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Last Updated: July 19, 2024

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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 eight patents protecting this drug.

This drug has one hundred and sixty-one 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

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Summary for ORGOVYX
International Patents:161
US Patents:8
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
Drug patent expirations by year for ORGOVYX
Drug Prices for ORGOVYX

See drug prices for ORGOVYX

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

SponsorPhase
Yale UniversityPhase 2
University of Kansas Medical CenterPhase 2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPhase 2/Phase 3

See all ORGOVYX clinical trials

US Patents and Regulatory Information for ORGOVYX

ORGOVYX is protected by eight 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

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 ⤷  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 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 ⤷  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 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
Canada 2978223 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) ⤷  Sign Up
Taiwan I663171 ⤷  Sign Up
Turkey 201906318 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2004067535 ⤷  Sign Up
China 110312512 用于治疗子宫肌瘤和子宫内膜异位症的方法 (METHODS OF TREATING UTERINE FIBROIDS AND ENDOMETRIOSIS) ⤷  Sign Up
Hungary S2100052 ⤷  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 301158 Netherlands ⤷  Sign Up PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446 CR 2021 00048 Denmark ⤷  Sign Up PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446 122022000002 Germany ⤷  Sign Up PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446 672 Finland ⤷  Sign Up
1591446 CA 2021 00048 Denmark ⤷  Sign Up PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446 2022C/501 Belgium ⤷  Sign Up PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
>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.