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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 calcipotriene 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:	72
Clinical Trials:	27
Patent Applications:	7,179
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

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

US Patents and Regulatory Information for calcipotriene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Inc	CALCIPOTRIENE	calcipotriene	OINTMENT;TOPICAL	090633-001	Mar 24, 2010		RX	No	Yes
Hi Tech Pharma	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	077579-001	Nov 19, 2009	AT	RX	No	No
Tolmar	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	077029-001	Nov 20, 2009	AT	RX	No	Yes
Fougera Pharms	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078305-001	May 6, 2008	AT	RX	No	No
Glenmark Pharms	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772-001	Jun 9, 2015	AB	RX	No	No
Tolmar	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	200935-001	May 30, 2012	AB	RX	No	No
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes			Y

Expired US Patents for calcipotriene

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

International Patents for calcipotriene

Country	Patent Number	Estimated Expiration
Canada	2333869
Germany	69937802
Spain	2447301
Denmark	1112062
World Intellectual Property Organization (WIPO)	2006129161
World Intellectual Property Organization (WIPO)	0015193
Japan	5612263