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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 two branded drugs marketed by Novo and is included in two NDAs. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Semaglutide has two hundred and eighty-seven patent family members in twenty-eight countries.
Two suppliers are listed for this compound.
Summary for semaglutide
| International Patents: | 287 |
| US Patents: | 25 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 123 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for semaglutide |
| DailyMed Link: | semaglutide at DailyMed |
Recent Clinical Trials for semaglutide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| The University of Texas Health Science Center, Houston | Phase 2 |
| Göteborg University | Phase 2 |
Pharmacology for semaglutide
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
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 | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | 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 |
International Patents for semaglutide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1351732 | Start Trial |
| Germany | 60328927 | Start Trial |
| Denmark | 3300721 | Start Trial |
| South Korea | 101925620 | Start Trial |
| Norway | 337946 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for semaglutide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1863839 | 22/2018 | Austria | Start Trial | PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212 |
| 1863839 | 300936 | Netherlands | Start Trial | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208 |
| 1863839 | 18C1017 | France | Start Trial | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208 |
| 1863839 | 132018000000262 | Italy | Start Trial | PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212 |
| 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 |
| >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.
ISSN: 2162-2639
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