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Last Updated: November 22, 2024

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, Andas 5 Holding, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Upsher Smith Labs, Xiromed, Zydus Pharms, and Takeda Pharms Usa, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ramelteon. Twenty-four suppliers are listed for this compound.

Summary for RAMELTEON
Drug Prices for RAMELTEON

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Recent Clinical Trials for RAMELTEON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The University of Hong KongPhase 3
University of Sao PauloPhase 4
Centennial Medical CenterPhase 4

See all RAMELTEON clinical trials

Pharmacology for RAMELTEON
Anatomical Therapeutic Chemical (ATC) Classes for RAMELTEON
Paragraph IV (Patent) Challenges for RAMELTEON
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ROZEREM Tablets ramelteon 8 mg 021782 2 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
Takeda Pharms Usa ROZEREM ramelteon TABLET;ORAL 021782-001 Jul 22, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa RAMELTEON ramelteon TABLET;ORAL 091693-001 Jul 26, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xiromed RAMELTEON ramelteon TABLET;ORAL 216209-001 Nov 25, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
I3 Pharms RAMELTEON ramelteon TABLET;ORAL 212650-001 Apr 10, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Andas 5 Holding RAMELTEON ramelteon TABLET;ORAL 215435-001 Aug 24, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms RAMELTEON ramelteon TABLET;ORAL 211567-001 Jul 22, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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