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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

Tradenames:2
Patents:1
Applicants:5
NDAs:7
Drug Master File Entries: see list9
Suppliers / Packaging: see list13
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: doxercalciferol

Ingredient-typeErgocalciferols
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 ClinicalTrials.org
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
DOXERCALCIFEROL
doxercalciferol
INJECTABLE;INJECTION091333-001May 5, 2014RXNo<disabled><disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-002Apr 23, 2004RXNo6,903,083<disabled>YYY <disabled>
Roxane
DOXERCALCIFEROL
doxercalciferol
CAPSULE;ORAL091433-003Jan 14, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: doxercalciferol

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-002Apr 23, 20045,602,116<disabled>
Genzyme Corp
HECTOROL
doxercalciferol
INJECTABLE;INJECTION021027-002Apr 6, 20005,602,116<disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-001Jun 9, 19995,869,473<disabled>
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International Patent Family for Ingredient: doxercalciferol

Country Document Number Publication Date
Australia2001278956Apr 05, 2007
Japan2004504295Feb 12, 2004
Israel153378Jul 06, 2003
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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