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Generated: April 26, 2018

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Calcitriol - Generic Drug Details

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

Calcitriol
is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma Inc, Strides Pharma, Teva, West-ward Pharms Int, Validus Pharms, Abbvie, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, Teva Parenteral, and Galderma Labs Lp, and is included in eighteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for calcitriol. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for calcitriol
Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog
Medical Subject Heading (MeSH) Categories for calcitriol
Synonyms for calcitriol
(1?,3?,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol
(1alpha,3beta,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R)-5-hydroxy-1,5-dimethyl-hexyl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylene-cyclohexane-1,3-diol
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
(1R,3S,Z)-5-((E)-2-((1R,3aS,7aR)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methylhexahydro-1H-inden-4(2H)-ylidene)ethylidene)-4-methylenecyclohexane-1,3-diol
(1R,3S,Z)-5-(2-((1R,3aS,7aR,E)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)-4-methylenecyclohexane-1,3-diol
(1R,3S)-5-{2-[(1R,3aS,7aR)-1-((R)-5-Hydroxy-1,5-dimethyl-hexyl)-7a-methyl-octahydro-inden-4-ylidene]-ethylidene}-4-methylene-cyclohexane-1,3-diol
(1S,3R,5Z,7E)-9,10-seco-5,7,10(19)-cholestatriene-1,3,25-triol
(1S,3R,5Z,7E)-9,10-secocholesta-5,7,10-triene-1,3,25-triol
(1S,3R,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
(3b,5Z,7E)-9,10-Secocholesta-5,7,10(19)-trienetriol
(5Z,10-secocholesta-5,7,10(19)-triene-1.alpha.,3.beta.,25-triol
(5Z,7E)-(1S,3R)-9,10-seco-5,7,10(19)-cholestatriene-1,3,25-triol
(5Z,7E)-(1S,3R)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol
(5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1-alpha,3-beta,25-triol
(5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1alpha,3beta,25-triol
1 alpha,25-Dihydroxyvitamin D3
1-alpha-25-dihydroxyvitamin D3
1-alpha,-1,25-Dihydroxyvitamin D3
1-alpha,25-Dihydroxycholecalciferol
1-alpha,25-Dihydroxyvitamin D3
1,25 (OH)2 D3
1,25 Dihydroxycholecalciferol
1,25-(OH)2-D3
1,25-(OH)2D3
1,25-DHCC
1,25-dihydroxy vitamin D3
1,25-dihydroxy-20-epi-Vitamin D3
1,25-DIHYDROXYCHOLECALCIFEROL
1,25-Dihydroxycholecaliferol
1,25-Dihydroxyvitamin D
1,25-Dihydroxyvitamin D3
1,25(OH)2-20epi-D3
1,25(OH)2D3 & CD4
1,25(OH2)D3
1,25D3
1.Alpha.,25-Dihydroxy-26,27-hexadeuterovitamin D3
1.alpha.,25-dihydroxycholecalciferol
1.alpha.,25-Dihydroxyvitamin D(sub 3)
1|A,25-Dihydroxyvitamin D3
1000873-74-4
125338-24-1
1a,25-(OH)2D3
1a,25-Dihydroxycholecalciferol
1a,25-Dihydroxyvitamin D3
1alpha 25-dihydroxycholecalciferol
1alpha,25 dihydroxyvitamin D(3)
1alpha,25-Dihydroxycholecalciferol
1alpha,25-Dihydroxyvitamin D
1alpha,25-Dihydroxyvitamin D3
1alpha,25-dihydroxyvitamin D3 / 1alpha,25-dihydroxycholecalciferol / calcitriol
1alpha,25-Dihydroxyvitamin D3, >=97.0% (HPLC)
1alpha,25-Dihydroxyvitamin D3, >=99% (HPLC)
1alpha,25(OH)2-D3
1alpha,25(OH)2D3
1db1
20-epi-1alpha,25-dihydroxycholecaliferol
222C063
25-dihydroxycholecalciferol
32222-06-3
62019-EP2292592A1
62019-EP2298772A1
62019-EP2308828A2
62019-EP2308839A1
69878-52-0
9,?10-?SECOCHOLESTA-?5Z,?7E,?10(19)-?TRIENE-?1ALPHA,?3BETA,?25-?TRIOL
9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1alpha, 3beta, 25-triol
9,10-Seco(5Z,7E)-5,7,10(19)-cholestatriene-1alpha,3beta,25-triol
9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol, (1.alpha.,3.beta,.5Z,7E)-
9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol, (1.alpha.,3.beta,.5Z,7E)- & CD4
9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol, (1alpha,3beta,5Z,7E)-
AB00639957_07
AB00639957-06
AC-1859
AC1NQX1S
ACT06832
AKOS015961898
Ambap32222-06-3
Asentar
BC208534
BCBcMAP01_000160
BCP9000474
BCPP000304
BDBM50200182
BML2-E03
BRD-K27316855-001-06-7
BSPBio_001287
C01673
Calcijex
Calcitriol (API-31543, drug-induced alopecia), Cytotech Labs
Calcitriol (chemotherapy-induced alopecia)
Calcitriol (chemotherapy-induced alopecia), Cytotech Labs
Calcitriol (JAN/USP/INN)
Calcitriol (Rocaltrol)
Calcitriol [USAN:INN:BAN:JAN]
Calcitriol [USAN:USP:INN:BAN:JAN]
Calcitriol, European Pharmacopoeia (EP) Reference Standard
Calcitriolum
Calcitriolum [INN-Latin]
Cas Number 32222-06-3
CAS-32222-06-3
CCG-101001
CCRIS 5522
CD-2027
CHEBI:17823
CHEBI:93988
CHEMBL846
Cholecalci
Cholecalciferol, 1-alpha,25-dihydroxy-
CPD000466393
CS-0388
D00129
D0G2KU
D0T2PL
DB00136
Decostriol
Dihydroxyvitamin D3
DN 101
DN-101
DR002536
DSSTox_CID_2722
DSSTox_GSID_22722
DSSTox_RID_76700
DTXSID5022722
EINECS 250-963-8
FXC9231JVH
GMRQFYUYWCNGIN-NKMMMXOESA-N
GTPL2779
HMS1361A09
HMS1791A09
HMS1989A09
HMS2051F06
HMS2089N03
HMS2232D18
HMS3402A09
HSDB 3482
HY-10002
IDI1_033757
LMST03020258
LS-53093
MC-1288
MC1288
MFCD00867079
MLS000759536
MLS001424122
MolPort-002-045-698
NC00251
NCGC00161327-01
NCGC00161327-04
NSC-749776
NSC749776
OR109383
OR257675
OR257676
Panbonis
PubChem18818
PubChem19327
Ro 21-5535
Ro 215535
Ro-21-5535
Ro-215535
Rocaltrol
Rocaltrol (TN)
s1466
SC-17020
SCHEMBL3245
Silkis
SMR000466393
Soltriol
Spectrum5_002061
SR-01000946978
SR-01000946978-1
Synthetic vitamin D analog
Topitriol
Toptriol
Tox21_111988
U 49562
UNII-FXC9231JVH
Vectical
vit D
Vitamin D3, 1alpha, 25-Dihydroxy-
W-5161
ZINC100015048
ZX-AFC000310
Tentative approvals for CALCITRIOL
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.001MG/MLINJECTABLE;INJECTION
➤ Sign Up➤ Sign Up0.002MG/MLINJECTABLE;INJECTION

US Patents and Regulatory Information for calcitriol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Medcl CALCITRIOL calcitriol INJECTABLE;INJECTION 075766-001 Feb 20, 2003 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Akorn CALCITRIOL calcitriol INJECTABLE;INJECTION 078066-001 Jan 29, 2008 RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Strides Pharma CALCITRIOL calcitriol CAPSULE;ORAL 091356-001 Dec 12, 2014 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

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Expired US Patents for calcitriol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986 ➤ Sign Up ➤ Sign Up
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-002 Sep 25, 1986 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Chubb
AstraZeneca
US Department of Justice
Boehringer Ingelheim
Teva
US Army
Baxter

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