Is there a generic for Ramelteon?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Ramelteon, referencing the brand ROZEREM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ramelteon?

ROZEREM (NDA 021782, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ramelteon are approved?

Ramelteon is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ramelteon

Ramelteon: 1 brand, 11 generics; first approved Jul 22, 2005; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 11 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

ROZEREMRLDRS

TAKEDA PHARMS USANDA 0217822005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (11)

RAMELTEON

HIBROW HLTHCAREANDA 2154852026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

AUROBINDO PHARMA LTDANDA 2159722023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

MICRO LABSANDA 2152432023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

XIROMEDANDA 2162092022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

ANDAS 5 HOLDINGANDA 2154352022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

APPCOANDA 2138152020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

GRANULESANDA 2131862020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Discontinued	—

RAMELTEON

I3 PHARMSANDA 2126502020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

ZYDUS PHARMSANDA 2115672019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

ACTAVIS LABS FL INCANDA 0916102015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

RAMELTEON

DR REDDYS LABS SAANDA 0916932013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG	TABLET	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jul 22, 2005

21 yr 3 mo ago

Most recent approval

Jun 04, 2026

1 mo ago

Approvals span 2005–2026 across 12 FDA applications.

Brand (NDA) 18%

Generic (ANDA) 1192%

Ramelteon — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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