Details for New Drug Application (NDA): 214621

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NDA 214621 describes ORGOVYX, which is a drug marketed by Sumitomo Pharma and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ORGOVYX profile page.

The generic ingredient in ORGOVYX is relugolix. One supplier is listed for this compound. Additional details are available on the relugolix profile page.

Summary for 214621

Tradename:	ORGOVYX
Applicant:	Sumitomo Pharma
Ingredient:	relugolix
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 214621

Generic Entry Date for 214621^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for NDA: 214621

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

Suppliers and Packaging for NDA: 214621

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORGOVYX	relugolix	TABLET;ORAL	214621	NDA	Sumitomo Pharma America, Inc.	72974-120	72974-120-01	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)
ORGOVYX	relugolix	TABLET;ORAL	214621	NDA	Sumitomo Pharma America, Inc.	72974-120	72974-120-95	16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	120MG
Approval Date:	Dec 18, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 18, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Feb 25, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 29, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER

Expired US Patents for NDA 214621

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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