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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Johnson and Johnson
McKesson
AstraZeneca
Baxter
Queensland Health
Julphar
Accenture
Express Scripts

Generated: December 13, 2017

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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 Amneal Pharms, Bionpharma Inc, Strides Pharma, Teva, West-ward Pharms Int, Validus Pharms, Abbvie, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, Teva Parenteral, and Galderma Labs Lp, 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-one suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for calcitriol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Medical Subject Heading (MeSH) Categories for calcitriol

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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AkornCALCITRIOLcalcitriolINJECTABLE;INJECTION078066-002Jan 29, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Rockwell MedclCALCITRIOLcalcitriolINJECTABLE;INJECTION076206-001Sep 17, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaCALCITRIOLcalcitriolCAPSULE;ORAL075765-001Oct 12, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sagent PharmsCALCITRIOLcalcitriolINJECTABLE;INJECTION077102-001Feb 8, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
West-ward Pharms IntCALCITRIOLcalcitriolSOLUTION;ORAL076242-001Jul 18, 2003AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Strides PharmaCALCITRIOLcalcitriolCAPSULE;ORAL091356-001Dec 12, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieCALCIJEXcalcitriolINJECTABLE;INJECTION018874-001Sep 25, 1986DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieCALCIJEXcalcitriolINJECTABLE;INJECTION018874-001Sep 25, 1986DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieCALCIJEXcalcitriolINJECTABLE;INJECTION018874-002Sep 25, 1986DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaCALCITRIOLcalcitriolINJECTABLE;INJECTION075836-002Dec 31, 2002DISCNNoNo► Subscribe► 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 PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
AbbvieCALCIJEXcalcitriolINJECTABLE;INJECTION018874-002Sep 25, 1986► Subscribe► Subscribe
Validus PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Validus PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
AbbvieCALCIJEXcalcitriolINJECTABLE;INJECTION018874-001Sep 25, 1986► Subscribe► Subscribe
Validus PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Validus PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
AbbvieCALCIJEXcalcitriolINJECTABLE;INJECTION018874-001Sep 25, 1986► Subscribe► Subscribe
Validus PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Validus PharmsROCALTROLcalcitriolCAPSULE;ORAL018044-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Daiichi Sankyo
Dow
McKinsey
AstraZeneca
Julphar
Deloitte
UBS
QuintilesIMS

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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