Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

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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 freedom to operate?

Colchicine is the generic ingredient in nine branded drugs marketed by Par Pharm Inc, Hikma Intl Pharms, Avion Pharms, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Mylan, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms Inc, Beecham, Impax Labs, Novast Labs, Sandoz, and Lederle, and is included in twenty NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colchicine has three patent family members in two countries.

There are sixteen drug master file entries for colchicine. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for COLCHICINE

See drug prices for COLCHICINE

Drug Sales Revenue Trends for COLCHICINE

See drug sales revenues for COLCHICINE

Recent Clinical Trials for COLCHICINE

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

SponsorPhase
Dyve Biosciences, Inc.Phase 2
LG ChemPhase 1
Assistance Publique - Hôpitaux de ParisPhase 3

See all COLCHICINE clinical trials

Recent Litigation for COLCHICINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Hikma Pharmaceuticals USA Inc. v. Micro Labs Ltd.2019-05-10
TAKEDA PHARMACEUTICALS U.S.A., INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2018-03-28
Takeda Pharmaceuticals U.S.A., Inc. v. Zydus Pharmaceuticals (USA) Inc.2018-03-27

See all COLCHICINE litigation

Generic filers with tentative approvals for COLCHICINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.6MGTABLET;ORAL

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 COLCHICINE
Medical Subject Heading (MeSH) Categories for COLCHICINE
Synonyms for 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
4lzr
4o2b
5843-86-7
64-86-8
7-alpha-H-Colchicine
7.alpha.H-Colchicine
7alphaH-Colchicine
A3324
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)-
ACon1_000353
AI3-31149
AK167930
AKOS001582887
AN-16005
API0002098
AS-13686
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; inhibits microtubular assembly
BPBio1_000535
BRD-K00259736-001-06-5
BRD-K00259736-001-10-7
BSPBio_000485
BSPBio_002083
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 (JP17/USP)
Colchicine (TN)
Colchicine [JAN]
Colchicine [USP:JAN]
Colchicine for system suitability, European Pharmacopoeia (EP) Reference Standard
Colchicine, (European Pharmacopoeia (EP) Reference Standard)
Colchicine, >=95% (HPLC), powder
Colchicine, >=96.0% (HPLC)
Colchicine, BioReagent, plant cell culture tested, >=95% (HPLC)
Colchicine, Colchicum autumnale
Colchicine, Pharmaceutical Secondary Standard; Certified Reference Material
Colchicine, United States Pharmacopeia (USP) Reference Standard
Colchicinum
Colchineos
Colchineos;Colchisol;Colcin
Colchisol
Colchysat
Colcin
Colcrys
Colsaloid
Colstat
Condylon
CS-1141
D00570
DB08117
DivK1c_000753
DSSTox_CID_4845
DSSTox_GSID_24845
DSSTox_RID_77551
DTXSID5024845
EBD2156734
EC 200-598-5
EINECS 200-598-5
EU-0100310
FT-0603187
Goutnil
GTPL2367
HMS1569I07
HMS1920A08
HMS2091G16
HMS2096I07
HMS2231C05
HMS3260N22
HMS3713I07
HMS502F15
HSDB 3044
HY-16569
IAKHMKGGTNLKSZ-INIZCTEOSA-N
IDI1_000753
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
Mitigare
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-(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-[(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)-1,2,3,10-Tetramethoxy-9-Oxo-6,7-Dihydro-5h-Benzo[d]heptalen-7-Yl]ethanamide
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
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-01000075794
SR-01000075794-1
SR-01000075794-3
SR-01000075794-6
SR-01000075794-7
SR-01000597576
SR-01000597576-1
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
Paragraph IV (Patent) Challenges for COLCHICINE
Tradename Dosage Ingredient NDA Submissiondate
COLCRYS TABLET;ORAL colchicine 022352 2019-07-19
MITIGARE CAPSULE;ORAL colchicine 204820 2016-06-10
COLCRYS TABLET;ORAL colchicine 022352 2011-12-23

US Patents and Regulatory Information for COLCHICINE

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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc PROBENECID AND COLCHICINE colchicine; probenecid TABLET;ORAL 083734-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Express Scripts
Mallinckrodt
McKinsey
Boehringer Ingelheim

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.