Viewing data from:

ROZEREM

NDA

RAMELTEON | N021782 | TAKEDA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

60 trials from ClinicalTrials.gov, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)NCT01048242	Phase 3	Completed	University of Pennsylvania	27	2006-07 → 2009-03
Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease NCT00316992	Phase 4	Completed	Takeda	25	2006-04 → 2006-11
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia NCT00507546	Phase 4	Completed	US Department of Veterans Affairs	12	2007-07 → 2011-07
Differential Effects of Zolpidem Versus Ramelteon in Burned Children NCT00539110	Phase 2	Completed	Shriners Hospitals for Children	10	2009-12 → 2013-11
Effect of Ramelteon on Smoking Abstinence NCT02560324	Phase 2	Completed	University of Pennsylvania	140	2015-09 → 2018-08
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder NCT01401413	Phase 4	Completed	Sleep Medicine Centers of WNY	20	2008-01 → 2010-09
Efficacy and Safety of Ramelteon on Chronic Insomnia NCT00915135	Phase 2	Completed	Takeda	66	2002-05 → 2003-12
Ramelteon for Treatment of Insomnia in Cirrhosis NCT03091738	Phase 4	Completed	Virginia Commonwealth University	10	2017-02-01 → 2018-10-01
Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea NCT00672061	Phase 2	Completed	Takeda	26	2003-07 → 2003-12
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia NCT00671255	Phase 3	Completed	Takeda	829	2002-12 → 2004-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$12.41

per ea

Lowest NADAC/Unit

$12.41

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64764080510ROZEREM 8 MG TABLET	$12.41	EA	Brand	$0.6660	2026-10-21
64764080530ROZEREM 8 MG TABLET	$12.41	EA	Brand	$0.6660	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$283.80

Highest Price

$949.86

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64764-0805-10ROZEREM 8MG TAB	$949.86	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
64764-0805-30ROZEREM 8MG TAB	$283.80	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Rozerem (2024)

Total Spending

$735K

Total Claims

1,774

Beneficiaries

504

Avg Cost/Unit

$11.48

Spending Trend

$37.6M(2019)→$3.8M(2020)→$1.8M(2021)→$1.4M(2022)→$1.0M(2023)→$735K(2024)

YoY Change:-6.6%

5yr CAGR:-0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVRAMELTEON

DMF 228822009

MSN LABORATORIES PRIVATE LTDRAMELTEON

DMF 315062017

SS PHARMA LLCRAMELTEON

DMF 324442018

ENALTEC LABS PRIVATE LTDRAMELTEON

DMF 336012019

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDRAMELTEON

DMF 337192019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRAMELTEON

DMF 344142019

APITORIA PHARMA PRIVATE LTDRAMELTEON

DMF 348992020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2021	SUPPL -22	View Letter (PDF)
Dec 30, 2018	SUPPL -21	View Letter (PDF)
Mar 5, 2012	SUPPL -14	View Letter (PDF)
Mar 5, 2012	SUPPL -6	View Letter (PDF)
Mar 5, 2012	SUPPL -12	View Letter (PDF)
Aug 5, 2011	SUPPL -15	View Letter (PDF)
Nov 15, 2010	SUPPL -11	View Letter (PDF)
Oct 23, 2008	SUPPL -10	View Letter (PDF)
Oct 23, 2008	SUPPL -8	View Letter (PDF)
Oct 23, 2008	SUPPL -9	View Letter (PDF)
Aug 23, 2005	SUPPL -1	View Letter (PDF)
Jul 26, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 22, 2005

No patent or exclusivity listings for this strength.