ORGOVYX Drug Patent Profile
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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 and one Paragraph IV challenge.
This drug has one hundred and seventy-nine patent family members in thirty-seven 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 was eligible for patent challenges on December 18, 2024.
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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
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Summary for ORGOVYX
International Patents: | 179 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 9 |
Patent Applications: | 252 |
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
Generic Entry Date for ORGOVYX*:
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 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., FAPCR, Sponsor-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 ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Try for Free | ⤷ Try for Free |
>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: ⤷ Try for Free
Brazil
Patent: 2017018173
Patent: comprimido, método de estabilização, e, preparação sólida
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 78223
Patent: PREPARATION SOLIDE (SOLID PREPARATION)
Estimated Expiration: ⤷ Try for Free
China
Patent: 7249590
Patent: 固体制剂 (Solid preparation)
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0230613
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 26118
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 63110
Estimated Expiration: ⤷ Try for Free
Patent: 33847
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 63110
Patent: PRÉPARATION SOLIDE (SOLID PREPARATION)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Patent: 54708
Patent: UNE COMPRIMÉ CONTENANT UN DÉRIVÉ DE METHOXYURÉE ET DES PARTICULES DE MANNITOL (A TABLET COMPRISING A METHOXYUREA DERIVATIVE AND MANNITOL PARTICLES)
Estimated Expiration: ⤷ Try for Free
Finland
Patent: 63110
Estimated Expiration: ⤷ Try for Free
Patent: 33847
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 62269
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 2016136849
Patent: 固形製剤
Estimated Expiration: ⤷ Try for Free
Patent: 30978
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 63110
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 0680
Patent: SOLID PREPARATION
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 3225
Patent: PREPARADO SÓLIDO. (SOLID PREPARATION)
Estimated Expiration: ⤷ Try for Free
Patent: 17010945
Patent: PREPARACION SOLIDA. (SOLID PREPARATION.)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Poland
Patent: 63110
Estimated Expiration: ⤷ Try for Free
Patent: 33847
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 63110
Estimated Expiration: ⤷ Try for Free
San Marino
Patent: 02300221
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 377
Patent: TABLETA KOJA SADRŽI DERIVAT METOKSIUREE I ČESTICE MANITOLA (A TABLET COMPRISING A METHOXYUREA DERIVATIVE AND MANNITOL PARTICLES)
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 63110
Estimated Expiration: ⤷ Try for Free
Patent: 33847
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 50995
Estimated Expiration: ⤷ Try for Free
Patent: 88678
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 44224
Estimated Expiration: ⤷ Try for Free
Patent: 1639575
Patent: Solid preparation
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Poland | 214756 | ⤷ Try for Free | |
Israel | 254132 | 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) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2018060463 | ⤷ Try for Free | |
Brazil | 112019006228 | tratamento de câncer de próstata | ⤷ Try for Free |
China | 110248661 | 前列腺癌的治疗 (TREATMENT OF PROSTATE CANCER) | ⤷ Try for Free |
New Zealand | 752916 | Methods of treating uterine fibroids and endometriosis | ⤷ Try for Free |
Poland | 4233847 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORGOVYX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1591446 | 2190051-9 | Sweden | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720 |
1591446 | C 2021 047 | Romania | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716 |
1591446 | LUC00240 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
1591446 | PA2021529 | Lithuania | ⤷ Try for Free | PRODUCT NAME: RELUGOLIKSAS ARBA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
1591446 | CR 2021 00048 | Denmark | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720 |
1591446 | 301158 | Netherlands | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720 |
1591446 | 21C1056 | France | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of ORGOVYX
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