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Generated: October 18, 2017

DrugPatentWatch Database Preview

Calcitriol - Generic Drug Details

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What are the generic sources for calcitriol and what is the scope of calcitriol patent protection?

Calcitriol
is the generic ingredient in four branded drugs marketed by Sagent Pharms, Rockwell Medcl, Hospira, West-ward Pharms Int, Teva Parenteral, Fresenius Kabi Usa, Validus Pharms, Luitpold, Strides Pharma, Teva, Akorn, Fresenius Medcl, Bionpharma Inc, Abbvie, Galderma Labs Lp, and Amneal Pharms, and is included in eighteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for calcitriol. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: calcitriol

US Patents:3
Tradenames:4
Applicants:16
NDAs:18
Drug Master File Entries: see list10
Suppliers / Packagers: see list23
Bulk Api Vendors: see list60
Clinical Trials: see list139
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:calcitriol at DailyMed

Pharmacology for Ingredient: calcitriol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Tentative approvals for CALCITRIOL

Applicant Application No. Strength Dosage Form
u► Subscribe0.001MG/MLINJECTABLE;INJECTION
u► Subscribe0.002MG/MLINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int
CALCITRIOL
calcitriol
SOLUTION;ORAL076242-001Jul 18, 2003AARXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
CALCITRIOL
calcitriol
INJECTABLE;INJECTION075836-001Dec 31, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
VECTICAL
calcitriol
OINTMENT;TOPICAL022087-001Jan 23, 2009RXYesYes► Subscribe► Subscribe► Subscribe
Strides Pharma
CALCITRIOL
calcitriol
CAPSULE;ORAL091356-001Dec 12, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
CALCITRIOL
calcitriol
CAPSULE;ORAL075765-001Oct 12, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
Akorn
CALCITRIOL
calcitriol
INJECTABLE;INJECTION078066-002Jan 29, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-001Sep 25, 1986DISCNYesNo► Subscribe► SubscribeY► Subscribe
Rockwell Medcl
CALCITRIOL
calcitriol
INJECTABLE;INJECTION076206-001Sep 17, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Akorn
CALCITRIOL
calcitriol
INJECTABLE;INJECTION078066-001Jan 29, 2008RXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Medcl
CALCITRIOL
calcitriol
INJECTABLE;INJECTION075766-002Feb 20, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: calcitriol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-002Sep 25, 1986► Subscribe► Subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-001Sep 25, 1986► Subscribe► Subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Abbvie
CALCIJEX
calcitriol
INJECTABLE;INJECTION018874-002Sep 25, 1986► Subscribe► Subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Deloitte
McKinsey
Cantor Fitzgerald
Johnson and Johnson
Accenture
UBS
Federal Trade Commission
Baxter
Chubb
US Army

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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