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Profile for Tradename: HECTOROL

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Hectorol is a drug marketed by Genzyme Corp and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and four Paragraph IV challenges.

This drug has eight patent family members in six countries.

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

Summary for Tradename: HECTOROL

Suppliers / Packagers: see list13

Pharmacology for Tradename: HECTOROL

Drug ClassVitamin D2 Analog

Clinical Trials for: HECTOROL

A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Status: Completed Condition: Secondary Hyperparathyroidism

Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Status: Completed Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure

Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Status: Recruiting Condition: Chronic Kidney Disease; Kidney Transplantation

A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Status: Completed Condition: Chronic Kidney Disease, Stage 5; Secondary Hyperparathyroidism

A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
Status: Completed Condition: Moderate to Severe Chronic Plaque Psoriasis

A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Status: Completed Condition: Secondary Hyperparathyroidism

A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Status: Completed Condition: Secondary Hyperparathyroidism

Doxercalciferol in Recurrent Pediatric Solid Tumors
Status: Terminated Condition: Solid Tumors

Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients
Status: Terminated Condition: Hyperparathyroidism, Secondary

Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Stage Three and Four
Status: Completed Condition: Secondary Hyperparathyroidism in Chronic Kidney Disease Stage 3 and 4

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp
CAPSULE;ORAL020862-002Apr 23, 2004RXNo6,903,083<disabled>YYY <disabled>
Genzyme Corp
INJECTABLE;INJECTION021027-002Apr 6, 2000RXNo<disabled><disabled>
Genzyme Corp
CAPSULE;ORAL020862-003Jul 13, 2009RXNo<disabled><disabled>
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Paragraph IV activity for: HECTOROL

Drugname Dosage Strength RLD Submissiondate
doxercalciferolInjection2 mcg/mL, 1 mL in 2 mL vialHectorol12/28/2011
doxercalciferolCapsules1 mcgHectorol2/12/2010
doxercalciferolCapsules0.5 mcg and 2.5 mcgHectorol3/25/2009
doxercalciferolInjection2 mcg/mL, 2 mL ampulesHectorol10/15/2007

International Patent Family for Tradename: HECTOROL

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)0206218Jul 18, 2002
Israel153378Jul 06, 2003
Japan2004504295Feb 12, 2004
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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