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Generated: September 24, 2017

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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, Takeda Pharms Usa, and Dr Reddys Labs Intl, 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-three patent family members in nineteen countries.

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

Summary for Generic Name: ramelteon

Tradenames:2
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list2
Suppliers / Packagers: see list5
Bulk Api Vendors: see list64
Clinical Trials: see list67
Patent Applications: see list1,341
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ramelteon at DailyMed

Pharmacology for Ingredient: 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;ORAL021782-001Jul 22, 2005ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Dr Reddys Labs Intl
RAMELTEON
ramelteon
TABLET;ORAL091693-001Jul 26, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
RAMELTEON
ramelteon
TABLET;ORAL091610-001Aug 19, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ramelteon

Country Document Number Estimated Expiration
Canada2241666► Subscribe
China1900067► Subscribe
Taiwan562803► Subscribe
China100443480► Subscribe
China1727339► Subscribe
Hong Kong1087112► Subscribe
China1212691► Subscribe
New Zealand330656► Subscribe
Japan2884153► Subscribe
JapanH10287665► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Novartis
Deloitte
Accenture
Boehringer Ingelheim
Teva
Cipla
US Department of Justice
Medtronic
QuintilesIMS
Chinese Patent Office

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.

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