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Last Updated: April 4, 2020

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ROZEREM Drug 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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in nineteen countries.

The generic ingredient in ROZEREM is ramelteon. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

US ANDA 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
Rhode Island HospitalPhase 4
The VA Western New York Healthcare SystemPhase 4
State University of New York at BuffaloPhase 4

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Recent Litigation for ROZEREM

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District Court Litigation
Case NameDate
Takeda Pharmaceutical Company LTD. v. Watson Laboratories Inc. - Florida2009-12-02

See all ROZEREM litigation

Pharmacology for ROZEREM
Synonyms for ROZEREM
(-)-N-(2-(((8S)-1,6,7,8-Tetrahydro-2H-indeno(5,4-b)furan-8-yl)ethyl)propanamide
(S)-N-(2-(1,6,7,8-tetrahydro-2H-indeno-(5,4)furan-8-yl)ethyl)propionamide
(S)-N-(2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl)propionamide
(S)-N-(2-(2,6,7,8-tetrahydro-1H-indeno[5,4-b]furan-8-yl)ethyl)propionamide
(S)-N-(2-[1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl)propionamide
(S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide
(S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide
196597-26-9
597R269
901AS54I69
AB0017627
AB01274760_02
AB01274760_03
AB01274760-01
AB1008454
ABP001059
AC-5275
ACT06830
AKOS015895741
AM84670
AOB87305
API0000796
AS-15740
BDBM50118470
BRD-K28761891-001-01-0
BRD-K28761891-001-04-4
BSPBio_002318
CCG-213557
CHEBI:109549
CHEMBL1218
CR0011
CS-0382
CTK8E7499
D02689
DB00980
FT-0655799
GTPL1356
HMS1922H18
HMS2093F12
HSDB 7787
HY-A0014
J-502508
JEV
KS-00000XI5
LS-186569
LS-187367
MLS003915619
MLS006010029
N-[2-(1,6,7,8-Tetrahydro-2H-3-oxa-as-indacen-8-yl)-ethyl]-propionamide(S)-(-)-22b
N-[2-[(8S)-2,6,7,8-tetrahydro-1H-cyclopenta[e][1]benzofuran-8-yl]ethyl]propanamide
N-[2-[(8S)-2,6,7,8-tetrahydro-1H-cyclopenta[e][1]benzoxol-8-yl]ethyl]propanamide
N-[2-[(8S)-2,6,7,8-tetrahydro-1H-cyclopenta[e]benzofuran-8-yl]ethyl]propanamide
N-{2-[(8S)-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl}propanamide
N-{2-[(8S)-1H,2H,6H,7H,8H-INDENO[5,4-B]FURAN-8-YL]ETHYL}PROPANAMIDE
NCGC00178707-03
PB27872
Propanamide, N-(2-((8S)-1,6,7,8-tetrahydro-2H-indeno(5,4-b)furan-8-yl)ethyl)-
PubChem19120
Q-4378
Q417689
Q499
Ramelteon
Ramelteon (JAN/USAN/INN)
Ramelteon (TAK-375)
Ramelteon [USAN:INN:BAN:JAN]
Ramelteon [USAN]
Ramelteon 1.0 mg/ml in Acetonitrile
Ramelteon solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Ramelteon, TAK-375
Rozerem (TN)
RT-015379
s1259
SBI-0206874.P001
SCHEMBL29237
SMR002544684
SPECTRUM1505817
SR-05000001957
SR-05000001957-1
SR-05000001957-3
ST24049116
SW219712-1
TAK-375
TAK-375SL
TAK375
UNII-901AS54I69
YLXDSYKOBKBWJQ-LBPRGKRZSA-N
Z2037281108
ZINC3960338
Paragraph IV (Patent) Challenges for ROZEREM
Tradename Dosage Ingredient NDA Submissiondate
ROZEREM TABLET;ORAL ramelteon 021782 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   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa ROZEREM ramelteon TABLET;ORAL 021782-001 Jul 22, 2005 AB RX Yes Yes   Start Trial   Start Trial Y 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:

Merck
Dow
Harvard Business School
Express Scripts
Moodys
Baxter

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