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Last Updated: July 15, 2020

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CALCITRIOL Drug Profile

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When do Calcitriol patents expire, and what generic alternatives are available?

Calcitriol is a drug marketed by Amneal Pharms, Bionpharma Inc, Hikma, Strides Pharma, Sun Pharm, Teva, Akorn, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Rockwell Medcl, Sagent Pharms, Teva Parenteral, and Elysium. and is included in seventeen NDAs.

The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

US ANDA Litigation and Generic Entry Outlook for Calcitriol

A generic version of CALCITRIOL was approved as calcitriol by TEVA on October 12th, 2001.

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Drug patent expirations by year for CALCITRIOL
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
Hikma CALCITRIOL calcitriol SOLUTION;ORAL 076242-001 Jul 18, 2003 AA RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms CALCITRIOL calcitriol CAPSULE;ORAL 203289-002 Jun 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Medcl CALCITRIOL calcitriol INJECTABLE;INJECTION 075766-001 Feb 20, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Sagent Pharms CALCITRIOL calcitriol INJECTABLE;INJECTION 077102-001 Feb 8, 2006 DISCN 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
Bionpharma Inc CALCITRIOL calcitriol CAPSULE;ORAL 091174-002 May 24, 2013 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

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Medtronic
Express Scripts
Dow
Harvard Business School

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