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Last Updated: March 29, 2024

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orgovyx Drug Patent Profile


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Which patents cover Orgovyx, and what generic alternatives are available?

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 fifty-eight 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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  Try a Trial

Summary for orgovyx
International Patents:158
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 6
Patent Applications: 121
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
PfizerPhase 2
Dana-Farber Cancer InstitutePhase 2
Myovant Sciences GmbHPhase 2

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatment of prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER

Treatment of prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Thienopyrimidine compounds and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Thienopyrimidine compounds and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017018173
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 78223
Estimated Expiration: ⤷  Try a Trial

China

Patent: 7249590
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0230613
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 26118
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

Patent: 33847
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 62269
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4132
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2016136849
Estimated Expiration: ⤷  Try a Trial

Patent: 30978
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 0680
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 17010945
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5026
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 377
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 63110
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 50995
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 44224
Estimated Expiration: ⤷  Try a Trial

Patent: 1639575
Estimated Expiration: ⤷  Try a Trial

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
World Intellectual Property Organization (WIPO) 2004067535 ⤷  Try a Trial
Hungary E044048 ⤷  Try a Trial
Croatia P20230613 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for orgovyx

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591446 SPC/GB21/065 United Kingdom ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720
1591446 C 2021 047 Romania ⤷  Try a Trial 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 51/2021 Austria ⤷  Try a Trial PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 (MITTEILUNG) 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.