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Last Updated: March 19, 2024

Doxercalciferol - Generic Drug Details


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What are the generic drug sources for doxercalciferol and what is the scope of patent protection?

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

See drug prices for doxercalciferol

Recent Clinical Trials for doxercalciferol

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

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

See all doxercalciferol clinical trials

Generic filers with tentative approvals for DOXERCALCIFEROL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial2MCG/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
Sandoz DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 200926-001 Feb 4, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518-003 Sep 9, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 doxercalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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