bendamustine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives 302 16506-27-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bendamustine
  • bendamustine hydrochloride
  • treanda
  • bendamustine HCl
A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.
  • Molecular weight: 358.26
  • Formula: C16H21Cl2N3O2
  • CLOGP: 3.24
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 58.36
  • ALOGS: -3.76
  • ROTB: 9

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.26 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.49 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.05 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.41 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 20, 2008 FDA CEPHALON

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pyrexia 573.57 54.62 241 2583 53467 2301794
Febrile neutropenia 564.58 54.62 160 2664 10722 2344539
Pancytopenia 441.97 54.62 134 2690 11318 2343943
Neutropenia 418.64 54.62 150 2674 21398 2333863
Pneumonia 298.85 54.62 150 2674 49146 2306115
Progressive multifocal leukoencephalopathy 267.71 54.62 64 2760 2148 2353113
Thrombocytopenia 260.85 54.62 103 2721 19028 2336233
Rash 231.28 54.62 135 2689 59423 2295838
Cytomegalovirus infection 205.73 54.62 54 2770 2659 2352602
Neutrophil count decreased 182.50 54.62 60 2764 6507 2348754
Chronic lymphocytic leukaemia 179.36 54.62 36 2788 519 2354742
Sepsis 178.83 54.62 78 2746 18410 2336851
Plasma cell myeloma 177.60 54.62 62 2762 8071 2347190
Lymphocyte count decreased 176.00 54.62 50 2774 3313 2351948
Off label use 173.72 54.62 122 2702 73476 2281785
Anaemia 153.62 54.62 86 2738 34706 2320555
Acute kidney injury 144.82 54.62 77 2747 28045 2327216
Tumour lysis syndrome 139.80 54.62 33 2791 1042 2354219
Vomiting 131.09 54.62 102 2722 71500 2283761
Atrial fibrillation 129.45 54.62 57 2767 13711 2341550
Platelet count decreased 125.00 54.62 58 2766 15755 2339506
Herpes zoster 123.94 54.62 50 2774 9675 2345586
Prescribed underdose 123.07 54.62 34 2790 2028 2353233
Nausea 120.79 54.62 118 2706 112071 2243190
Dehydration 120.22 54.62 63 2761 22232 2333029
White blood cell count decreased 114.23 54.62 57 2767 18151 2337110
Diarrhoea 109.19 54.62 98 2726 83466 2271795
Non-Hodgkin's lymphoma recurrent 107.05 54.62 17 2807 53 2355208
Pneumocystis jirovecii pneumonia 106.37 54.62 31 2793 2242 2353019
Disease progression 99.84 54.62 51 2773 17044 2338217
Lymphopenia 99.70 54.62 30 2794 2424 2352837
Pleural effusion 99.05 54.62 45 2779 11623 2343638
Non-Hodgkin's lymphoma 97.88 54.62 24 2800 891 2354370
General physical health deterioration 93.79 54.62 46 2778 14093 2341168
Myelodysplastic syndrome 89.97 54.62 28 2796 2532 2352729
Diffuse large B-cell lymphoma 88.92 54.62 22 2802 848 2354413
Hypotension 88.43 54.62 59 2765 32377 2322884
Product use in unapproved indication 88.17 54.62 41 2783 11159 2344102
Chills 86.75 54.62 45 2779 15507 2339754
Infection 86.01 54.62 47 2777 17982 2337279
Blood lactate dehydrogenase increased 85.40 54.62 29 2795 3455 2351806
Rash maculo-papular 83.50 54.62 30 2794 4222 2351039
Therapy partial responder 83.20 54.62 18 2806 379 2354882
Autoimmune haemolytic anaemia 82.31 54.62 20 2804 714 2354547
Pneumonitis 81.21 54.62 29 2795 4010 2351251
Venoocclusive liver disease 80.78 54.62 19 2805 589 2354672
Infusion related reaction 80.65 54.62 37 2787 9759 2345502
Varicella zoster virus infection 79.36 54.62 17 2807 341 2354920
CD4 lymphocytes decreased 78.35 54.62 17 2807 363 2354898
Extravasation 76.37 54.62 19 2805 749 2354512
Leukopenia 76.15 54.62 36 2788 10160 2345101
Enterococcal sepsis 74.32 54.62 14 2810 141 2355120
Non-small cell lung cancer 71.39 54.62 17 2807 556 2354705
Gastrointestinal fungal infection 71.38 54.62 12 2812 58 2355203
Asthenia 71.05 54.62 60 2764 46866 2308395
Infusion site pain 68.73 54.62 19 2805 1133 2354128
Bone marrow failure 68.14 54.62 28 2796 5658 2349603
Pneumonia fungal 66.94 54.62 15 2809 373 2354888
Plasma cell leukaemia 66.18 54.62 13 2811 166 2355095
Sinus polyp 63.72 54.62 11 2813 64 2355197
Haemolytic anaemia 63.68 54.62 20 2804 1861 2353400
Mucosal inflammation 63.53 54.62 26 2798 5198 2350063
Dyspnoea 63.14 54.62 71 2753 78662 2276599
Pulmonary mycosis 62.90 54.62 12 2812 130 2355131
Respiratory tract infection 62.82 54.62 24 2800 4005 2351256
Malignant neoplasm progression 61.64 54.62 33 2791 12095 2343166
Hypercalcaemia 61.26 54.62 21 2803 2571 2352690
Decreased appetite 61.05 54.62 45 2779 28846 2326415
Fear of injection 58.76 54.62 16 2808 901 2354360
Respiratory failure 58.26 54.62 33 2791 13495 2341766
Cytopenia 57.25 54.62 16 2808 993 2354268
Stomatitis 56.70 54.62 29 2795 9681 2345580
Syncope 56.54 54.62 35 2789 16840 2338421
Mucosal erosion 56.52 54.62 12 2812 230 2355031
Vasculitis 55.64 54.62 19 2805 2299 2352962

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 1092.52 43.67 334 4241 10766 1731440
Pyrexia 852.38 43.67 409 4166 45991 1696215
Pneumonia 497.12 43.67 286 4289 45896 1696310
Neutropenia 480.22 43.67 208 4367 18052 1724154
Pancytopenia 408.46 43.67 162 4413 11195 1731011
Tumour lysis syndrome 354.01 43.67 93 4482 1658 1740548
Rash 305.04 43.67 197 4378 38496 1703710
Myelodysplastic syndrome 291.88 43.67 92 4483 3197 1739009
Thrombocytopenia 285.53 43.67 153 4422 21096 1721110
Sepsis 266.78 43.67 142 4433 19296 1722910
Progressive multifocal leukoencephalopathy 246.59 43.67 69 4506 1570 1740636
Lymphocyte count decreased 243.81 43.67 73 4502 2125 1740081
Chills 242.02 43.67 113 4462 11574 1730632
Neutrophil count decreased 225.94 43.67 89 4486 5992 1736214
Cytomegalovirus infection 218.53 43.67 74 4501 3227 1738979
Off label use 217.47 43.67 160 4415 38411 1703795
Product use in unapproved indication 207.10 43.67 95 4480 9327 1732879
Anaemia 202.45 43.67 138 4437 29319 1712887
Disease progression 184.21 43.67 107 4468 17156 1725050
Neutropenic sepsis 176.03 43.67 52 4523 1440 1740766
Septic shock 172.61 43.67 80 4495 8029 1734177
Prescribed underdose 162.47 43.67 49 4526 1459 1740747
Chronic lymphocytic leukaemia 160.09 43.67 43 4532 833 1741373
Squamous cell carcinoma 152.06 43.67 49 4526 1822 1740384
Infection 148.90 43.67 83 4492 12277 1729929
Infusion related reaction 146.38 43.67 67 4508 6526 1735680
Acute kidney injury 140.54 43.67 119 4456 34825 1707381
Pneumocystis jirovecii pneumonia 138.98 43.67 49 4526 2407 1739799
White blood cell count decreased 133.51 43.67 79 4496 13070 1729136
Malignant neoplasm progression 133.23 43.67 81 4494 14077 1728129
Atrial fibrillation 130.89 43.67 82 4493 15029 1727177
Leukopenia 130.33 43.67 67 4508 8413 1733793
General physical health deterioration 123.27 43.67 75 4500 13043 1729163
Autoimmune haemolytic anaemia 122.85 43.67 34 4541 739 1741467
Dyspnoea 122.84 43.67 132 4443 51927 1690279
Extravasation 121.00 43.67 32 4543 582 1741624
Diffuse large B-cell lymphoma 118.64 43.67 36 4539 1093 1741113
Cytopenia 116.42 43.67 34 4541 902 1741304
Basal cell carcinoma 115.99 43.67 43 4532 2440 1739766
Cytomegalovirus chorioretinitis 114.55 43.67 28 4547 365 1741841
Platelet count decreased 114.54 43.67 78 4497 16445 1725761
Rash maculo-papular 109.28 43.67 46 4529 3657 1738549
Hypotension 106.96 43.67 95 4480 29559 1712647
End stage renal disease 106.91 43.67 29 4546 583 1741623
Bacteraemia 104.40 43.67 37 4538 1843 1740363
Infusion site extravasation 101.32 43.67 27 4548 506 1741700
Bone marrow failure 100.37 43.67 48 4527 5152 1737054
Diarrhoea 95.62 43.67 118 4457 53734 1688472
Pleural effusion 95.38 43.67 60 4515 11050 1731156
Acute myeloid leukaemia 93.82 43.67 39 4536 3002 1739204
B-cell lymphoma 89.39 43.67 27 4548 806 1741400
Cytokine release syndrome 85.99 43.67 24 4551 538 1741668
Neuropathy peripheral 84.53 43.67 52 4523 9201 1733005
Pneumonitis 81.24 43.67 38 4537 3877 1738329
Blood pressure decreased 80.28 43.67 47 4528 7599 1734607
Lymphopenia 79.75 43.67 31 4544 2002 1740204
Phlebitis 79.60 43.67 24 4551 712 1741494
Drug ineffective 78.49 43.67 117 4458 63684 1678522
Mantle cell lymphoma 78.41 43.67 20 4555 313 1741893
Hodgkin's disease 78.07 43.67 24 4551 761 1741445
Herpes zoster 75.63 43.67 38 4537 4535 1737671
Hepatitis B reactivation 75.28 43.67 20 4555 370 1741836
Plasma cell myeloma 73.42 43.67 49 4526 9965 1732241
Mucosal inflammation 72.95 43.67 36 4539 4133 1738073
Asthenia 71.31 43.67 82 4493 34588 1707618
B-cell lymphoma recurrent 65.57 43.67 13 4562 57 1742149
Fatigue 65.04 43.67 95 4480 50686 1691520
Stevens-Johnson syndrome 64.78 43.67 31 4544 3326 1738880
Renal failure 63.95 43.67 60 4515 19957 1722249
Squamous cell carcinoma of skin 63.50 43.67 23 4552 1219 1740987
Respiratory failure 61.36 43.67 51 4524 14454 1727752
Nausea 60.15 43.67 92 4483 51104 1691102
Multiple organ dysfunction syndrome 60.09 43.67 42 4533 9200 1733006
Hypersensitivity 59.96 43.67 44 4531 10400 1731806
Device related infection 59.50 43.67 26 4549 2260 1739946
C-reactive protein increased 58.67 43.67 35 4540 5850 1736356
Dehydration 58.46 43.67 54 4521 17604 1724602
Haemolysis 57.60 43.67 21 4554 1134 1741072
Metastases to retroperitoneum 55.63 43.67 10 4565 22 1742184
Metastases to muscle 55.32 43.67 10 4565 23 1742183
Haemolytic anaemia 54.46 43.67 23 4552 1839 1740367
Interstitial lung disease 53.75 43.67 40 4535 9656 1732550
Blood lactate dehydrogenase increased 53.40 43.67 28 4547 3647 1738559
Cough 52.77 43.67 53 4522 19144 1723062
Syncope 52.13 43.67 46 4529 14123 1728083
Erythema 52.08 43.67 46 4529 14142 1728064
Second primary malignancy 51.86 43.67 19 4556 1040 1741166
Pneumocystis jirovecii infection 51.28 43.67 14 4561 288 1741918
Death 50.75 43.67 116 4459 87327 1654879
Metastases to bone marrow 50.18 43.67 11 4564 85 1742121
Colitis 50.02 43.67 28 4547 4152 1738054
Pulmonary embolism 49.25 43.67 43 4532 13016 1729190
Aplasia pure red cell 48.91 43.67 18 4557 998 1741208
Vasculitis 47.88 43.67 20 4555 1555 1740651
Pneumonia cytomegaloviral 47.71 43.67 14 4561 377 1741829
Metastases to spleen 46.61 43.67 10 4565 69 1742137
Vomiting 46.55 43.67 70 4505 38245 1703961
Hypoxia 45.66 43.67 30 4545 5933 1736273
Drug ineffective for unapproved indication 45.00 43.67 20 4555 1809 1740397
Dermatitis exfoliative 44.71 43.67 19 4556 1542 1740664
Bronchopulmonary aspergillosis 44.65 43.67 19 4556 1547 1740659
Pruritus 44.44 43.67 53 4522 23169 1719037
Lower respiratory tract infection 43.92 43.67 25 4550 3826 1738380
Mixed dementia 43.91 43.67 7 4568 4 1742202

Pharmacologic Action:

SourceCodeDescription
ATC L01AA09 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Nitrogen mustard analogues
FDA MoA N0000000236 Alkylating Activity
FDA EPC N0000175558 Alkylating Drug
MeSH PA D000477 Alkylating Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D009676 Noxae

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006
Follicular non-Hodgkin's lymphoma indication 308121000
Indolent B-Cell Lymphoma indication
Mantle cell lymphoma off-label use 443487006
Fluid volume disorder contraindication 1860003
Hyperkalemia contraindication 14140009
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Acute infectious disease contraindication 63171007
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Smokes tobacco daily contraindication 449868002
Chemotherapy-Induced Hyperuricemia contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.61 acidic
pKa2 6.18 Basic
pKa3 2.83 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER IV (INFUSION) 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
180MG/2ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION IV (INFUSION) 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER IV (INFUSION) 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
45MG/0.5ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION IV (INFUSION) 8791270 Jan. 12, 2026 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 8791270 Jan. 12, 2026 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 8791270 Jan. 12, 2026 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 8791270 Jan. 12, 2026 FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER IV (INFUSION) 8445524 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER IV (INFUSION) 8669279 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER IV (INFUSION) 8883836 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER IV (INFUSION) 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
100MG/VIAL TREANDA CEPHALON N022249 March 20, 2008 RX POWDER IV (INFUSION) 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER IV (INFUSION) 8445524 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER IV (INFUSION) 8669279 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER IV (INFUSION) 8883836 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER IV (INFUSION) 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
25MG/VIAL TREANDA CEPHALON N022249 May 1, 2009 RX POWDER IV (INFUSION) 9533955 March 26, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
180MG/2ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION IV (INFUSION) 8344006 Sept. 23, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
45MG/0.5ML (90MG/ML) TREANDA CEPHALON N022249 Sept. 13, 2013 DISCN SOLUTION IV (INFUSION) 8344006 Sept. 23, 2029 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9572796 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9572797 Jan. 28, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 8609707 Aug. 11, 2031 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BELRAPZO EAGLE PHARMS N205580 May 15, 2018 RX SOLUTION IV (INFUSION) 8609707 Aug. 11, 2031 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 8609707 Aug. 11, 2031 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 10052385 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 10052385 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9000021 March 15, 2033 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9034908 March 15, 2033 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9144568 March 15, 2033 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9572887 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9572887 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9579384 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9579384 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9597397 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9597397 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9597398 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9597399 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) 9597399 March 15, 2033 FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/4ML (25MG/ML) BENDEKA EAGLE PHARMS N208194 Dec. 7, 2015 RX SOLUTION IV (INFUSION) Dec. 7, 2022 TREATMENT OF PATIENTS WITH CLL AND TREATMENT OF PATIENTS WITH INDOLENT B-CELL NHL THAT HAS PROGRESSED DURING OR WITHIN SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histone deacetylase 3 Enzyme IC50 7.60 CHEMBL
Histone deacetylase 1 Enzyme IC50 7.77 CHEMBL
Histone deacetylase 2 Enzyme IC50 8.05 CHEMBL
Histone deacetylase 10 Enzyme IC50 7.14 CHEMBL
Histone deacetylase 8 Enzyme IC50 6.97 CHEMBL
Histone deacetylase 6 Enzyme IC50 8.22 CHEMBL
DNA DNA OTHER DRUG LABEL DRUG LABEL

External reference:

IDSource
D000069461 MESH_DESCRIPTOR_UI
4027339 VUID
N0000179513 NUI
C0525079 UMLSCUI
D07085 KEGG_DRUG
241056 MMSL
427812009 SNOMEDCT_US
428012008 SNOMEDCT_US
134547 RXNORM
d07121 MMSL
4027339 VANDF
006925 NDDF
9266D9P3PQ UNII
5228 INN_ID
3543-75-7 SECONDARY_CAS_RN
CHEMBL487253 ChEMBL_ID
DB06769 DRUGBANK_ID
CHEBI:135515 CHEBI
7478 IUPHAR_LIGAND_ID
CHEMBL1201734 ChEMBL_ID
65628 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BENDAMUSTINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 42367-520 INJECTION 100 mg INTRAVENOUS NDA 17 sections
BELRAPZO HUMAN PRESCRIPTION DRUG LABEL 1 42367-521 INJECTION 100 mg INTRAVENOUS NDA 17 sections
Bendeka HUMAN PRESCRIPTION DRUG LABEL 1 63459-348 INJECTION, SOLUTION 25 mg INTRAVENOUS NDA 17 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-390 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS NDA 17 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-391 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 17 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-395 INJECTION, SOLUTION, CONCENTRATE 45 mg INTRAVENOUS NDA 17 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-396 INJECTION, SOLUTION, CONCENTRATE 180 mg INTRAVENOUS NDA 17 sections