ORGOVYX Drug Patent Profile

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 seven patents protecting this drug.

This drug has one hundred and eleven patent family members in thirty-four 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

Summary for ORGOVYX

International Patents:	111
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
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

See drug prices for ORGOVYX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORGOVYX

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
Pfizer	Phase 2
Dana-Farber Cancer Institute	Phase 2
Myovant Sciences GmbH	Phase 2

See all ORGOVYX clinical trials

Pharmacology for ORGOVYX

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

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 seven US patents and one FDA Regulatory Exclusivity.

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

FDA Regulatory Exclusivity protecting ORGOVYX

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
Myovant Sciences	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes				Y
Myovant Sciences	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes

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

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

Brazil

Canada

China

Denmark

European Patent Office

Finland

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Taiwan

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
Morocco	46353	MÉTHODES DE TRAITEMENT DE L'INFERTILITÉ FÉMININE
Netherlands	301158
European Patent Office	3518952	MÉTHODES DE TRAITEMENT DE L'INFERTILITÉ FÉMININE (METHODS OF TREATING FEMALE INFERTILITY)

Supplementary Protection Certificates for ORGOVYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	C202130069	Spain		PRODUCT NAME: RELUGOLIX O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716
1591446	C 2021 047	Romania		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	PA2021529	Lithuania		PRODUCT NAME: RELUGOLIKSAS ARBA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1565 20210716