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Last Updated: August 14, 2020

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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 Hikma, Rising, Sanofi, Akorn Inc, Amneal, Gland Pharma Ltd, Hospira Inc, Lupin Ltd, Meitheal, Sandoz Inc, and Sun Pharm, and is included in fifteen 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
University of Colorado, DenverPhase 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 4

See all doxercalciferol clinical trials

Generic filers with tentative approvals for DOXERCALCIFEROL
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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
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
Sandoz Inc DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 200926-001 Feb 4, 2014 AP 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
Rising DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518-002 Sep 9, 2016 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
>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   Start Trial   Start Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004   Start Trial   Start Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999   Start Trial   Start Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-003 Jul 13, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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