apomorphine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 228 | 58-00-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A derivative of morphine that is a dopamine D2 agonist. It is a powerful emetic and has been used for that effect in acute poisoning. It has also been used in the diagnosis and treatment of parkinsonism, but its adverse effects limit its use.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | mg | SL |
| 20 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 20 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.30 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.32 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 10 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.60 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 40 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) | 0.68 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 20, 2004 | FDA | US WORLDMEDS |
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 |
|---|---|---|---|---|---|---|
| Blood pressure decreased | 165.53 | 36.01 | 71 | 2347 | 55838 | 50546868 |
| Somnolence | 164.24 | 36.01 | 98 | 2320 | 154887 | 50447819 |
| Nausea | 159.84 | 36.01 | 180 | 2238 | 705218 | 49897488 |
| Yawning | 102.25 | 36.01 | 20 | 2398 | 913 | 50601793 |
| Dizziness | 92.44 | 36.01 | 97 | 2321 | 346272 | 50256434 |
| Injection site nodule | 72 | 36.01 | 19 | 2399 | 3329 | 50599377 |
| Dyskinesia | 71.28 | 36.01 | 32 | 2386 | 27829 | 50574877 |
| Product taste abnormal | 68.25 | 36.01 | 16 | 2402 | 1729 | 50600977 |
| On and off phenomenon | 60.80 | 36.01 | 14 | 2404 | 1398 | 50601308 |
| Hyperkinesia | 60.41 | 36.01 | 14 | 2404 | 1438 | 50601268 |
| Freezing phenomenon | 59.77 | 36.01 | 13 | 2405 | 1002 | 50601704 |
| Injection site necrosis | 57.25 | 36.01 | 13 | 2405 | 1220 | 50601486 |
| Product packaging difficult to open | 55.76 | 36.01 | 8 | 2410 | 50 | 50602656 |
| Feeling abnormal | 52.01 | 36.01 | 45 | 2373 | 125447 | 50477259 |
| Vomiting | 47.27 | 36.01 | 81 | 2337 | 460677 | 50142029 |
| Dysgeusia | 47.23 | 36.01 | 27 | 2391 | 38889 | 50563817 |
| Hallucination | 45.22 | 36.01 | 28 | 2390 | 46629 | 50556077 |
| Blood pressure increased | 43.90 | 36.01 | 42 | 2376 | 133090 | 50469616 |
| Orthostatic hypotension | 37.23 | 36.01 | 21 | 2397 | 29460 | 50573246 |
| Hyperhidrosis | 36.86 | 36.01 | 32 | 2386 | 89394 | 50513312 |
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 |
|---|---|---|---|---|---|---|
| Somnolence | 275.53 | 34.93 | 163 | 3658 | 93792 | 29476914 |
| Dizziness | 216.91 | 34.93 | 185 | 3636 | 189499 | 29381207 |
| Yawning | 198.96 | 34.93 | 37 | 3784 | 453 | 29570253 |
| Blood pressure decreased | 193.35 | 34.93 | 101 | 3720 | 45376 | 29525330 |
| Nausea | 181.59 | 34.93 | 203 | 3618 | 289052 | 29281654 |
| On and off phenomenon | 114.10 | 34.93 | 30 | 3791 | 1898 | 29568808 |
| Orthostatic hypotension | 109.68 | 34.93 | 55 | 3766 | 22574 | 29548132 |
| Hyperhidrosis | 94.27 | 34.93 | 73 | 3748 | 64467 | 29506239 |
| Dyskinesia | 83.42 | 34.93 | 44 | 3777 | 20017 | 29550689 |
| Hallucination | 77.31 | 34.93 | 56 | 3765 | 44656 | 29526050 |
| Feeling abnormal | 71.74 | 34.93 | 58 | 3763 | 54387 | 29516319 |
| Hallucination, visual | 65.44 | 34.93 | 34 | 3787 | 14981 | 29555725 |
| Freezing phenomenon | 62.18 | 34.93 | 17 | 3804 | 1246 | 29569460 |
| Injection site necrosis | 59.63 | 34.93 | 13 | 3808 | 366 | 29570340 |
| Oral discomfort | 55.51 | 34.93 | 18 | 3803 | 2375 | 29568331 |
| Fall | 45.98 | 34.93 | 82 | 3739 | 177096 | 29393610 |
| Oesophageal achalasia | 44.57 | 34.93 | 10 | 3811 | 322 | 29570384 |
| Dysstasia | 43.57 | 34.93 | 23 | 3798 | 10451 | 29560255 |
| Injection site nodule | 42.15 | 34.93 | 13 | 3808 | 1457 | 29569249 |
| Illusion | 41.89 | 34.93 | 11 | 3810 | 691 | 29570015 |
| Blood pressure increased | 40.95 | 34.93 | 49 | 3772 | 73754 | 29496952 |
| Nodule | 38.91 | 34.93 | 17 | 3804 | 5095 | 29565611 |
| Pallor | 37.80 | 34.93 | 27 | 3794 | 20997 | 29549709 |
| Heart rate decreased | 35.87 | 34.93 | 28 | 3793 | 24884 | 29545822 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Somnolence | 337.49 | 33.96 | 204 | 4794 | 203441 | 64290293 |
| Blood pressure decreased | 297.51 | 33.96 | 141 | 4857 | 86058 | 64407676 |
| Nausea | 248.48 | 33.96 | 302 | 4696 | 785498 | 63708236 |
| Yawning | 232.89 | 33.96 | 45 | 4953 | 1171 | 64492563 |
| Dizziness | 224.38 | 33.96 | 216 | 4782 | 429947 | 64063787 |
| On and off phenomenon | 173.26 | 33.96 | 40 | 4958 | 2479 | 64491255 |
| Orthostatic hypotension | 120.92 | 33.96 | 63 | 4935 | 46675 | 64447059 |
| Freezing phenomenon | 103.38 | 33.96 | 24 | 4974 | 1522 | 64492212 |
| Hallucination | 97.44 | 33.96 | 64 | 4934 | 72724 | 64421010 |
| Dyskinesia | 95.90 | 33.96 | 51 | 4947 | 39337 | 64454397 |
| Hyperhidrosis | 88.67 | 33.96 | 75 | 4923 | 124845 | 64368889 |
| Hallucination, visual | 88.00 | 33.96 | 43 | 4955 | 27791 | 64465943 |
| Injection site necrosis | 75.13 | 33.96 | 18 | 4980 | 1307 | 64492427 |
| Feeling abnormal | 74.50 | 33.96 | 70 | 4928 | 133532 | 64360202 |
| Product taste abnormal | 72.53 | 33.96 | 19 | 4979 | 1984 | 64491750 |
| Injection site nodule | 67.91 | 33.96 | 20 | 4978 | 3210 | 64490524 |
| Product packaging difficult to open | 63.48 | 33.96 | 9 | 4989 | 28 | 64493706 |
| Hyperkinesia | 63.47 | 33.96 | 18 | 4980 | 2528 | 64491206 |
| Dysstasia | 59.14 | 33.96 | 31 | 4967 | 23184 | 64470550 |
| Blood pressure increased | 53.02 | 33.96 | 66 | 4932 | 172486 | 64321248 |
| Oral discomfort | 52.63 | 33.96 | 21 | 4977 | 8385 | 64485349 |
| Dopamine dysregulation syndrome | 51.66 | 33.96 | 11 | 4987 | 468 | 64493266 |
| Feeling hot | 48.85 | 33.96 | 35 | 4963 | 45628 | 64448106 |
| Dysgeusia | 47.91 | 33.96 | 35 | 4963 | 47012 | 64446722 |
| Heart rate decreased | 47.29 | 33.96 | 37 | 4961 | 55030 | 64438704 |
| Cold sweat | 44.85 | 33.96 | 23 | 4975 | 16432 | 64477302 |
| Oesophageal achalasia | 42.38 | 33.96 | 10 | 4988 | 680 | 64493054 |
| Vomiting | 39.18 | 33.96 | 112 | 4886 | 551005 | 63942729 |
| Illusion | 38.68 | 33.96 | 11 | 4987 | 1559 | 64492175 |
| Infusion site necrosis | 38.08 | 33.96 | 6 | 4992 | 44 | 64493690 |
| Soft tissue mass | 34.73 | 33.96 | 9 | 4989 | 900 | 64492834 |
| Impulse-control disorder | 34.11 | 33.96 | 10 | 4988 | 1578 | 64492156 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G04BE07 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs used in erectile dysfunction |
| ATC | N04BC07 | NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopamine agonists |
| FDA MoA | N0000000117 | Dopamine Agonists |
| FDA EPC | N0000175580 | Dopaminergic Agonist |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D015259 | Dopamine Agents |
| MeSH PA | D018491 | Dopamine Agonists |
| MeSH PA | D004639 | Emetics |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| CHEBI has role | CHEBI:48278 | serotonergic drugs |
| CHEBI has role | CHEBI:48407 | antiparkinson agent |
| CHEBI has role | CHEBI:48539 | alpha-adrenergic drugs |
| CHEBI has role | CHEBI:51065 | Dopamine receptor agonist |
| CHEBI has role | CHEBI:66956 | antidyskinetic agent |
| CHEBI has role | CHEBI:149552 | emetics |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Parkinson's disease | indication | 49049000 | DOID:14330 |
| Priapism | contraindication | 6273006 | DOID:9286 |
| Alcoholism | contraindication | 7200002 | |
| Dyskinesia | contraindication | 9748009 | |
| Acute vomiting | contraindication | 23971007 | |
| Alcohol intoxication | contraindication | 25702006 | |
| Orthostatic hypotension | contraindication | 28651003 | |
| Torsades de pointes | contraindication | 31722008 | |
| Hypokalemia | contraindication | 43339004 | |
| Acute nephropathy | contraindication | 58574008 | |
| Cerebrovascular disease | contraindication | 62914000 | DOID:6713 |
| Psychotic disorder | contraindication | 69322001 | |
| Prolonged QT interval | contraindication | 111975006 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Impaired renal function disorder | contraindication | 197663003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Drowsy | contraindication | 271782001 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Congenital long QT syndrome | contraindication | 442917000 | |
| Progressive Angina Pectoris | contraindication | ||
| Severe Nausea | contraindication | ||
| Predisposition to Nausea and Vomiting | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.88 | acidic |
| pKa2 | 12.98 | acidic |
| pKa3 | 8.36 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10420763 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9283219 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9326981 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669019 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669021 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10420763 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9283219 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9326981 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669019 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669021 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10420763 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9283219 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9326981 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669019 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669021 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10420763 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9283219 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9326981 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669019 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669021 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10420763 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9283219 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9326981 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669019 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 9669021 | June 11, 2030 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8414922 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8846074 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8414922 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8846074 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8414922 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8846074 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8414922 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8846074 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8414922 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 8846074 | Dec. 16, 2031 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10449146 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10959943 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10449146 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10959943 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10449146 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10959943 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10449146 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10959943 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10449146 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | 10959943 | April 19, 2036 | TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSONS DISEASE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 30MG/3ML (10MG/ML) | APOMORPHINE HYDROCHLORIDE | SAGE CHEMS | A212025 | Feb. 23, 2022 | RX | INJECTABLE | SUBCUTANEOUS | Aug. 24, 2022 | COMPETITIVE GENERIC THERAPY |
| 10MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | May 21, 2023 | NEW PRODUCT |
| 15MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | May 21, 2023 | NEW PRODUCT |
| 20MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | May 21, 2023 | NEW PRODUCT |
| 25MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | May 21, 2023 | NEW PRODUCT |
| 30MG | KYNMOBI | SUNOVION PHARMS INC | N210875 | May 21, 2020 | RX | FILM | SUBLINGUAL | May 21, 2023 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| D(2) dopamine receptor | GPCR | AGONIST | Ki | 9.21 | CHEMBL | CHEMBL | |||
| Alpha-2A adrenergic receptor | GPCR | AGONIST | Ki | 6.90 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 6.53 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 2A | GPCR | ANTAGONIST | Ki | 6.90 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 2B | GPCR | ANTAGONIST | Ki | 6.90 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 2C | GPCR | ANTAGONIST | Ki | 7 | IUPHAR | ||||
| Alpha-1A adrenergic receptor | GPCR | Ki | 5.70 | PDSP | |||||
| Alpha-2B adrenergic receptor | GPCR | ANTAGONIST | Ki | 7.20 | IUPHAR | ||||
| D(3) dopamine receptor | GPCR | AGONIST | Ki | 8.59 | CHEMBL | ||||
| D(1B) dopamine receptor | GPCR | AGONIST | Ki | 7.80 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 1B | GPCR | Ki | 5.53 | PDSP | |||||
| 5-hydroxytryptamine receptor 1D | GPCR | Ki | 5.91 | PDSP | |||||
| Alpha-2C adrenergic receptor | GPCR | ANTAGONIST | Ki | 7.40 | IUPHAR | ||||
| D(4) dopamine receptor | GPCR | AGONIST | Ki | 8.05 | CHEMBL | ||||
| Alpha-1D adrenergic receptor | GPCR | Ki | 7.19 | WOMBAT-PK | |||||
| Alpha-1B adrenergic receptor | GPCR | Ki | 6.17 | PDSP | |||||
| Solute carrier family 22 member 1 | Transporter | IC50 | 4.68 | CHEMBL | |||||
| Transient receptor potential cation channel subfamily A member 1 | Ion channel | ACTIVATOR | EC50 | 5.10 | IUPHAR | ||||
| Mannose-6-phosphate isomerase | Enzyme | IC50 | 4.84 | CHEMBL | |||||
| D(1A) dopamine receptor | GPCR | Ki | 8.34 | CHEMBL | |||||
| E3 ubiquitin-protein ligase Mdm2 | Nuclear other | IC50 | 6.71 | CHEMBL | |||||
| D(2) dopamine receptor | GPCR | Ki | 8.74 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 6.53 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 7 | GPCR | Ki | 6.73 | CHEMBL | |||||
| D(1A) dopamine receptor | GPCR | Ki | 7.28 | CHEMBL | |||||
| D(2) dopamine receptor | GPCR | Ki | 6.70 | CHEMBL | |||||
| D(3) dopamine receptor | GPCR | Ki | 7.44 | CHEMBL | |||||
| D(4) dopamine receptor | GPCR | EC50 | 8.82 | CHEMBL | |||||
| D(1A) dopamine receptor | GPCR | Ki | 7 | CHEMBL | |||||
| Zinc finger protein mex-5 | Cytosolic other | EC50 | 5.35 | CHEMBL | |||||
| Opioid receptor | GPCR | IC50 | 6.52 | CHEMBL | |||||
| Serotonin (5-HT) receptor | GPCR | IC50 | 5.35 | CHEMBL | |||||
| Adrenergic receptor alpha-2 | GPCR | IC50 | 7.20 | CHEMBL | |||||
| Dopamine receptor | GPCR | IC50 | 9 | CHEMBL | |||||
| Dopamine receptor | GPCR | IC50 | 9 | CHEMBL | |||||
| Adrenergic receptor alpha-1 | GPCR | IC50 | 5.11 | CHEMBL | |||||
| Cytoplasmic zinc-finger protein | Unclassified | EC50 | 4.77 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019618 | VUID |
| N0000147712 | NUI |
| D02004 | KEGG_DRUG |
| 41372-20-7 | SECONDARY_CAS_RN |
| 1043 | RXNORM |
| C0003596 | UMLSCUI |
| CHEBI:48538 | CHEBI |
| 5RL | PDB_CHEM_ID |
| CHEMBL53 | ChEMBL_ID |
| DB00714 | DRUGBANK_ID |
| CHEMBL1616 | ChEMBL_ID |
| D001058 | MESH_DESCRIPTOR_UI |
| 6005 | PUBCHEM_CID |
| 33 | IUPHAR_LIGAND_ID |
| N21FAR7B4S | UNII |
| 17790 | MMSL |
| 71829 | MMSL |
| d04991 | MMSL |
| 001665 | NDDF |
| 004677 | NDDF |
| 4017524 | VANDF |
| 4019618 | VANDF |
| CHEMBL1256708 | ChEMBL_ID |
| 387375001 | SNOMEDCT_US |
| 67939000 | SNOMEDCT_US |
| 725667002 | SNOMEDCT_US |
| 74950007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| APOKYN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27505-004 | INJECTION | 30 mg | SUBCUTANEOUS | NDA | 33 sections |
| APOKYN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27505-004 | INJECTION | 30 mg | SUBCUTANEOUS | NDA | 33 sections |
| apomorphine hydrocloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52817-720 | INJECTION | 30 mg | SUBCUTANEOUS | ANDA | 33 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-010 | FILM, SOLUBLE | 10 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-010 | FILM, SOLUBLE | 10 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-015 | FILM, SOLUBLE | 15 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-015 | FILM, SOLUBLE | 15 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-020 | FILM, SOLUBLE | 20 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-020 | FILM, SOLUBLE | 20 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-025 | FILM, SOLUBLE | 25 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-025 | FILM, SOLUBLE | 25 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-030 | FILM, SOLUBLE | 30 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-030 | FILM, SOLUBLE | 30 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-110 | FILM, SOLUBLE | 10 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-110 | FILM, SOLUBLE | 10 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-115 | FILM, SOLUBLE | 15 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-115 | FILM, SOLUBLE | 15 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-120 | FILM, SOLUBLE | 20 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-120 | FILM, SOLUBLE | 20 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-125 | FILM, SOLUBLE | 25 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-125 | FILM, SOLUBLE | 25 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-130 | FILM, SOLUBLE | 30 mg | SUBLINGUAL | NDA | 34 sections |
| KYNMOBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-130 | FILM, SOLUBLE | 30 mg | SUBLINGUAL | NDA | 34 sections |