Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Express Scripts
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McKesson
Harvard Business School

Last Updated: November 12, 2019

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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 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

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SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 2

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Recent Litigation for alendronate sodium; cholecalciferol

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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

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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 021762-002 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
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
>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
1175904 C300292 Netherlands   Start Trial PRODUCT 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
0998292 91222 Luxembourg   Start Trial 91222, EXPIRES: 20200824
1175904 91364 Luxembourg   Start Trial 91364, EXPIRES: 20200826
1175904 PA2007007 Lithuania   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Express Scripts
Mallinckrodt
Dow
Colorcon

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