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Last Updated: November 22, 2024

DOXERCALCIFEROL Drug Patent Profile


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

Doxercalciferol is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm. and is included in sixteen 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Doxercalciferol

A generic version of DOXERCALCIFEROL was approved as doxercalciferol by HIKMA on August 30th, 2013.

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Summary for DOXERCALCIFEROL
Drug patent expirations by year for DOXERCALCIFEROL
Drug Prices for DOXERCALCIFEROL

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Recent Clinical Trials for DOXERCALCIFEROL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SanofiPhase 3
OPKO Ireland Global Holdings Ltd.Phase 3
OPKO Health, Inc.Phase 3

See all DOXERCALCIFEROL clinical trials

Pharmacology for DOXERCALCIFEROL
Drug ClassVitamin D2 Analog
Paragraph IV (Patent) Challenges for DOXERCALCIFEROL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HECTOROL Injection doxercalciferol 2 mcg/mL, 1 mL in 2 mL vial 021027 1 2011-12-28
HECTOROL Capsules doxercalciferol 1 mcg 020862 1 2010-02-12
HECTOROL Capsules doxercalciferol 0.5 mcg and 2.5 mcg 020862 1 2009-03-25
HECTOROL Injection doxercalciferol 2 mcg/mL, 2 mL ampules 021027 1 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
Avet DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 205360-001 Sep 15, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 210452-001 Sep 26, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 091333-001 May 5, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518-001 Sep 9, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 091433-001 Sep 23, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 208974-002 May 24, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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