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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Novartis
Moodys
AstraZeneca
Express Scripts
Deloitte
Johnson and Johnson
Teva
Harvard Business School
US Department of Justice

Generated: June 28, 2017

DrugPatentWatch Database Preview

ROZEREM Drug Profile

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Which patents cover Rozerem, and when can generic versions of Rozerem launch?

Rozerem is a drug marketed by Takeda Pharms Usa and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in nineteen countries.

The generic ingredient in ROZEREM is ramelteon. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

Summary for Tradename: ROZEREM

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Bulk Api Vendors: see list65
Clinical Trials: see list22
Patent Applications: see list740
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ROZEREM at DailyMed

Pharmacology for Tradename: 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;ORAL021782-001Jul 22, 2005ABRXYesYes6,034,239► SubscribeYY ► Subscribe
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Paragraph IV activity for: ROZEREM

Drugname Dosage Strength RLD Submissiondate
ramelteonTablets8 mgRozerem7/22/2009

Non-Orange Book Patents for Tradename: ROZEREM

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 Tradename: ROZEREM

Country Document Number Estimated Expiration
China1212691► Subscribe
Denmark0885210► Subscribe
World Intellectual Property Organization (WIPO)9732871► Subscribe
Germany69713294► Subscribe
Australia2231897► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Baxter
Cerilliant
Daiichi Sankyo
Merck
Julphar
Cipla
Fuji
McKinsey
AstraZeneca

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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