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Serving leading biopharmaceutical companies globally:

US Army
Healthtrust
Covington
Queensland Health
McKesson
Novartis
Fuji
US Department of Justice
Johnson and Johnson
AstraZeneca

Generated: October 16, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,165,513

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Which drugs does patent 6,165,513 protect, and when does it expire?


Patent 6,165,513 protects ACTONEL WITH CALCIUM (COPACKAGED) and ACTONEL and is included in two NDAs. There have been three Paragraph IV challenges on Actonel.

Protection for ACTONEL WITH CALCIUM (COPACKAGED) has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in twenty-nine countries.

Summary for Patent: 6,165,513

Title: Film-coated tablet for improved upper gastrointestinal tract safety
Abstract:A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.
Inventor(s): Dansereau; Richard John (Mason, OH), Bekker; Petrus Jakobus (Cincinnati, OH)
Assignee: The Procter & Gamble Co. (Cincinnati, OH)
Application Number:09/095,322
Patent Claim Types:
see list of patent claims
Dosage form; Delivery; Composition;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 2000ABRXYesNo► Subscribe► SubscribeY
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 1998ABRXYesNo► Subscribe► SubscribeY
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002ABRXYesYes► Subscribe► SubscribeY
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 2007DISCNYesNo► Subscribe► SubscribeY
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008ABRXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,165,513

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
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► 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 Patent: 6,165,513

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina027158► Subscribe
Austria277606► Subscribe
Australia729912► Subscribe
Australia7446098► Subscribe
Brazil9810027► Subscribe
Canada2293815► Subscribe
China1274279► Subscribe
Colombia4940409► Subscribe
Germany69826660► Subscribe
Denmark0989848► 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:

Fish and Richardson
Merck
Dow
Fuji
Accenture
Cipla
Chinese Patent Office
US Department of Justice
Federal Trade Commission
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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