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Last Updated: July 10, 2020

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Calcitriol - Generic Drug Details

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What are the generic drug sources for calcitriol and what is the scope of freedom to operate?

Calcitriol is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma Inc, Hikma, Strides Pharma, Sun Pharm, Teva, Validus Pharms, Abbvie, Akorn, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Galderma Labs Lp, and Elysium, and is included in twenty-one 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. Eighteen suppliers are listed for this compound.

Drug Prices for calcitriol

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Drug Sales Revenue Trends for calcitriol

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Recent Clinical Trials for calcitriol

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SponsorPhase
Yale UniversityPhase 1
Ain Shams UniversityPhase 2/Phase 3
Nahda UniversityPhase 2/Phase 3

See all calcitriol clinical trials

Pharmacology for calcitriol
Medical Subject Heading (MeSH) Categories for calcitriol
Paragraph IV (Patent) Challenges for CALCITRIOL
Tradename Dosage Ingredient NDA Submissiondate
CALCIJEX INJECTABLE;INJECTION calcitriol 018874

US Patents and Regulatory Information for calcitriol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elysium CALCITRIOL calcitriol SOLUTION;ORAL 209798-001 Nov 21, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc CALCITRIOL calcitriol CAPSULE;ORAL 091174-002 May 24, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986 DISCN Yes No   Start Trial   Start Trial   Start Trial
Teva Parenteral CALCITRIOL calcitriol INJECTABLE;INJECTION 075823-002 Mar 31, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa CALCITRIOL calcitriol INJECTABLE;INJECTION 075836-002 Dec 31, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd CALCITRIOL calcitriol INJECTABLE;INJECTION 211030-001 Feb 3, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for calcitriol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986   Start Trial   Start Trial
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Harvard Business School
Colorcon
Mallinckrodt
Express Scripts

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 verification 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.