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Colchicine - Generic Drug Details
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. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for colchicine
| International Patents: | 3 |
| US Patents: | 24 |
| Tradenames: | 9 |
| Applicants: | 18 |
| NDAs: | 20 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 17 |
| Bulk Api Vendors: | 81 |
| Clinical Trials: | 135 |
| Patent Applications: | 6,557 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for colchicine |
| Drug Sales Revenues: | Drug sales revenues for colchicine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for colchicine |
| DailyMed Link: | colchicine at DailyMed |
Recent Clinical Trials for colchicine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dyve Biosciences, Inc. | Phase 2 |
| LG Chem | Phase 1 |
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
Recent Litigation for colchicine
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 |
Generic filers with tentative approvals for COLCHICINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 0.6MG | TABLET;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
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
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 | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Merck | COLBENEMID | colchicine; probenecid | TABLET;ORAL | 012383-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Lederle | PROBENECID W/ COLCHICINE | colchicine; probenecid | TABLET;ORAL | 086954-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | 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 |
International Patents for colchicine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2019126579 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2017156392 | Start Trial |
| European Patent Office | 3426227 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.