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Colchicine - Generic Drug Details
What are the generic drug 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, Novast Labs, 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. Eleven 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: | 11 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 124 |
| Patent Applications: | 6,621 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for colchicine |
| 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
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | COL-PROBENECID | colchicine; probenecid | TABLET;ORAL | 084279-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Watson Labs | PROBEN-C | colchicine; probenecid | TABLET;ORAL | 085552-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | 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 | ||||
| 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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ISSN: 2162-2639
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Major Patent Expirations 2018 - 2019
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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