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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Citi
Chubb
AstraZeneca
QuintilesIMS
Chinese Patent Office
Farmers Insurance
Merck
Queensland Health

Generated: June 21, 2018

DrugPatentWatch Database Preview

Calcium carbonate; risedronate sodium - Generic Drug Details

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What are the generic drug sources for calcium carbonate; risedronate sodium and what is the scope of calcium carbonate; risedronate sodium freedom to operate?

Calcium carbonate; risedronate sodium
is the generic ingredient in one branded drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcium carbonate; risedronate sodium has one hundred and twenty-seven patent family members in forty-four countries.

There are two hundred and seventy-five drug master file entries for calcium carbonate; risedronate sodium.
Summary for calcium carbonate; risedronate sodium

US Patents and Regulatory Information for calcium carbonate; risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for calcium carbonate; risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 ➤ Sign Up ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for calcium carbonate; risedronate sodium

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
6,225,294 Method for inhibiting bone resorption ➤ Sign Up
6,333,316 Method for inhibiting bone resorption ➤ Sign Up
6,544,967 Method for inhibiting bone resorption ➤ Sign Up
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for calcium carbonate; risedronate sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007007 Lithuania ➤ Sign Up PRODUCT 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
2007 00045 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
2018 00006 Denmark ➤ Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
/2008 Austria ➤ Sign Up PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Fish and Richardson
Medtronic
Moodys
Chubb
Cipla
AstraZeneca
Cerilliant

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.