RYBELSUS Drug Patent Profile
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When do Rybelsus patents expire, and what generic alternatives are available?
Rybelsus is a drug marketed by Novo and is included in one NDA. There are eleven patents protecting this drug.
This drug has one hundred and fifty-one patent family members in thirty countries.
The generic ingredient in RYBELSUS is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
DrugPatentWatch® Generic Entry Outlook for Rybelsus
Rybelsus was eligible for patent challenges on December 5, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 15, 2033. This may change due to patent challenges or generic licensing.
There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for RYBELSUS
International Patents: | 151 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 7 |
Patent Applications: | 938 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RYBELSUS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RYBELSUS |
What excipients (inactive ingredients) are in RYBELSUS? | RYBELSUS excipients list |
DailyMed Link: | RYBELSUS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RYBELSUS
Generic Entry Date for RYBELSUS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 RYBELSUS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
University of Colorado, Denver | Phase 2 |
Pfizer | Phase 2 |
Pharmacology for RYBELSUS
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for RYBELSUS
US Patents and Regulatory Information for RYBELSUS
RYBELSUS is protected by eleven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYBELSUS is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting RYBELSUS
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Oral dosing of GLP-1 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Compositions of GLP-1 peptides and preparation thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Acylated GLP-1 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Acylated GLP-1 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-001 | Sep 20, 2019 | RX | Yes | No | ⤷ 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 | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | 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 |
EU/EMA Drug Approvals for RYBELSUS
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 RYBELSUS
When does loss-of-exclusivity occur for RYBELSUS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13234496
Estimated Expiration: ⤷ Sign Up
Patent: 17251814
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014023374
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 68188
Estimated Expiration: ⤷ Sign Up
China
Patent: 4203266
Estimated Expiration: ⤷ Sign Up
Patent: 7812181
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181447
Estimated Expiration: ⤷ Sign Up
Patent: 0231060
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20767
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 27885
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Patent: 88857
Estimated Expiration: ⤷ Sign Up
Patent: 24475
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 39406
Estimated Expiration: ⤷ Sign Up
Patent: 62740
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4228
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 01158
Estimated Expiration: ⤷ Sign Up
Patent: 15512374
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 1146
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 3067
Estimated Expiration: ⤷ Sign Up
Patent: 14010685
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Patent: 88857
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 41198
Estimated Expiration: ⤷ Sign Up
Patent: 14141700
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 727
Estimated Expiration: ⤷ Sign Up
Patent: 460
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 27885
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1406250
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2072202
Estimated Expiration: ⤷ Sign Up
Patent: 2266299
Estimated Expiration: ⤷ Sign Up
Patent: 140138873
Estimated Expiration: ⤷ Sign Up
Patent: 200013078
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 90553
Estimated Expiration: ⤷ Sign Up
Patent: 52874
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 3976
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering RYBELSUS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I372629 | ⤷ Sign Up | |
Mexico | 345501 | COMPOSICIONES SOLIDAS QUE COMPRENDEN AGONISTA DE GLP-1 Y SAL DEL ACIDO N-(8-(2-HIDROXIBENZOIL)AMINO)CAPRILICO. (SOLID COMPOSITIONS COMPRISING A GLP-1 AGONIST AND A SALT OF N-(8-(2-HYDROXYBENZOYL)AMINO)CAPRYLIC ACID.) | ⤷ Sign Up |
Serbia | 56998 | ČVRSTE KOMPOZICIJE KOJE SADRŽE AGONIST GLP-1 I SO N-(8-(2-HIDROKSIBENZOIL)AMINO)KAPRILNE KISELINE (SOLID COMPOSITIONS COMPRISING A GLP-1 AGONIST AND A SALT OF N-(8-(2-HYDROXYBENZOYL)AMINO)CAPRYLIC ACID) | ⤷ Sign Up |
Slovenia | 3326620 | ⤷ Sign Up | |
Serbia | 64460 | KOMPOZICIJE GLP-1 PEPTIDA I NJIHOVA PRIPREMA (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF) | ⤷ Sign Up |
Mexico | 2007011220 | COMPUESTOS DE PEPTIDO 1 TIPO GLUCAGON ACILADOS. (ACYLATED GLP-1 COMPOUNDS.) | ⤷ Sign Up |
Denmark | 3326620 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RYBELSUS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1863839 | C01863839/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018 |
1863839 | 661 | Finland | ⤷ Sign Up | |
1863839 | 122018000075 | Germany | ⤷ Sign Up | PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208 |
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 |
1863839 | C201830026 | Spain | ⤷ Sign Up | 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 | 1890018-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212 |
1863839 | 300936 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |