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Colchicine - Generic Drug Details

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What are the generic sources for colchicine and what is the scope of colchicine freedom to operate?
Colchicine is the generic ingredient in seven branded drugs marketed by Hikma Intl Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms Inc, Beecham, Impax Labs, Ingenus Pharms Nj, Sandoz, and Lederle, and is included in twelve NDAs. There are twenty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for colchicine. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for colchicine

US Patents:	22
Tradenames:	7
Applicants:	10
NDAs:	12
Drug Master File Entries:	16
Suppliers / Packagers:	12
Bulk Api Vendors:	68
Clinical Trials:	121
Patent Applications:	6,625
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for colchicine
DailyMed Link:	colchicine at DailyMed

Pharmacology for colchicine

Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions

Medical Subject Heading (MeSH) Categories for colchicine

Gout Suppressants
Tubulin Modulators

Synonyms for colchicine

(+-)-COLCHICINE
(S)-colchicin
(S)-colchicina
(S)-colchicine
(S)-N-(1,2,3,10-tetramethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl)acetamide
(S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl) acetamide
(S)-N-(5,6,7,9-Tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl)acetamide
078C484
24218-EP2275412A1
24218-EP2277865A1
24218-EP2281815A1
24218-EP2301933A1
24218-EP2301940A1
24218-EP2305219A1
24218-EP2305640A2
24218-EP2311827A1
24218-EP2314590A1
30512-31-3
3B1-006030
4lzr
4o2b
5843-86-7
64-86-8
7-alpha-H-Colchicine
7.alpha.H-Colchicine
7alphaH-Colchicine
AB2000548
AC1L1LXO
Acetamide, N-((7S)-5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(a)heptalen-7-yl)-
Acetamide, N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(a)heptalen-7-yl)-, (S)-
Acetamide, N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(alpha)heptalen-7-yl)-
Acetamide, N-[(7S)-5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl]-
Acetamide,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(.alpha.)heptalen-7-yl)-
Acetamide,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[.alpha.]heptalen-7-yl)-
Acetamide,N-[(7S)-5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl]-
ACon1_000353
AI3-31149
AKOS001582887
AN-16005
API0002098
AS-13686
BB_NC-0737
BDBM50014846
Benzo(a)heptalen-9(5H)-one
Benzo(a)heptalen-9(5H)-one, 7-acetamido-6,7-dihydro-1,2,3,10-tetramethoxy-
Benzo[a]heptalen-9(5H)-one,7-dihydro-1,2,3,10-tetramethoxy-
BG0155
binds to tubulin
binds to tubulin; inhibits microtubular assembly
BPBio1_000535
BRD-K00259736-001-06-5
BSPBio_000485
BSPBio_002083
BT000683
C 9754
C-21700
C-7100
C07592
C22H25NO6
CAS-64-86-8
CC-25958
CCG-39910
CCRIS 691
CHEBI:27882
CHEMBL107
CJ-04376
Colchicin
Colchicin [German]
Colchicina
Colchicina [Italian]
Colchicine (JP15/USP)
Colchicine (JP17/USP)
Colchicine (TN)
Colchicine [JAN]
Colchicine [USP:JAN]
Colchicine for system suitability, European Pharmacopoeia (EP) Reference Standard
Colchicine, (+-)-Isomer
Colchicine, (European Pharmacopoeia (EP) Reference Standard)
Colchicine, (R)-Isomer
Colchicine, >=95% (HPLC), powder
Colchicine, >=96.0% (HPLC)
Colchicine, 95% dry weight 1g
Colchicine, BioReagent, plant cell culture tested, >=95% (HPLC)
Colchicine, Colchicum autumnale
Colchicine, pharmaceutical secondary standard; traceable to USP, PhEur, BP
Colchicine, United States Pharmacopeia (USP) Reference Standard
Colchicinum
Colchineos
Colchineos;Colchisol;Colcin
Colchisol
Colchysat
Colcin
Colcrys
Colsaloid
Colstat
Condylon
CS-1141
D00570
D09DHY
DB08117
DivK1c_000753
DR002336
DSSTox_CID_4845
DSSTox_GSID_24845
DSSTox_RID_77551
DTXSID5024845
EBD2156734
EINECS 200-598-5
EU-0100310
FT-0603187
Goutnil
GTPL2367
HE066732
HMS1569I07
HMS1920A08
HMS2091G16
HMS2096I07
HMS2231C05
HMS3260N22
HMS502F15
HSDB 3044
HY-16569
IAKHMKGGTNLKSZ-INIZCTEOSA-N
IDI1_000753
inhibits microtubular assembly
J10109
KBio1_000753
KBio2_001322
KBio2_003890
KBio2_006458
KBio3_001303
KBioGR_000856
KBioSS_001322
KM0881
Kolkicin
LOC
Lopac0_000310
LP00310
LS-279
M01514
MCULE-1568647156
MCULE-7858118731
MEGxp0_001879
MFCD00078484
MLS001055448
MLS001055448-02
MLS001304089
MLS002153786
MolPort-001-742-594
MPC-004
N-((7S)-5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(a)heptalen-7-yl)- acetamide
N-((7S)-5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(a)heptalen-7-yl)-acetamide
N-(5,6,7,9-Tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo(a)heptalen-7-yl)acetamide
N-(5,6,7,9-Tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[.alpha.]heptalen-7-yl)-acetamide
N-[(10S)-3,4,5,14-tetramethoxy-13-oxotricyclo[9.5.0.0?,?]hexadeca-1(16),2(7),3,5,11,14-hexaen-10-yl]ethanimidic acid
N-[(10S)-3,4,5,14-TETRAMETHOXY-13-OXOTRICYCLO[9.5.0.0(2),?]HEXADECA-1(16),2(7),3,5,11,14-HEXAEN-10-YL]ACETAMIDE
N-[(7S)-1,2,3,10-tetramethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide
N-[(7S)-1,2,3,10-tetramethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide;
N-[(7S)-1,2,3,10-tetramethoxy-9-oxo-6,7-dihydro-5H-benzo[a]heptalen-7-yl]acetamide
N-[(7S)-1,2,3,10-tetramethoxy-9-oxo-6,7-dihydro-5H-benzo[d]heptalen-7-yl]acetamide
N-[(7S)-5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl]acetamide
N-Acetyl trimethylcolchicinic acid methylether
N1721
NCGC00025125-01
NCGC00025125-02
NCGC00025125-03
NCGC00025125-04
NCGC00025125-05
NCGC00025125-06
NCGC00025125-07
NCGC00025125-08
NCGC00025125-09
NCGC00025125-10
NCGC00025125-11
NCGC00025125-12
NCGC00025125-13
NCGC00025125-14
NCGC00025125-15
NCGC00025125-18
NCGC00025125-20
NCGC00169157-01
NCGC00169157-02
NCGC00169157-03
NCGC00254359-01
NCGC00259096-01
NCGC00260995-01
NCI60_041659
NINDS_000753
NSC 757
NSC-756702
NSC-757
NSC756702
NSC757
Pharmakon1600-01500205
PL008023
Prestwick_695
Prestwick0_000363
Prestwick1_000363
Prestwick2_000363
Prestwick3_000363
RL04473
SBI-0050298.P004
SC-11404
SCHEMBL8469
SDCCGMLS-0066633.P001
SML2Y3J35T
SMR000058323
SPBio_000289
SPBio_002406
Spectrum_000842
SPECTRUM1500205
Spectrum2_000075
Spectrum3_000362
Spectrum4_000298
Spectrum5_000787
spindle poison
SR-01000597576
SR-01000597576-3
Tocris-1364
Tox21_110947
Tox21_110947_1
Tox21_201547
Tox21_300582
Tox21_500310
UNII-SML2Y3J35T
UPCMLD-DP065
UPCMLD-DP065:001
WLN: L B677 MV&T&J CO1 DO1 EO1 JMV1 NO1
ZB014630
ZINC621853
ZX-AFC000369

Tentative approvals for COLCHICINE

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	0.6MG	TABLET;ORAL
➤ Sign Up	➤ Sign Up	0.6MG	TABLET;ORAL

US Patents and Regulatory Information for colchicine

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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
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Lederle	PROBENECID W/ COLCHICINE	colchicine; probenecid	TABLET;ORAL	086954-001	Approved Prior to Jan 1, 1982		DISCN	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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Non-Orange Book US Patents for colchicine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.