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Last Updated: December 3, 2021

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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 Avet, Hikma Pharms, Rising, Sanofi, Akorn, Amneal, Gland Pharma Ltd, Hikma, Hospira Inc, Lupin Ltd, Meitheal, Sandoz Inc, and Sun Pharm, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for doxercalciferol. Eleven 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
⤷  Try it Free⤷  Try it Free2MCG/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
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-002 Apr 6, 2000 AP RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hikma Pharms DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 091433-002 Jan 14, 2014 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 208975-001 May 24, 2017 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 208974-001 May 24, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929-002 Mar 28, 2016 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 INJECTABLE;INJECTION 021027-002 Apr 6, 2000 ⤷  Try it Free ⤷  Try it Free
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Try it Free ⤷  Try it Free
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ⤷  Try it Free ⤷  Try it Free
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 ⤷  Try it Free ⤷  Try it Free
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Mallinckrodt

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