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Last Updated: March 28, 2024

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 Organon Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

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

Pharmacology for ALENDRONATE SODIUM; CHOLECALCIFEROL
Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM; CHOLECALCIFEROL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOSAMAX PLUS D Tablets alendronate sodium; cholecalciferol 70 mg/2800 IU and 70 mg/5600 IU 021762 1 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
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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