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 freedom to operate?

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

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	ALENDRONATE SODIUM; CHOLECALCIFEROL at DailyMed

Recent Clinical Trials for ALENDRONATE SODIUM; CHOLECALCIFEROL

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

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	Phase 2

See all ALENDRONATE SODIUM; CHOLECALCIFEROL clinical trials

Pharmacology for ALENDRONATE SODIUM; CHOLECALCIFEROL

Drug Class	Bisphosphonate Vitamin D

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	⤷ Sign Up	⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	⤷ Sign Up	⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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