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Serving leading biopharmaceutical companies globally:

Citi
Covington
Mallinckrodt
Boehringer Ingelheim
Chubb
Cipla
Cerilliant
McKesson
Argus Health
US Army

Generated: February 18, 2018

DrugPatentWatch Database Preview

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 Intl, 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

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Intl 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
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
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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International Patents for ramelteon

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Harvard Business School
Covington
Mallinckrodt
Cipla
Chinese Patent Office
Moodys
Cerilliant
Queensland Health

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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