bendamustine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives | 302 | 16506-27-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 20, 2008 | FDA | CEPHALON |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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:
| Source | Code | Description |
|---|---|---|
| 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)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.61 | acidic |
| pKa2 | 6.18 | Basic |
| pKa3 | 2.83 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |