HECTOROL Drug Patent Profile

Which patents cover Hectorol, and what generic alternatives are available?

Hectorol is a drug marketed by Sanofi and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hectorol

A generic version of HECTOROL was approved as doxercalciferol by HIKMA on August 30^th, 2013.

Summary for HECTOROL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	11
Patent Applications:	1,398
Drug Prices:	Drug price information for HECTOROL
What excipients (inactive ingredients) are in HECTOROL?	HECTOROL excipients list
DailyMed Link:	HECTOROL at DailyMed

See drug prices for HECTOROL

See drug sales revenues for HECTOROL

Recent Clinical Trials for HECTOROL

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

Sponsor	Phase
Sanofi	Phase 3
Mariana Markell	Phase 4
OPKO IP Holdings II, Inc.	Phase 1

See all HECTOROL clinical trials

Pharmacology for HECTOROL

Drug Class

Vitamin D2 Analog

Paragraph IV (Patent) Challenges for HECTOROL

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 HECTOROL

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	020862-002	Apr 23, 2004	AB	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	AP	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	AB	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	AB	RX	Yes	Yes
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	AP	RX	Yes	Yes

Expired US Patents for HECTOROL

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

International Patents for HECTOROL

See the table below for patents covering HECTOROL around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0503035	NOUVELLE 1ALPHA-HYDROXY VITAMINE D 4 ET NOUVEAUX INTERMEDIAIRES ET ANALOGUES (NOVEL 1ALPHA-HYDROXY VITAMIN D4 AND NOVEL INTERMEDIATES AND ANALOGUES)
Germany	69737066
Argentina	247817	PROCEDIMIENTO PARA PREPARAR 1-2-HIDROXI-VITAMINA D4 Y COMPUESTOS PARA SER USADOS COMO INTERMEDIARIOS EXCLUSIVAMENTE EN EL PROCEDIMIENTO (NOVEL 1-G(A)-HYDROXY VITAMIN D 4? AND NOVEL INTERMEDIATES AND ANALOGUES)
South Africa	9107553
Mexico	9707535	USO DE DERIVADOS DE VITAMINA D2 O DE VITAMINA D4 EN LA PREPARACION DE UN FARMACO PARA EL TRATAMIENTO DE HIPERPARATIROIDISMO SECUNDARIO. (USE OF VITAMIN D2 OR VITAMIN D4-DERIVATIVES FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM.)
Australia	3656193