serdexmethylphenidate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5448 | 1996626-30-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Serdexmethylphenidate is a prodrug of dexmethylphenidate (d-MPH). The mode of therapeutic action in ADHD is not known. Serdexmethylphenidate is not deemed to have pharmacological activity until converted to d-MPH. Dexmethylphenidate HCl is a central nervous system (CNS) stimulant that blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 2, 2021 | FDA | COMMCAVE THERAPEUTICS SA |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06BA15 | NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D000697 | Central Nervous System Stimulants |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Attention deficit hyperactivity disorder | indication | 406506008 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 10.4MG BASE;EQ 52.3MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10858341 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 10.4MG BASE;EQ 52.3MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10954213 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 5.2MG BASE;EQ 26.1MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10858341 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 5.2MG BASE;EQ 26.1MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10954213 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 7.8MG BASE;EQ 39.2MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10858341 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 7.8MG BASE;EQ 39.2MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10954213 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10.4MG BASE;EQ 52.3MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | May 7, 2026 | NEW CHEMICAL ENTITY |
| EQ 5.2MG BASE;EQ 26.1MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | May 7, 2026 | NEW CHEMICAL ENTITY |
| EQ 7.8MG BASE;EQ 39.2MG BASE | AZSTARYS | COMMAVE THERAP | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | May 7, 2026 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D11401 | KEGG_DRUG |
| 0H8KZ470DW | UNII |
| C5237972 | UMLSCUI |
| CHEMBL4301162 | ChEMBL_ID |
| 134823895 | PUBCHEM_CID |
| DB16629 | DRUGBANK_ID |
| CHEMBL4298139 | ChEMBL_ID |
| C000718174 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11450 | IUPHAR_LIGAND_ID |
| 018662 | NDDF |
| 018663 | NDDF |
| 1179218001 | SNOMEDCT_US |
| 1179219009 | SNOMEDCT_US |
| 4040657 | VANDF |
| 1996626-29-9 | SECONDARY_CAS_RN |
| 2562176 | RXNORM |
| 344090 | MMSL |
| 39359 | MMSL |
| d09719 | MMSL |
| 10916 | INN_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-286 | CAPSULE | 26.10 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-286 | CAPSULE | 26.10 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-286 | CAPSULE | 26.10 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-429 | CAPSULE | 39.20 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-429 | CAPSULE | 39.20 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-429 | CAPSULE | 39.20 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-561 | CAPSULE | 52.30 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-561 | CAPSULE | 52.30 mg | ORAL | NDA | 31 sections |
| AZSTARYS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 65038-561 | CAPSULE | 52.30 mg | ORAL | NDA | 31 sections |