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Last Updated: December 5, 2019

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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 patent protection?

Doxercalciferol is the generic ingredient in two branded drugs marketed by Anda Repository, West-ward Pharms Int, Sanofi, Akorn Inc, Amneal Pharms Co, Gland Pharma Ltd, Hikma Pharms, Hospira Inc, Lupin Ltd, and Sandoz Inc, and is included in thirteen 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

See drug prices for doxercalciferol

Recent Clinical Trials for doxercalciferol

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

SponsorPhase
SanofiPhase 3
University of Colorado, DenverPhase 4
Loma Linda UniversityPhase 4

See all doxercalciferol clinical trials

Recent Litigation for doxercalciferol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Genzyme Corporation v. Anchen Pharmaceuticals Inc.2010-06-10
Bone Care International LLC v. Sandoz Inc.2009-07-16
Bone Care International LLC v. Pentech Pharmaceuticals, Inc.2008-02-21

See all doxercalciferol litigation

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
Synonyms for doxercalciferol
(1|A,3|A,5Z,7E,22E)- 9,10-Secoergosta-5,7,10(19),22-tetraene-1,3-diol
(1R,3S,5Z)-4-Methylene-5-[(2E)-2-[(1R,3aS,7aR)-octahydro-7?-methyl-1-[(1R,2E)-1,4,5-trimethyl-2-hexen-1-yl]-4H-inden-4-ylidene]ethylidene]-1,3-cyclohexanediol
(1R,3S,5Z)-4-Methylene-5-[(2E)-2-[(1R,3aS,7aR)-octahydro-7a-methyl-1-[(1R,2E)-1,4,5-trimethyl-2-hexen-1-yl]-4H-inden-4-ylidene]ethylidene]-1,3-cyclohexanediol
(1R,3S,5Z)-4-Methylene-5-[(2E)-2-[(1R,3aS,7aR)-octahydro-7alpha-methyl-1-[(1R,2E)-1,4,5-trimethyl-2-hexen-1-yl]-4H-inden-4-ylidene]ethylidene]-1,3-cyclohexanediol
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(E,1R,4R)-1,4,5-trimethylhex-2-enyl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylene-cyclohexane-1,3-diol
(1R,3S,Z)-5-(2-((1R,3aS,7aR,E)-1-((2R,5R,E)-5,6-dimethylhept-3-en-2-yl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)-4-methylenecyclohexane-1,3-diol
(1S,3R,5Z,7E,22E)-9,10-Secoergosta-5,7,10,22-tetraene-1,3-diol
(5Z,7E,22E)-(1S,3R)-9,10-seco-5,7,10(19),22-ergostatetraene-1,3-diol
(5Z,7E,22E)-9,10-Secoergosta-5,7,10(19),22-tetraene-1alpha,3beta-diol
1-alpha-hydroxyergocalciferol
1-alpha-Hydroxyvitamin D2
1-Hydroxyergocalciferol
1-Hydroxyvitamin D2
1?Hydroxy VitaMin D2
125285-48-5
127516-23-8
1alpha-hydroxy vitamin D2
1alpha-Hydroxyergocalciferol
1alpha-hydroxyvitamin D2
1alpha-hydroxyvitamin D2 / 1alpha-hydroxyergocalciferol
1alpha-OH-D2
1alpha-OHD2
1alphaOHD2
3DIZ9LF5Y9
42163-EP2298768A1
42163-EP2311808A1
42163-EP2311829A1
54573-75-0
573D750
87649-67-0
9,10-Secoergosta-5,7,10(19),22-tetraene-1,3-diol, (1-alpha,3-beta,5Z,7E,22E)-
9,10-Secoergosta-5,7,10(19),22-tetraene-1,3-diol, (1alpha,3beta,5Z,7E,22E)-
9,10-Secoergosta-5,7,10(19),22-tetraene-1,3-diol,(1-alpha,3-beta,5Z,7E,22E)
AC1NQY15
ACT06836
AKOS005146517
BCI-101
BRN 4716774
C08211
C28H44O2
CAS-54573-75-0
CHEBI:4712
CHEMBL1200810
CS-0395
D01009
Doxcercalciferol
Doxercalciferol (INN)
Doxercalciferol [INN]
Doxercalciferol [USAN:INN]
Doxercalciferol, >=98% (HPLC), solubility: >10 mg/mL in DMSO
Doxercalciferol, United States Pharmacopeia (USP) Reference Standard
Doxercalciferolum
DSSTox_CID_14214
DSSTox_GSID_34214
DSSTox_RID_79125
DTXSID1034214
GTPL2790
Hectorol
Hectorol (TN)
Hectorol; TSA 840
HKXBNHCUPKIYDM-CGMHZMFXSA-N
HSCI1_000341
HY-32348
LMST03010028
LS-144720
MFCD00871065
MolPort-018-493-676
NCGC00182058-03
PubChem18823
SC-77181
SCHEMBL322422
Tox21_112978
TSA 840
UNII-3DIZ9LF5Y9
V1826
Vitamin D2, 1alpha-Hydroxy-
W-5181
ZINC4641374
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
Akorn Inc DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929-002 Mar 28, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Akorn Inc DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929-001 May 7, 2015 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 020862-002 Apr 23, 2004   Start Trial   Start Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999   Start Trial   Start Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.