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Last Updated: January 23, 2020

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Alendronate sodium; cholecalciferol - Generic Drug Details

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What are the generic sources for alendronate sodium; cholecalciferol and what is the scope of 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.

There are twenty-five drug master file entries for alendronate sodium; cholecalciferol. One supplier is listed for this compound.

Summary for alendronate sodium; cholecalciferol
Recent Clinical Trials for alendronate sodium; cholecalciferol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 2

See all alendronate sodium; cholecalciferol clinical trials

Recent Litigation for alendronate sodium; cholecalciferol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Warner Chilcott Company v. Teva Pharmaceuticals USA Inc.2008-09-26
Procter & Gamble Company v. Teva Pharmaceuticals USA Inc.2008-02-01
AstraZeneca Pharmaceuticals LP v. Apotex Inc.2007-12-11

See all alendronate sodium; cholecalciferol litigation

Pharmacology for alendronate sodium; cholecalciferol
Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM; CHOLECALCIFEROL
Tradename Dosage Ingredient NDA Submissiondate
FOSAMAX PLUS D TABLET;ORAL alendronate sodium; cholecalciferol 021762 2007-11-20

US Patents and Regulatory Information for 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;ORAL 021762-002 Apr 26, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for alendronate sodium; cholecalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005   Start Trial   Start Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007   Start Trial   Start Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for alendronate sodium; cholecalciferol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0998292 PA2006002,C0998292 Lithuania   Start Trial PRODUCT 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
0998292 PA2006002 Lithuania   Start Trial PRODUCT 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
1175904 CA 2007 00045 Denmark   Start Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
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Merck
Express Scripts
Medtronic
Harvard Business School

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