Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

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RAMELTEON - Generic Drug Details

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What are the generic drug sources for ramelteon and what is the scope of patent protection?

Ramelteon is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Dr Reddys Labs Sa, Zydus Pharms, and Takeda Pharms Usa, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ramelteon has forty-six patent family members in nineteen countries.

There are three drug master file entries for ramelteon. Five suppliers are listed for this compound.

Drug Prices for RAMELTEON

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Recent Clinical Trials for RAMELTEON

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SponsorPhase
Rhode Island HospitalPhase 4
Saint-Joseph UniversityPhase 3
Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanPhase 4

See all RAMELTEON clinical trials

Recent Litigation for RAMELTEON

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

See all RAMELTEON litigation

Pharmacology for RAMELTEON
Synonyms for RAMELTEON
(-)-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
AKOS015895741
AM84670
AN-3478
AOB87305
API0000796
AS-15740
BC225579
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
I06-1429
J-502508
KS-00000XI5
LS-186569
LS-187367
MLS003915619
MLS006010029
MolPort-003-666-751
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
Propanamide, N-(2-((8S)-1,6,7,8-tetrahydro-2H-indeno(5,4-b)furan-8-yl)ethyl)-
PubChem19120
Q-4378
Q499
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
RL02472
Rozerem
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 RAMELTEON
Tradename Dosage Ingredient NDA Submissiondate
ROZEREM TABLET;ORAL ramelteon 021782 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
Actavis Labs Fl Inc RAMELTEON ramelteon TABLET;ORAL 091610-001 Aug 19, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa ROZEREM ramelteon TABLET;ORAL 021782-001 Jul 22, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Zydus Pharms RAMELTEON ramelteon TABLET;ORAL 211567-001 Jul 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Sa RAMELTEON ramelteon TABLET;ORAL 091693-001 Jul 26, 2013 AB RX No No   Start Trial   Start Trial   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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