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Last Updated: October 1, 2022

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. Thirteen 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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SponsorPhase
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ROZEREM

See the table below for patents covering ROZEREM around the world.

Country Patent Number Title Estimated Expiration
Australia 1430502 See Plans and Pricing
Germany 60142305 See Plans and Pricing
European Patent Office 2305219 See Plans and Pricing
Norway 322205 See Plans and Pricing
Japan 2002212063 COPOLYVIDONE-CONTAINING PHARMACEUTICAL PREPARATION See Plans and Pricing
Germany 69713294 See Plans and Pricing
China 1727339 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Baxter

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