ORGOVYX Drug Patent Profile
✉ Email this page to a colleague
When do Orgovyx patents expire, and when can generic versions of Orgovyx launch?
Orgovyx is a drug marketed by Sumitomo Pharma and is included in one NDA. There are nine patents protecting this drug.
This drug has one hundred and sixty-two patent family members in thirty-six countries.
The generic ingredient in ORGOVYX is relugolix. One supplier is listed for this compound. Additional details are available on the relugolix profile page.
DrugPatentWatch® Generic Entry Outlook for Orgovyx
Orgovyx will be eligible for patent challenges on December 18, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 25, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ORGOVYX?
- What are the global sales for ORGOVYX?
- What is Average Wholesale Price for ORGOVYX?
Summary for ORGOVYX
| International Patents: | 162 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Clinical Trials: | 9 |
| Patent Applications: | 103 |
| Drug Prices: | Drug price information for ORGOVYX |
| What excipients (inactive ingredients) are in ORGOVYX? | ORGOVYX excipients list |
| DailyMed Link: | ORGOVYX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ORGOVYX
*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 ORGOVYX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yale University | Phase 2 |
| University of Kansas Medical Center | Phase 2 |
| Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair | Phase 2/Phase 3 |
Pharmacology for ORGOVYX
US Patents and Regulatory Information for ORGOVYX
ORGOVYX is protected by nine US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORGOVYX 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 ORGOVYX
Solid preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatment of prostate cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Treatment of prostate cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER THAT IS SEX-HORMONE-DEPENDENT
FDA Regulatory Exclusivity protecting ORGOVYX
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 ORGOVYX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ORGOVYX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Accord Healthcare S.L.U. | Orgovyx | relugolix | EMEA/H/C/005353 Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. |
Authorised | no | no | no | 2022-04-29 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ORGOVYX
When does loss-of-exclusivity occur for ORGOVYX?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 16224503
Patent: Solid preparation
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017018173
Patent: comprimido, método de estabilização, e, preparação sólida
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 78223
Patent: FORMULATIONS DE N-(4-(1-(2,6-DIFLUOROBENZYL)-5-((DIMETHYLAMINE)METHYL)-3-(6-METHOXY-3-PYRIDAZINYL)-2,4-DIOXO-1,2,3,4-TETRAHYDROTHIENO[2,3-D]PYRIMIDINE-6-YL)PHENYLE)-N'-METHOXYUREE (FORMULATIONS OF N-(4-(1-(2,6-DIFLUOROBENZYL)-5-((DIMETHYL AMINO)METHYL)-3-(6-METHOXY-3-PYRIDAZINYL)-2,4-DIOXO-1,2,3,4-TETRAHYDROTHIENO[2,3-D]PYRIMIDIN-6-YL)PHENYL)-N'-METHOXYUREA)
Estimated Expiration: ⤷ Sign Up
China
Patent: 7249590
Patent: 固体制剂 (Solid preparation)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0230613
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 26118
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 63110
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 63110
Patent: PRÉPARATION SOLIDE (SOLID PREPARATION)
Estimated Expiration: ⤷ Sign Up
Patent: 33847
Patent: UNE COMPRIMÉ CONTENANT UN DÉRIVÉ DE METHOXYURÉE ET DES PARTICULES DE MANNITOL (A TABLET COMPRISING A METHOXYUREA DERIVATIVE AND MANNITOL PARTICLES)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 63110
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 62269
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4132
Patent: תכשיר מוצק של נ-(4-(1(2,6-דיפלורובנזיל)-5-))דימתילאמינו)מתיל)-3-(6-מתוקסי-3-פירידאזיניל)-2,4-דיוקסי-1,2,3,4-טטרההידרותיאנו[2,3-ד]פירימידין-6-יל)פניל)-נ'-מתוקסיוראה או מלח שלה (Solid preparation of n-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-n’-methoxyurea or a salt thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2016136849
Patent: 固形製剤
Estimated Expiration: ⤷ Sign Up
Patent: 30978
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 63110
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 0680
Patent: SOLID PREPARATION
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17010945
Patent: PREPARACION SOLIDA. (SOLID PREPARATION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5026
Patent: Solid preparations of n-(4-(1-(2,6-difluorobenzyl)-5-((dimethyl amino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidine-6-yl)phenyl)-n’-methoxyurea or a salt thereof, and methods of preparing same
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 63110
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 63110
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 377
Patent: TABLETA KOJA SADRŽI DERIVAT METOKSIUREE I ČESTICE MANITOLA (A TABLET COMPRISING A METHOXYUREA DERIVATIVE AND MANNITOL PARTICLES)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 63110
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 50995
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 44224
Estimated Expiration: ⤷ Sign Up
Patent: 1639575
Patent: Solid preparation
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 ORGOVYX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2913753 | ⤷ Sign Up | |
| Spain | 2724206 | ⤷ Sign Up | |
| Israel | 169869 | THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF | ⤷ Sign Up |
| South Korea | 20050096171 | THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORGOVYX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1591446 | 122022000002 | Germany | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
| 1591446 | PA2021529 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RELUGOLIKSAS ARBA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
| 1591446 | LUC00240 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
| 1591446 | 2190051-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
