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Generated: June 20, 2018

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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 ramelteon freedom to operate?

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

Ramelteon has thirty-four patent family members in nineteen countries.

There are two drug master file entries for ramelteon. Six suppliers are listed for this compound.
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
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 (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
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 ramelteon

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
Dr Reddys Labs Sa RAMELTEON ramelteon TABLET;ORAL 091693-001 Jul 26, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Labs Fl Inc RAMELTEON ramelteon TABLET;ORAL 091610-001 Aug 19, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Non-Orange Book US Patents for ramelteon

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,218,429 Tricyclic compounds, their production and use ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Argus Health
Queensland Health
UBS
US Department of Justice
Federal Trade Commission
AstraZeneca
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.