Deep knowledge on
small-molecule drugs and
the 100,000 global patents
covering them

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

How are People Using DrugPatentWatch?

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: paricalcitol

« Back to Dashboard
Paricalcitol is the generic ingredient in two branded drugs marketed by Amneal Pharms, Aurobindo Pharma Ltd, Banner Life Sciences, Dr Reddys Labs Ltd, Rising Pharms Inc, Teva Pharms Usa, Abbvie, Hikma Pharms, Hospira Inc, and Sandoz Canada Inc, and is included in eleven NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for paricalcitol. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: paricalcitol

Drug Master File Entries: see list10
Suppliers / Packaging: see list17
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: paricalcitol

Drug ClassVitamin D3 Analog

Tentative approvals for PARICALCITOL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION2MCG/ML
<disabled><disabled>INJECTABLE; INJECTION5MCG/ML
<disabled><disabled>INJECTABLE; INJECTION10MCG/ML

Clinical Trials for: paricalcitol

The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors
Status: Completed Condition: Diabetic Nephropathy; Chronic Kidney Disease

Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Status: Completed Condition: Secondary Hyperparathyroidism; Dialysis

The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Status: Completed Condition: Chronic Kidney Disease

Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Status: Completed Condition: Chronic Kidney Disease; Endothelial Dysfunction; Inflammation; Hypertension

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Status: Completed Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis

The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
Status: Terminated Condition: Chronic Kidney Disease (CKD) Stage 5; Hypertrophy, Left Ventricular

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
Hikma Pharms
SOLUTION;INTRAVENOUS205917-002Nov 18, 2014RXNo<disabled><disabled>
Rising Pharms Inc
CAPSULE;ORAL202124-002Jun 24, 2014RXNo<disabled><disabled>
Aurobindo Pharma Ltd
CAPSULE;ORAL207672-002Jan 14, 2016RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: paricalcitol

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
SOLUTION;INTRAVENOUS020819-003Feb 1, 20005,597,815*PED<disabled>
CAPSULE;ORAL021606-001May 26, 20055,246,925*PED<disabled>
CAPSULE;ORAL021606-003May 26, 20055,587,497*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and 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 2002-2016 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