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Serving leading biopharmaceutical companies globally:

Merck
Deloitte
McKinsey
UBS
QuintilesIMS
Mallinckrodt
Cerilliant
AstraZeneca
Citi
Chubb

Generated: October 20, 2017

DrugPatentWatch Database Preview

Alendronate sodium; cholecalciferol - Generic Drug Details

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What are the generic drug sources for alendronate sodium; cholecalciferol and what is the scope of alendronate sodium; cholecalciferol patent protection?

Alendronate sodium; cholecalciferol
is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium; cholecalciferol has ninety-one patent family members in forty countries and nine supplementary protection certificates in five countries.

There are twenty-five drug master file entries for alendronate sodium; cholecalciferol. Two suppliers are listed for this compound.

Summary for Generic Name: alendronate sodium; cholecalciferol

US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list25
Suppliers / Packagers: see list2
Clinical Trials: see list2,667
Drug Prices:see low prices
DailyMed Link:alendronate sodium; cholecalciferol at DailyMed

Pharmacology for Ingredient: alendronate sodium; cholecalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005RXYesNo► Subscribe► SubscribeY► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: alendronate sodium; cholecalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: alendronate sodium; cholecalciferol

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
6,465,443 Method for inhibiting bone resorption► Subscribe
6,015,801 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
6,432,932 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
6,225,294 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 Ingredient: alendronate sodium; cholecalciferol

Country Document Number Estimated Expiration
Ukraine67748► Subscribe
Malaysia118194► Subscribe
Chile2004000690► Subscribe
Australia8493698► Subscribe
Bulgaria66282► Subscribe
Iceland7230► Subscribe
Yugoslavia1800► Subscribe
Spain2269014► Subscribe
Singapore109478► Subscribe
Australia2007211965► 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: ALENDRONATE SODIUM; CHOLECALCIFEROL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
364Luxembourg► Subscribe91364, EXPIRES: 20200826
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
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
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
222Luxembourg► Subscribe91222, EXPIRES: 20200824
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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
2007 00045Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Fuji
Mallinckrodt
Medtronic
Chinese Patent Office
Farmers Insurance
Argus Health
Cipla
Deloitte

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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