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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Medtronic
Covington
Accenture
Cantor Fitzgerald
Healthtrust
Daiichi Sankyo
Chubb
QuintilesIMS
Argus Health

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,465,443

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Which drugs does patent 6,465,443 protect, and when does it expire?


Patent 6,465,443 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 eighty-six patent family members in forty countries.

Summary for Patent: 6,465,443

Title: Method for inhibiting bone resorption
Abstract:Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
Inventor(s): Daifotis; Anastasia G. (Westfield, NJ), Santora, II; Arthur C. (Watchung, NJ), Yates; A. John (Westfield, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:09/812,450
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Device;

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, 2005DISCNYesNo6,465,443*PED► SubscribeY
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002ABRXYesYes6,465,443*PED► SubscribeY
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Non-Orange Book Patents for Patent: 6,465,443

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
6,333,316 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
5,994,329 Method for inhibiting bone resorption► Subscribe
6,225,294 Method for inhibiting bone resorption► Subscribe
6,432,932 Method for inhibiting bone resorption► 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: 6,465,443

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria209037► Subscribe
Austria357921► Subscribe
Australia2005227418► Subscribe
Australia2007211965► Subscribe
Australia2451102► 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 500+ biopharmaceutical companies globally:

Chubb
Julphar
QuintilesIMS
Teva
Chinese Patent Office
Healthtrust
US Department of Justice
Colorcon
Merck
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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