DOXERCALCIFEROL - Generic Drug Details

What are the generic sources for doxercalciferol and what is the scope of freedom to operate?

Doxercalciferol is the generic ingredient in two branded drugs marketed by Avet, Hikma, Rising, Sanofi, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for doxercalciferol. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DOXERCALCIFEROL

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	18
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	18
Patent Applications:	2,528
Drug Prices:	Drug price trends for DOXERCALCIFEROL
What excipients (inactive ingredients) are in DOXERCALCIFEROL?	DOXERCALCIFEROL excipients list
DailyMed Link:	DOXERCALCIFEROL at DailyMed

See drug prices for DOXERCALCIFEROL

Recent Clinical Trials for DOXERCALCIFEROL

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

Sponsor	Phase
Sanofi	Phase 3
OPKO Health, Inc.	Phase 3
OPKO Ireland Global Holdings Ltd.	Phase 3

See all DOXERCALCIFEROL clinical trials

Generic filers with tentative approvals for DOXERCALCIFEROL

Applicant	Application No.	Strength	Dosage Form
		2MCG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DOXERCALCIFEROL

Drug Class

Vitamin D2 Analog

Anatomical Therapeutic Chemical (ATC) Classes for DOXERCALCIFEROL

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for DOXERCALCIFEROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HECTOROL	Injection	doxercalciferol	2 mcg/mL, 1 mL in 2 mL vial	021027	1	2011-12-28
HECTOROL	Capsules	doxercalciferol	1 mcg	020862	1	2010-02-12
HECTOROL	Capsules	doxercalciferol	0.5 mcg and 2.5 mcg	020862	1	2009-03-25
HECTOROL	Injection	doxercalciferol	2 mcg/mL, 2 mL ampules	021027	1	2007-10-15

US Patents and Regulatory Information for DOXERCALCIFEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	AB	RX	Yes	No
Sun Pharm	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	203875-001	Nov 14, 2019		DISCN	No	No
Sandoz	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	200926-001	Feb 4, 2014	AP	RX	No	No
Sandoz	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	091333-001	May 5, 2014	AP	RX	No	No
Epic Pharma Llc	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	203929-002	Mar 28, 2016		DISCN	No	No
Epic Pharma Llc	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	203929-001	May 7, 2015		DISCN	No	No
Hikma	DOXERCALCIFEROL	doxercalciferol	CAPSULE;ORAL	091433-001	Sep 23, 2011		DISCN	No	No

Expired US Patents for DOXERCALCIFEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999