Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: doxercalciferol

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

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: see list3
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
CAPSULE;ORAL091433-002Jan 14, 2014RXNo<disabled><disabled>
Genzyme Corp
CAPSULE;ORAL020862-003Jul 13, 2009RXNo<disabled><disabled>
CAPSULE;ORAL091433-001Sep 23, 2011RXNo<disabled><disabled>
INJECTABLE;INJECTION200926-001Feb 4, 2014RXNo<disabled><disabled>
Genzyme Corp
INJECTABLE;INJECTION021027-002Apr 6, 2000RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a free trial or see the plan comparison

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 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn