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Generated: December 13, 2018

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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. Four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

Drug patent expirations by year for ROZEREM
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
AC1L4LKM
AC1Q5OQL
ACT06830
AJ-47537
AK117788
AKOS015895741
AM84670
AN-3478
AOB87305
API0000796
AS-15740
BC225579
BDBM50118470
BRD-K28761891-001-01-0
BSPBio_002318
CCG-213557
CHEBI:109549
CHEMBL1218
CR0011
CS-0382
CTK8E7499
D02689
D0U0KW
DB00980
FT-0655799
GTPL1356
HMS1922H18
HMS2093F12
HY-A0014
I06-1429
J-502508
KS-00000XI5
LS-186569
LS-187367
MFCD08067736
MLS003915619
MLS006010029
MolPort-003-666-751
N-[-[(8S)-1,6,7,8-TETRAHYDRO-2H-INDENO[5,4-B]FURAN-8-YL]ETHYL]PROPANAMIDE
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]fur-8-yl]ethyl}propanamid
N-{2-[(8S)-1H,2H,6H,7H,8H-INDENO[5,4-B]FURAN-8-YL]ETHYL}PROPANAMIDE
NCGC00178707-03
PB27872
PL004518
PL049624
Propanamide, N-(2-((8S)-1,6,7,8-tetrahydro-2H-indeno(5,4-b)furan-8-yl)ethyl)-
PubChem19120
Q-4378
Q499
Ramelteon
Ramelteon (JAN/USAN/INN)
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
RL02472
Rozerem (TN)
Rozerem, TAK-375, Ramelteon
RT-015379
s1259
SBI-0206874.P001
SCHEMBL29237
SMR002544684
SPECTRUM1505817
SR-05000001957
SR-05000001957-3
ST24049116
TAK-375
TAK-375SL
TAK375
UNII-901AS54I69
YLXDSYKOBKBWJQ-LBPRGKRZSA-N
Z2037281108
ZINC3960338

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Takeda Pharms Usa ROZEREM ramelteon TABLET;ORAL 021782-001 Jul 22, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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Paragraph IV (Patent) Challenges for ROZEREM
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 8 mg ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
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Cerilliant
US Department of Justice
US Army
Citi
Covington
Teva
Mallinckrodt

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