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COLCRYS Drug Profile
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Which patents cover Colcrys, and when can generic versions of Colcrys launch?
The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for COLCRYS
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 68 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,305 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COLCRYS |
| DailyMed Link: | COLCRYS at DailyMed |
Generic Entry Opportunity Date for COLCRYS
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for COLCRYS
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for COLCRYS
Synonyms for COLCRYS
| (+-)-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 |
| 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 |
| 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 COLCRYS
| 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 | ||||
| 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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Paragraph IV (Patent) Challenges for COLCRYS
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 0.6 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for COLCRYS
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.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,445,541 | Methods for concomitant administration of colchicine and a second active agent | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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