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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Boehringer Ingelheim
Cantor Fitzgerald
Novartis
Mallinckrodt
Colorcon
QuintilesIMS
Baxter
Fuji

Generated: December 16, 2017

DrugPatentWatch Database Preview

ACTONEL WITH CALCIUM (COPACKAGED) Drug Profile

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Which patents cover Actonel With Calcium (copackaged), and when can generic versions of Actonel With Calcium (copackaged) launch?

Actonel With Calcium (copackaged) is a drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and twenty-six patent family members in forty-four countries and seventeen supplementary protection certificates in seven countries.

The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) is calcium carbonate; risedronate sodium. There are two hundred and seventy drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for ACTONEL WITH CALCIUM (COPACKAGED)

Drug patent expirations by year for ACTONEL WITH CALCIUM (COPACKAGED)

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005► Subscribe► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

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
6,225,294 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
6,333,316 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 Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

Country Document Number Estimated Expiration
Australia6406900► Subscribe
Taiwan200300092► Subscribe
Australia741818► Subscribe
Australia2451102► Subscribe
Spain2164447► Subscribe
Eurasian Patent Organization200000151► Subscribe
Colombia4940409► Subscribe
Australia2007211965► Subscribe
Netherlands300292► Subscribe
Netherlands300223► 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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Supplementary Protection Certificates for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
364Luxembourg► Subscribe91364, EXPIRES: 20200826
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2007 00045Denmark► Subscribe
2007007Lithuania► SubscribePRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
00292Netherlands► SubscribePRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
2006002,C0998292Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
2006 00005Denmark► Subscribe
2014 00050Denmark► SubscribePRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
2006002Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
/2008Austria► SubscribePRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Citi
Dow
Fuji
US Department of Justice
Colorcon
Julphar
McKesson
Moodys

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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