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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 021782

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NDA 021782 describes ROZEREM, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the ROZEREM profile page.

The generic ingredient in ROZEREM is ramelteon. There are three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

Summary for 021782

Tradename:	ROZEREM
Applicant:	Takeda Pharms Usa
Ingredient:	ramelteon
Patents:	0

Pharmacology for NDA: 021782

Mechanism of Action	Melatonin Receptor Agonists

Suppliers and Packaging for NDA: 021782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROZEREM	ramelteon	TABLET;ORAL	021782	NDA	Takeda Pharmaceuticals America, Inc.	64764-805	64764-805-10	100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)
ROZEREM	ramelteon	TABLET;ORAL	021782	NDA	Takeda Pharmaceuticals America, Inc.	64764-805	64764-805-22	6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Jul 22, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021782

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	6,034,239	⤷ Get Started Free
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005	10,098,866	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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