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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.
US ANDA Litigation and Generic Entry Outlook for Mitigare
A generic version of MITIGARE was approved as colchicine by ALKEM LABS LTD on January 26th, 2020.
Summary for MITIGARE
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 83 |
| Patent Applications: | 4,340 |
| 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 |
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 |
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 | 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 | ||||
| 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 |
