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Last Updated: October 18, 2019

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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 patent protection?

Calcitriol is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma Inc, Strides Pharma, Sun Pharm, Teva, West-ward Pharms Int, Validus Pharms, Abbvie, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Galderma Labs Lp, and Invatech Pharma, and is included in twenty 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 suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for calcitriol

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Drug Sales Revenue Trends for calcitriol

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Recent Clinical Trials for calcitriol

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SponsorPhase
Florence Nightingale Hospital, IstanbulN/A
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 2
St Joseph University, Beirut, LebanonPhase 2/Phase 3

See all calcitriol clinical trials

Recent Litigation for calcitriol

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District Court Litigation
Case NameDate
Bone Care International LLC v. Pentech Pharmaceuticals, Inc.2008-02-21

See all calcitriol litigation

Generic filers with tentative approvals for CALCITRIOL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.002MG/MLINJECTABLE;INJECTION
  Start Trial  Start Trial0.001MG/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 calcitriol
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-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
5-{2-[1-(5-HYDROXY-1,5-DIMETHYL-HEXYL)-7A-METHYL-OCTAHYDRO-INDEN-4-YLIDENE]-ETHYLIDENE}-4-METHYLENE-CYCLOHEXANE-1,3-DIOL
62019-EP2292592A1
62019-EP2298772A1
62019-EP2308828A2
62019-EP2308839A1
69878-52-0
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
Asentar
BC208534
BCBcMAP01_000160
BCP9000474
BCPP000304
BDBM50200182
BML2-E03
BRD-K27316855-001-06-7
BRD-K27316855-001-19-0
BSPBio_001287
C01673
Calcijex
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
DB00136
Decostriol
dihydroxy-vitamin D3
Dihydroxyvitamin D3
DN 101
DN-101
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
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-01000759361
SR-01000759361-4
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

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
Teva CALCITRIOL calcitriol CAPSULE;ORAL 075765-002 Oct 12, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm CALCITRIOL calcitriol CAPSULE;ORAL 204556-002 Feb 21, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Parenteral CALCITRIOL calcitriol INJECTABLE;INJECTION 075823-001 Mar 31, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-001 Sep 25, 1986 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Validus Pharms ROCALTROL calcitriol SOLUTION;ORAL 021068-001 Nov 20, 1998 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie CALCIJEX calcitriol INJECTABLE;INJECTION 018874-002 Sep 25, 1986 DISCN Yes No   Start Trial   Start Trial Y   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 calcitriol

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