SEMAGLUTIDE - Generic Drug Details
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What are the generic drug sources for semaglutide and what is the scope of freedom to operate?
Semaglutide
is the generic ingredient in three branded drugs marketed by Novo and is included in three NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Semaglutide has four hundred and seventeen patent family members in thirty-nine countries.
Two suppliers are listed for this compound.
Summary for SEMAGLUTIDE
International Patents: | 417 |
US Patents: | 35 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 285 |
Patent Applications: | 2,359 |
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 |
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
Sponsor | Phase |
---|---|
Pichamol Jirapinyo, MD, MPH | Phase 4 |
Rijnstate Hospital | Phase 4 |
Second Xiangya Hospital of Central South University | Phase 1 |
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 | 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 | 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 | WEGOVY | semaglutide | SOLUTION;SUBCUTANEOUS | 215256-003 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-002 | Sep 20, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-002 | Apr 9, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-004 | Oct 6, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 | 209637-002 | Apr 9, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-004 | Oct 6, 2022 | ⤷ Sign Up | ⤷ Sign Up |
Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-004 | Oct 6, 2022 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
International Patents for SEMAGLUTIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 112480 | COMPOSICIONES DE GLP-1 Y SUS USOS | ⤷ Sign Up |
Taiwan | 202140063 | Pharmaceutical formulations | ⤷ Sign Up |
Russian Federation | 2401134 | ИНЪЕКЦИОННОЕ УСТРОЙСТВО С МЕХАНИЗМОМ ОБРАТНОЙ СВЯЗИ ДЛЯ СООБЩЕНИЯ О ЗАВЕРШЕНИИ ВВЕДЕНИЯ ДОЗЫ ПРЕПАРАТА (INJECTION DEVICE WITH FEEDBACK MECHANISM FOR DOSING TERMINATION REPORT) | ⤷ Sign Up |
China | 101227942 | Syringe device with a dose limiting mechanism and an additional safety mechanism | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SEMAGLUTIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1863839 | 1890018-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212 |
1863839 | 132018000000262 | Italy | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212 |
1863839 | C01863839/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018 |
1863839 | SPC/GB18/023 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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