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Last Updated: August 13, 2020

DrugPatentWatch Database Preview

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. Nineteen 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
Nahda UniversityPhase 2/Phase 3
Ain Shams UniversityPhase 2/Phase 3

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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
Validus Pharms ROCALTROL calcitriol SOLUTION;ORAL 021068-001 Nov 20, 1998 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Akorn CALCITRIOL calcitriol INJECTABLE;INJECTION 078066-001 Jan 29, 2008 AP RX No Yes   Start Trial   Start Trial   Start Trial
Amneal Pharms CALCITRIOL calcitriol CAPSULE;ORAL 203289-001 Jun 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma CALCITRIOL calcitriol CAPSULE;ORAL 091356-002 Dec 12, 2014 AB 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
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-002 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 018874-002 Sep 25, 1986   Start Trial   Start Trial
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-001 Approved Prior to Jan 1, 1982   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:

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AstraZeneca

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