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Last Updated: October 2, 2023

ROZEREM Drug Patent Profile

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When do Rozerem patents expire, and what generic alternatives are available?

Rozerem is a drug marketed by Takeda Pharms Usa and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Rozerem

A generic version of ROZEREM was approved as ramelteon by DR REDDYS LABS SA on July 26th, 2013.

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Drug patent expirations by year for ROZEREM
Drug Prices for ROZEREM

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Recent Clinical Trials for ROZEREM

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Brigham and Women's HospitalPhase 4
Rhode Island HospitalPhase 4
State University of New York at BuffaloPhase 4

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Pharmacology for ROZEREM
Anatomical Therapeutic Chemical (ATC) Classes for ROZEREM
Paragraph IV (Patent) Challenges for ROZEREM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ROZEREM Tablets ramelteon 8 mg 021782 2 2009-07-22

US Patents and Regulatory Information for ROZEREM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ROZEREM ramelteon TABLET;ORAL 021782-001 Jul 22, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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