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Last Updated: August 8, 2020

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ROZEREM Drug 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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in seven countries.

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

US ANDA 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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SponsorPhase
Rhode Island HospitalPhase 4
State University of New York at BuffaloPhase 4
The VA Western New York Healthcare SystemPhase 4

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Pharmacology for ROZEREM
Paragraph IV (Patent) Challenges for ROZEREM
Tradename Dosage Ingredient NDA Submissiondate
ROZEREM TABLET;ORAL ramelteon 021782 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   Start Trial   Start Trial Y   Start 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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