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

Stem definitionDrug idCAS RN
ergot alkaloid derivatives 403 25614-03-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bromocriptine
  • bromocriptin
  • bromocryptine
  • ergolactin
  • 2-bromoergocriptine
  • bromocriptine mesylate
  • bromocriptine mesilate
A semisynthetic ergotamine alkaloid that is a dopamine D2 agonist. It suppresses prolactin secretion.
  • Molecular weight: 654.61
  • Formula: C32H40BrN5O5
  • CLOGP: 6.58
  • LIPINSKI: 2
  • HAC: 10
  • HDO: 3
  • TPSA: 118.21
  • ALOGS: -3.88
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
5 mg O
5 mg P
40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.19 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 28 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
June 28, 1978 FDA US PHARMS HOLDINGS I

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
Exposure during pregnancy 112.85 38.12 35 335 25184 2332531
Neuroleptic malignant syndrome 96.40 38.12 19 351 2061 2355654
Maternal exposure during pregnancy 93.93 38.12 27 343 14836 2342879
Headache 89.32 38.12 40 330 80139 2277576
Blood prolactin increased 69.59 38.12 13 357 1054 2356661
Gambling disorder 57.73 38.12 9 361 245 2357470
Visual pathway disorder 56.60 38.12 7 363 30 2357685
Nausea 54.18 38.12 32 338 112157 2245558
Compulsive shopping 53.62 38.12 8 362 161 2357554
Mediastinal fibrosis 51.90 38.12 6 364 12 2357703
Caesarean section 47.23 38.12 12 358 4069 2353646
Hypersexuality 46.95 38.12 7 363 140 2357575
Vomiting 44.02 38.12 24 346 71578 2286137
Normal newborn 43.05 38.12 9 361 1291 2356424
Mitral valve incompetence 42.19 38.12 10 360 2540 2355175
Pituitary tumour removal 41.57 38.12 5 365 16 2357699
Psychomotor hyperactivity 39.55 38.12 9 361 1913 2355802

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
Gambling disorder 125.37 57.79 19 231 391 1746140
Serotonin syndrome 100.55 57.79 21 229 2767 1743764
Stress cardiomyopathy 82.34 57.79 13 237 348 1746183
Impulse-control disorder 75.91 57.79 12 238 323 1746208
Neuroleptic malignant syndrome 64.79 57.79 15 235 3133 1743398

Pharmacologic Action:

SourceCodeDescription
ATC G02CB01 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Prolactine inhibitors
ATC N04BC01 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Dopamine agonists
FDA Chemical/Ingredient N0000007618 Ergolines
FDA EPC N0000175827 Ergot Derivative
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018491 Dopamine Agonists
MeSH PA D006727 Hormone Antagonists
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:49020 hormone antagonist
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:66956 antidyskinesia agent
CHEBI has role CHEBI:51065 dopamine agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postencephalitic parkinsonism indication 19972008 DOID:14332
Parkinson's disease indication 49049000 DOID:14330
Acromegaly indication 74107003 DOID:2449
Hyperprolactinemia indication 237662005 DOID:12700
Type 2 Diabetes Mellitus Treatment Adjunct indication
Neuroleptic malignant syndrome off-label use 15244003 DOID:14464
Hypertensive disorder contraindication 38341003 DOID:10763
Mild pre-eclampsia contraindication 41114007
Severe pre-eclampsia contraindication 46764007
Pregnancy-induced hypertension contraindication 48194001
Eclampsia in pregnancy contraindication 198992004
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Hypertensive urgency contraindication 443482000
Psychiatric Disturbance contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.98 acidic
pKa2 12.93 acidic
pKa3 5.98 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 7888310 July 25, 2023 IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 8137992 July 25, 2023 IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 8137993 July 25, 2023 IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 8137994 July 25, 2023 IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 8877708 June 7, 2030 TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE WHEREIN THE COMBINED THERAPEUTIC EFFECT IS GREATER THAN THE ADDITIVE EFFECT OF ADMINISTERING EACH AGENT ALONE
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 10 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 10
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 12 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 12
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 19 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 19
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 6 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 6
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 7 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 7
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 9 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 9
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 1-5 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 1-5
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO TREAT GLUCOSE INTOLERANCE IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 14-15 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 14-15
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9352025 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO TREAT GLUCOSE INTOLERANCE IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 16-18 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 16-18
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 11 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 11
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 12 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 12
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 14 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 14
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 1 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 1
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 8 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 8
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 9 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 9
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 16-19 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 16-19
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 3-7 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 3-7
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9895422 June 7, 2030 ADJUNCT TO DIET AND EXERCISE TO TREAT GLUCOSE INTOLERANCE IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 2 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 2
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 8431155 April 30, 2032 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 8613947 April 30, 2032 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9192576 April 30, 2032 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9522117 April 30, 2032 ADMINISTRATION ONCE DAILY WITHIN TWO HOURS AFTER WAKING IN THE MORNING FOR IMPROVEMENT OF GLYCEMIC CONTROL IN A TYPE 2 DIABETES PATIENT
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9522117 April 30, 2032 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXECRISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 29, 39, AND 40
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING MICRONIZED BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 15, 27, AND 28
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING MICRONIZED BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 15 AND 27
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING MICRONIZED BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 66, 75, AND 76
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING MICRONIZED BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 66 AND 75
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1, 13, AND 14
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1 AND 13
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 29 AND 39
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 41, 52, AND 53
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 41 AND 52
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 54, 64, AND 65
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 54 AND 64
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 77, 87, AND 88
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 77 AND 87
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 89, 99, AND 100
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9700555 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 89 AND 99
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXCERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 30, 41, AND 42
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 12, 19 AND 20
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 12 AND 19
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 21, 28, AND 29
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 21 AND 28
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 30 AND 41
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 43, 50 AND 51
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 43 AND 50
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING MICRONIZED BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1,10 AND 11
EQ 0.8MG BASE CYCLOSET VEROSCIENCE N020866 May 5, 2009 RX TABLET ORAL 9993474 April 30, 2032 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING A DOSAGE FORM COMPRISING MICRONIZED BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1 AND 10

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR AGONIST Ki 9.70 WOMBAT-PK CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 8.86 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 8 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.30 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR AGONIST Ki 7.50 IUPHAR
D(4) dopamine receptor GPCR ANTAGONIST Ki 6.40 IUPHAR
D(1B) dopamine receptor GPCR AGONIST Ki 6.30 IUPHAR
D(1A) dopamine receptor GPCR AGONIST Ki 6.20 IUPHAR
Beta-1 adrenergic receptor GPCR Ki 5.86 DRUG MATRIX
Cytochrome P450 3A4 Enzyme IC50 5.70 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR Ki 8.55 DRUG MATRIX
D(3) dopamine receptor GPCR AGONIST Ki 7.50 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR Ki 8.38 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Ki 7.90 WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 8 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 7.60 WOMBAT-PK
5-hydroxytryptamine receptor 1B GPCR Ki 6.50 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 7.50 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR Ki 6.10 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 7 WOMBAT-PK
Beta-2 adrenergic receptor GPCR Ki 6.13 PDSP
Androgen receptor Transcription factor Ki 5.82 DRUG MATRIX
Alpha-1B adrenergic receptor GPCR Ki 8.71 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 7.33 DRUG MATRIX
Dopamine receptor GPCR IC50 7.55 CHEMBL
Adrenergic receptor alpha-2 GPCR IC50 6.29 CHEMBL
Cerebral cortex alpha adrenergic receptor GPCR IC50 6.29 CHEMBL
D(2) dopamine receptor GPCR Kd 8.40 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 8.25 CHEMBL
Alpha-1A adrenergic receptor GPCR IC50 8.16 CHEMBL
Vesicular glutamate transporter 3 Unclassified IC50 4.66 CHEMBL
5-hydroxytryptamine receptor 7 GPCR AGONIST Ki 8 IUPHAR
5-hydroxytryptamine receptor 6 GPCR AGONIST Ki 7.50 IUPHAR

External reference:

IDSource
D001971 MESH_DESCRIPTOR_UI
4019639 VUID
N0000147732 NUI
C0006230 UMLSCUI
D00780 KEGG_DRUG
3A64E3G5ZO UNII
3365 INN_ID
387039007 SNOMEDCT_US
116656002 SNOMEDCT_US
4019639 VANDF
1760 RXNORM
d00178 MMSL
002117 NDDF
CHEMBL493 ChEMBL_ID
CHEMBL311816 ChEMBL_ID
CHEMBL1200503 ChEMBL_ID
22260-51-1 SECONDARY_CAS_RN
08Y PDB_CHEM_ID
DB01200 DRUGBANK_ID
CHEBI:3181 CHEBI
35 IUPHAR_LIGAND_ID
31101 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bromocriptine Mesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-2042 TABLET 2.50 mg ORAL ANDA 11 sections
Bromocriptine Mesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-7096 CAPSULE 5 mg ORAL ANDA 11 sections
Bromocriptine mesylate HUMAN PRESCRIPTION DRUG LABEL 1 0574-0106 TABLET 2.50 mg ORAL ANDA 12 sections
Bromocriptine mesylate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5325 TABLET 2.50 mg ORAL ANDA 11 sections
Parlodel HUMAN PRESCRIPTION DRUG LABEL 1 30698-201 CAPSULE, GELATIN COATED 5 mg ORAL NDA 11 sections
Parlodel HUMAN PRESCRIPTION DRUG LABEL 1 30698-202 TABLET 2.50 mg ORAL NDA 11 sections
Bromocriptine Mesylate HUMAN PRESCRIPTION DRUG LABEL 1 54868-5667 TABLET 2.50 mg ORAL ANDA 11 sections
Bromocriptine Mesylate HUMAN PRESCRIPTION DRUG LABEL 1 60687-286 TABLET 2.50 mg ORAL ANDA 11 sections
BROMOCRIPTINE MESYLATE HUMAN PRESCRIPTION DRUG LABEL 1 63304-158 CAPSULE 5 mg ORAL NDA 11 sections
BROMOCRIPTINE MESYLATE HUMAN PRESCRIPTION DRUG LABEL 1 63304-962 TABLET 2.50 mg ORAL NDA 11 sections
Bromocriptine mesylate HUMAN PRESCRIPTION DRUG LABEL 1 65841-654 CAPSULE 5 mg ORAL ANDA 1 sections
CYCLOSET HUMAN PRESCRIPTION DRUG LABEL 1 68012-258 TABLET 0.80 mg ORAL NDA 18 sections
Bromocriptine mesylate HUMAN PRESCRIPTION DRUG LABEL 1 68151-1305 TABLET 2.50 mg ORAL ANDA 12 sections
Bromocriptine mesylate HUMAN PRESCRIPTION DRUG LABEL 1 68382-110 CAPSULE 5 mg ORAL ANDA 13 sections
CYCLOSET HUMAN PRESCRIPTION DRUG LABEL 1 73515-123 TABLET 0.80 mg ORAL NDA 18 sections