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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Teva
Baxter
Julphar
McKesson
Covington
UBS
McKinsey
QuintilesIMS

Generated: August 17, 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-seven 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
6,333,316 Method for inhibiting bone resorption ➤ Try a Free Trial
6,544,967 Method for inhibiting bone resorption ➤ Try a Free Trial
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety ➤ Try a Free Trial
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
1175904/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
2014000088 Germany ➤ Try a Free Trial PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
2007007 Lithuania ➤ Try a Free Trial 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
0689 Netherlands ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Argus Health
Queensland Health
Accenture
Fish and Richardson
US Army
Dow
McKesson

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