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Details for Generic Name: doxercalciferol

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Doxercalciferol is the generic ingredient in two branded drugs marketed by Roxane, Genzyme Corp, Akorn Inc, Hikma Pharms Llc, and Sandoz Inc, and is included in seven NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has eight patent family members in six countries.

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

Summary for Generic Name: doxercalciferol

Drug Master File Entries: see list9
Suppliers / Packaging: see list13
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: doxercalciferol

Drug ClassVitamin D2 Analog

Tentative approvals for DOXERCALCIFEROL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION2MCG/ML

Clinical Trials for: doxercalciferol

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

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

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

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

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
Sandoz Inc
INJECTABLE;INJECTION091333-001May 5, 2014RXNo<disabled><disabled>
CAPSULE;ORAL091433-002Jan 14, 2014RXNo<disabled><disabled>
Hikma Pharms Llc
INJECTABLE;INJECTION091101-001Aug 30, 2013RXNo<disabled><disabled>
Genzyme Corp
CAPSULE;ORAL020862-003Jul 13, 2009RXNo<disabled><disabled>
Genzyme Corp
CAPSULE;ORAL020862-001Jun 9, 1999RXYes6,903,083<disabled>YYY <disabled>
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International Patent Family for Ingredient: doxercalciferol

Country Document Number Publication Date
Australia2001278956Apr 05, 2007
Israel153378Jul 06, 2003
Japan2004504295Feb 12, 2004
European Patent Office2070911Jun 17, 2009
World Intellectual Property Organization (WIPO)0206218Jul 18, 2002
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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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