You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for New Drug Application (NDA): 021782


✉ Email this page to a colleague

« Back to Dashboard


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-four 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 ActionMelatonin 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:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jul 22, 2005TE:ABRLD:Yes

Expired US Patents for NDA 021782

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.