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Last Updated: August 6, 2020

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Ramelteon - Generic Drug Details

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What are the generic sources for ramelteon and what is the scope of freedom to operate?

Ramelteon is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Dr Reddys Labs Sa, I3 Pharms, Zydus Pharms, and Takeda Pharms Usa, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ramelteon has twelve patent family members in seven countries.

There are three drug master file entries for ramelteon. Eight suppliers are listed for this compound.

Drug Prices for ramelteon

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Recent Clinical Trials for ramelteon

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SponsorPhase
Rhode Island HospitalPhase 4
Saint-Joseph UniversityPhase 3
Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanPhase 4

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Pharmacology for ramelteon
Paragraph IV (Patent) Challenges for RAMELTEON
Tradename Dosage Ingredient NDA Submissiondate
ROZEREM TABLET;ORAL ramelteon 021782 2009-07-22

US Patents and Regulatory Information for ramelteon

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa RAMELTEON ramelteon TABLET;ORAL 091693-001 Jul 26, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
I3 Pharms RAMELTEON ramelteon TABLET;ORAL 212650-001 Apr 10, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc RAMELTEON ramelteon TABLET;ORAL 091610-001 Aug 19, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms RAMELTEON ramelteon TABLET;ORAL 211567-001 Jul 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
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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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Johnson and Johnson
Dow
Express Scripts
McKesson

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