033 | Y | |
| 11759502 | Oct 12, 2023 | Mar 15, 2033 | Y | |
| 11759503 | Oct 12, 2023 | Mar 15, 2033 | Y | |
| 12029779 | Jul 9, 2024 | Oct 10, 2038 |
The innovator NOVO NORDISK INC's portolio contains products with the following 6 API(s)： METFORMIN HYDROCHLORIDE; REPAGLINIDE, NEDOSIRAN SODIUM, LIRAGLUTIDE, SEMAGLUTIDE, ESTRADIOL, MACIMORELIN ACETATE
The above products are related to 11 diseases： Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2, Hyperoxaluria, Primary, Hot Flashes, Osteoporosis, Postmenopausal, Hypogonadism, Breast Neoplasms, Prostatic Neoplasms, Menorrhagia, Primary Ovarian Insufficiency, Menopause, Premature
