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MITIGARE Drug Profile

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When do Mitigare patents expire, and what generic alternatives are available?

Mitigare is a drug marketed by Hikma Intl Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in MITIGARE is colchicine. There are sixteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for MITIGARE

US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	82
Patent Applications:	4,300
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MITIGARE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MITIGARE
DailyMed Link:	MITIGARE at DailyMed

See drug prices for MITIGARE

Recent Litigation for MITIGARE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Hikma Pharmaceuticals USA Inc. v. Micro Labs Ltd.	2019-05-10
Hikma Pharmaceuticals USA Inc. v. Granules Pharmaceuticals, Inc., USA	2018-01-12

See all MITIGARE litigation

Pharmacology for MITIGARE

Mechanism of Action

Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions

Synonyms for MITIGARE

(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

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

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 MITIGARE

Tradename	Dosage	Ingredient	NDA	Submissiondate
MITIGARE	CAPSULE;ORAL	colchicine	204820	2016-06-10

US Patents and Regulatory Information for MITIGARE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014		RX	Yes	Yes