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Last Updated: July 13, 2024

DOXERCALCIFEROL - Generic Drug Details


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

Doxercalciferol is the generic ingredient in two branded drugs marketed by Avet, Hikma, Rising, Sanofi, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for doxercalciferol. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

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

Generic filers with tentative approvals for DOXERCALCIFEROL
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up2MCG/MLINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Lupin Ltd DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 210801-001 Nov 1, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518-003 Sep 9, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203875-002 Nov 14, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avet DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 205360-003 Sep 15, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avet DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 205360-002 Sep 15, 2020 AB RX 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

Expired US Patents for DOXERCALCIFEROL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Sign Up ⤷  Sign Up
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 ⤷  Sign Up ⤷  Sign Up
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Sign Up ⤷  Sign Up
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-002 Apr 6, 2000 ⤷  Sign Up ⤷  Sign Up
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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