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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020862

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NDA 020862 describes HECTOROL, which is a drug marketed by Sanofi and is included in two NDAs. Additional details are available on the HECTOROL profile page.

The generic ingredient in HECTOROL is doxercalciferol. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

Summary for 020862

Tradename:	HECTOROL
Applicant:	Sanofi
Ingredient:	doxercalciferol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	2.5MCG
Approval Date:	Jun 9, 1999	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 11, 2028
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Apr 23, 2004	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 11, 2028
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	1MCG
Approval Date:	Jul 13, 2009	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 11, 2028
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Expired US Patents for NDA 020862

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,861,386	⤷ Get Started Free
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	5,602,116	⤷ Get Started Free
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,869,473	⤷ Get Started Free
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	6,903,083	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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