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Calcium carbonate; risedronate sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for calcium carbonate; risedronate sodium?

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 nineteen patent family members in forty-four countries.

There are two hundred and fifty-nine drug master file entries for calcium carbonate; risedronate sodium.

Summary for Generic Name: calcium carbonate; risedronate sodium

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list259
Clinical Trials: see list1,621
Drug Prices:see low prices
DailyMed Link:calcium carbonate; risedronate sodium at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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;ORAL021823-001Aug 12, 2005DISCNYesNo6,015,801*PED► SubscribeY► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo6,465,443*PED► SubscribeY► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo5,994,329*PED► SubscribeY► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo6,165,513*PED► SubscribeY► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo6,432,932*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: 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;ORAL021823-001Aug 12, 20055,583,122*PED► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20056,096,342*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
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 Ingredient: calcium carbonate; risedronate sodium

Country Document Number Estimated Expiration
South Korea20030097610► Subscribe
Uruguay25950► Subscribe
Singapore108292► Subscribe
China1602880► Subscribe
Indonesia24096► 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: CALCIUM CARBONATE; RISEDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2008006Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2006 00005Denmark► Subscribe
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
/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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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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