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Serving leading biopharmaceutical companies globally:

Cipla
AstraZeneca
McKesson
Baxter
Moodys
Johnson and Johnson
Harvard Business School
Mallinckrodt
McKinsey
Cerilliant

Generated: December 11, 2017

DrugPatentWatch Database Preview

ATELVIA Drug Profile

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

Atelvia is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-six patent family members in thirty-one countries.

The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Drug patent expirations by year for ATELVIA

Pharmacology for ATELVIA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Medical Subject Heading (MeSH) Categories for ATELVIA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
ApilATELVIArisedronate sodiumTABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilATELVIArisedronate sodiumTABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilATELVIArisedronate sodiumTABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for ATELVIA

Drugname Dosage Strength RLD Submissiondate
risedronate sodiumDelayed-release Tablets35 mgAtelvia7/19/2011

Non-Orange Book Patents for Tradename: ATELVIA

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
8,409,614Low dosage forms of risedronate or its salts► Subscribe
8,535,718Dosage forms of bisphosphonates► Subscribe
8,409,615Low dosage forms of risedronate or its salts► 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: ATELVIA

Country Document Number Estimated Expiration
China1956706► Subscribe
Japan2008500339► Subscribe
Russian Federation2381791► Subscribe
Hong Kong1161130► Subscribe
World Intellectual Property Organization (WIPO)2010014765► Subscribe
South Korea20110002887► Subscribe
San MarinoP200700047► Subscribe
China102225047► Subscribe
World Intellectual Property Organization (WIPO)2005115331► Subscribe
European Patent Office1868584► 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 leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
Citi
Dow
US Department of Justice
Covington
US Army
Harvard Business School
Queensland Health
Chubb

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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