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ATELVIA Drug Profile

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Which patents cover Atelvia, and what substitute generic drugs are available?

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-two 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. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the risedronate sodium profile page.

Summary for Tradename: ATELVIA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list50
Patent Applications: see list1,319
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ATELVIA at DailyMed

Pharmacology for Tradename: ATELVIA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYesYes7,645,459► SubscribeY ► Subscribe
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYesYes7,645,460► SubscribeY ► Subscribe
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYesYes8,246,989► SubscribeY ► Subscribe
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Expired Patents for Tradename: ATELVIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,583,122*PED► Subscribe
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,622,721► Subscribe
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Paragraph IV activity 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
8,409,615Low dosage forms of risedronate or its salts► Subscribe
8,535,718Dosage forms of bisphosphonates► 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
San MarinoAP200600038► Subscribe
CroatiaP20100583► Subscribe
Japan2011529901► Subscribe
Cyprus1111259► Subscribe
China101166519► 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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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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