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Last Updated: August 14, 2020

DrugPatentWatch Database Preview

DOXERCALCIFEROL Drug Profile

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Which patents cover Doxercalciferol, and what generic alternatives are available?

Doxercalciferol is a drug marketed by Hikma, Rising, Akorn Inc, Amneal, Gland Pharma Ltd, Hospira Inc, Lupin Ltd, Meitheal, Sandoz Inc, and Sun Pharm. and is included in thirteen NDAs.

The generic ingredient in DOXERCALCIFEROL is doxercalciferol. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

US ANDA Litigation and Generic Entry Outlook for Doxercalciferol

A generic version of DOXERCALCIFEROL was approved as doxercalciferol by HIKMA on September 23rd, 2011.

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Drug patent expirations by year for DOXERCALCIFEROL
Drug Prices for DOXERCALCIFEROL

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Recent Clinical Trials for DOXERCALCIFEROL

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SponsorPhase
SanofiPhase 3
University of Colorado, DenverPhase 4
Children's Hospital Los AngelesPhase 4

See all DOXERCALCIFEROL clinical trials

Pharmacology for DOXERCALCIFEROL
Paragraph IV (Patent) Challenges for DOXERCALCIFEROL
Tradename Dosage Ingredient NDA Submissiondate
HECTOROL INJECTABLE;INJECTION doxercalciferol 021027 2011-12-28
HECTOROL CAPSULE;ORAL doxercalciferol 020862 2010-02-12
HECTOROL CAPSULE;ORAL doxercalciferol 020862 2009-03-25
HECTOROL INJECTABLE;INJECTION doxercalciferol 021027 2007-10-15

US Patents and Regulatory Information for DOXERCALCIFEROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 091433-001 Sep 23, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 091333-001 May 5, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929-002 Mar 28, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Rising DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518-001 Sep 9, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 210452-001 Sep 26, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203875-001 Nov 14, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929-001 May 7, 2015 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

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Serving leading biopharmaceutical companies globally:

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