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Last Updated: October 1, 2022

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 Myovant Sciences and is included in one NDA. There are six patents protecting this drug.

This drug has ninety-five patent family members in thirty-three countries.

The generic ingredient in ORGOVYX is relugolix. 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:95
US Patents:6
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 43
Clinical Trials: 4
Patent Applications: 119
What excipients (inactive ingredients) are in ORGOVYX?ORGOVYX excipients list
DailyMed Link:ORGOVYX at DailyMed
Drug patent expirations by year for ORGOVYX
DrugPatentWatch® Estimated Generic Entry Opportunity 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
Emory UniversityPhase 4
National Cancer Institute (NCI)Phase 4
National Cancer Institute (NCI)Phase 2

See all ORGOVYX clinical trials

US Patents and Regulatory Information for ORGOVYX

ORGOVYX is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORGOVYX is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of prostate cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER

Treatment of prostate cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER

Thienopyrimidine compounds and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Thienopyrimidine compounds and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Myovant Sciences ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Myovant Sciences ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Myovant Sciences ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2017018173
Estimated Expiration: See Plans and Pricing

Canada

Patent: 78223
Estimated Expiration: See Plans and Pricing

China

Patent: 7249590
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63110
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4132
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2016136849
Estimated Expiration: See Plans and Pricing

Patent: 30978
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0680
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17010945
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5026
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44224
Estimated Expiration: See Plans and Pricing

Patent: 1639575
Estimated Expiration: See Plans and Pricing

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
South Africa 200506611 Thienopyrimidine compounds and use thereof See Plans and Pricing
European Patent Office 1591446 Compos├ęs de thienopyrimidine et utilisation (Thienopyrimidine compounds and use thereof) See Plans and Pricing
South Korea 20050096171 THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORGOVYX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591446 PA2021529 Lithuania See Plans and Pricing PRODUCT NAME: RELUGOLIKSAS ARBA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446 672 Finland See Plans and Pricing
1591446 122022000002 Germany See Plans and Pricing PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
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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.