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^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing NDA: 214621 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
Emory University	Phase 4
National Cancer Institute (NCI)	Phase 4
National Cancer Institute (NCI)	Phase 2

See all ORGOVYX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ORGOVYX

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

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

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

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Glossary

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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

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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.

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Country	Patent Number	Title	Estimated Expiration
South Africa	200506611	Thienopyrimidine compounds and use thereof	See Plans and Pricing
European Patent Office	1591446	Composés 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

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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