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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
UBS
Cerilliant
US Army
Queensland Health
Accenture
Fish and Richardson
QuintilesIMS
Moodys

Generated: February 21, 2018

DrugPatentWatch Database Preview

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 six suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ROZEREM profile page.

The generic ingredient in ROZEREM is ramelteon. There are two drug master file entries for this compound. 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:1
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
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 Rebel Distributors Corp 21695-183 E 21695-183-30
ROZEREM ramelteon TABLET;ORAL 021782 NDA Physicians Total Care, Inc. 54868-5649 E 54868-5649-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jul 22, 2005TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 22, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

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Covington
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Federal Trade Commission
Accenture
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Medtronic
Mallinckrodt
Cerilliant

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