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Last Updated: November 15, 2019

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Calcipotriene - Generic Drug Details

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

Calcipotriene is the generic ingredient in three branded drugs marketed by Mayne Pharma, Glenmark Pharms, Tolmar, Leo Pharma As, Glenmark Pharms Inc, Acp Nimble, Fougera Pharms, Hi Tech Pharma, Novel Labs Inc, and Leo Pharm, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Calcipotriene has twenty-six patent family members in twelve countries.

There are twelve drug master file entries for calcipotriene. Fourteen suppliers are listed for this compound.

Summary for calcipotriene

International Patents:	26
US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	12
Suppliers / Packagers:	14
Bulk Api Vendors:	75
Clinical Trials:	28
Patent Applications:	7,419
Drug Prices:	Drug price trends for calcipotriene
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for calcipotriene
DailyMed Link:	calcipotriene at DailyMed

See drug prices for calcipotriene

Recent Clinical Trials for calcipotriene

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

Sponsor	Phase
Tulane University	Early Phase 1
Mayne Pharma International Pty Ltd	Early Phase 1
Massachusetts General Hospital	Phase 1

See all calcipotriene clinical trials

Recent Litigation for calcipotriene

Identify potential future generic entrants

District Court Litigation

Case Name	Date
LEO Pharma A/S v. Tolmar Inc.	2010-08-25
LEO Pharma A/S v. Tolmar Inc.	2010-04-06
Bone Care International LLC v. Pentech Pharmaceuticals, Inc.	2008-02-21

See all calcipotriene litigation

Pharmacology for calcipotriene

Drug Class	Vitamin D Analog

Synonyms for calcipotriene

(1?,3?,5Z,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol
(1\|A,3\|A,5E,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R,2E,4S)-4-Cyclopropyl-4-hydroxy-1-methyl-2-buten-1-yl]octahydro-7a-methyl-4H-inden-4-ylidene]ethylidene]-4-methylene-1,3-cyclohexanediol
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,1R)-4-cyclopropyl-4-hydroxy-1-methyl-but-2-enyl]-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-[(E,2R,5S)-5-cyclopropyl-5-hydroxypent-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)-1-[(E,2R)-5-cyclopropyl-5-hydroxypent-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,7aR)-1-[(E,2R,5S)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylenecyclohexane-1,3-diol
(1R,3S,5Z)-5-[(2E)-2-[(1R,7aR)-1-[(E,2R,5S)-5-cyclopropyl-5-hydroxypent-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,7aR)-1-[(E,2R,5S)-5-cyclopropyl-5-oxidanyl-pent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexane-1,3-diol
(1R,3S,Z)-5-(2-((1R,7aR,E)-1-((2R,5S,E)-5-cyclopropyl-5-hydroxypent-3-en-2-yl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)-4-methylenecyclohexane-1,3-diol
(1S,3R,5Z,7E,14beta,17alpha,22E,24S)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol
(1S,3R,5Z,7E,22E,24S)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol
(1S,3S,5E)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R,2E,4S)-4-Cyclopropyl-4-hydroxy-1-methyl-2-buten-1-yl]octahydro-7a-methyl-4H-inden-4-ylidene]ethylidene]-4-methylene-1,3-cyclohexanediol
(1S,5Z,7Z,17ALPHA,22E)-24-CYCLOPROPYL-9,10-SECOCHOLA-5,7,10,22-TETRAENE-1,3,24-TRIOL
(1S,5Z,7Z,17ALPHA,22E)-24-CYCLOPROPYL-9,10-SECOCHOLA-5,7,10,22-TETRAENE-1,3,24-TRIOL; 1-ALPHA,24S-(OH)2-22-ENE-26,27-DEHYDROVITAMIN D3
(22E)-(24R)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydro-20-epivitamin D3 / (22E)-(24R)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydro-20-epicholecalciferol
(22E)-(24S)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrovitamin D3 / (22E)-(24S)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrocholecalciferol / Calcipotriol
(5E,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol
(5E)-Calcipotriene
(5E)-Calcipotriol
(5Z,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol
(5Z,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol hydrate
(5Z,7E,22E)-(1S,3R,20S,24R)-26,27-cyclo-9,10-seco-5,7,10(19),22-cholestatetraene-1,3,24-triol
(5Z,7E,22E)-(1S,3R,24S)-26,27-cyclo-9,10-seco-5,7,10(19),22-cholestatetraene-1,3,24-triol
(5Z,7E,24S)-26,27-Cyclo-9,10-secocholesta-5,7,10(19),22-tetraene-1alpha,3beta,24-triol
(5Z)-5-[(2Z)-2-[1-[(E)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
1-ALPHA,24S-(OH)2-22-ENE-26,27-DEHYDROVITAMIN D3
1,24(OH)2-22-ene-24-cyclopropyl D3
1,3-Cyclohexanediol, 5-((2E)-2-((1R,3aS,7aR)-1-((1R,2E,4S)-4-cyclopropyl-4-hydroxy-1-methyl-2-buten-1-yl)octahydro-7a-methyl-4H-inden-4-ylidene)ethylidene)-4-methylene-, (1S,3S,5E)-
112828-00-9
112965-21-6
113082-99-8
143NQ3779B
147657-22-5
1s19
24207-EP2275420A1
24207-EP2295055A2
24207-EP2295416A2
24207-EP2298748A2
24207-EP2298764A1
24207-EP2298765A1
24207-EP2305640A2
24207-EP2305642A2
24207-EP2308861A1
24207-EP2311453A1
24207-EP2314590A1
5,6-trans-Calcipotriol
828C009
9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5E,7E,22E,24S)-
9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5Z,7E,22E,24S)-
9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5Z,7E,22E)-
9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-,(1-alpha,3-beta,5Z,7E,22E,24S)-
A802667
AB00698343-05
AC-4696
AC1NQZJ5
AC1NRC3V
AC1O455M
AC1O5L5S
AKOS005146500
AKOS015855239
AKOS024457248
AN-33413
BDBM50369964
BIDD:GT0282
BMS-181161
BRD-K56429665-001-03-9
Calcipotriene (USAN)
Calcipotriene [USAN]
CALCIPOTRIENE HYDRATE
Calcipotriol
Calcipotriol (JAN)
Calcipotriol [INN]
Calcipotriol hydrate
Calcipotriol, (5E)-
Calcipotriol, anhydrous
Calcipotriol, anhydrous impurity C [EP]
Calcipotriol, anhydrous specified impurity C [EP]
Calciptriol
Calciptriol, MC-903, Daivonex, Dovonex, Psorcutan
Calcitrene
CAS-112965-21-6
CCG-100949
CCRIS 7700
CHEBI:50749
CHEMBL1200666
CHEMBL1366876
CPD000466353
CS-0387
D01125
Daivonex
Davonex
DB02300
Divonex
Dovonex
Dovonex (TN)
DSSTox_CID_26648
DSSTox_GSID_46648
DSSTox_RID_81793
DTXSID0046648
Epitope ID:114242
FT-0082647
GTPL2778
HMS2051N11
HMS2089J08
HMS3269P03
HMS3713K08
HY-10001
LMST03020106
LMST03020107
LS-144707
LWQQLNNNIPYSNX-UROSTWAQSA-N
MC 903
MC-903
MC903
MFCD10567086
MLS000759467
MLS001424130
NC00199
NCGC00167465-01
NCGC00167465-02
NCGC00167837-01
O763
PRI 2201
PRI 2205
PRI-2205
Psorcutan
PubChem18810
PubChem19334
QRA3492A7Q
RTC-020913
SCHEMBL1131595
SCHEMBL13044528
SCHEMBL17430783
SCHEMBL2131847
SCHEMBL2853
SCHEMBL9360339
SMR000466353
Sorilux
SR-01000762910
SR-01000762910-3
SR-01000762910-4
STF-115469
TC-020913
Tox21_112469
Tox21_112469_1
U-0267
UNII-143NQ3779B
UNII-QRA3492A7Q
W-5148
ZINC3921872
ZINC77285174

Paragraph IV (Patent) Challenges for CALCIPOTRIENE

Tradename	Dosage	Ingredient	NDA	Submissiondate
DOVONEX	CREAM;TOPICAL	calcipotriene	020554	2009-12-02
DOVONEX	SOLUTION;TOPICAL	calcipotriene	020611	2006-05-19

US Patents and Regulatory Information for calcipotriene

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772-001	Jun 9, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Tolmar	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	077029-001	Nov 20, 2009	AT	RX	No	Yes	Start Trial	Start Trial				Start Trial
Fougera Pharms	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078305-001	May 6, 2008	AT	RX	No	No	Start Trial	Start Trial				Start Trial
Glenmark Pharms Inc	CALCIPOTRIENE	calcipotriene	OINTMENT;TOPICAL	090633-001	Mar 24, 2010		RX	No	Yes	Start Trial	Start Trial				Start Trial
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993		DISCN	Yes	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 calcipotriene

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	Start Trial	Start Trial
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	Start Trial	Start Trial
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993	Start Trial	Start Trial
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	Start Trial	Start Trial
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for calcipotriene

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Country	Patent Number	Estimated Expiration
Spain	2447301	Start Trial
European Patent Office	1917072	Start Trial
Australia	6069299	Start Trial
Japan	2008542353	Start Trial
Japan	4603164	Start Trial
>Country	>Patent Number	>Estimated Expiration

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