ulipristal 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| steroidal compounds acting on progesterone receptors | 4166 | 126784-99-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ulipristal acetate is a selective progesterone receptor modulator with antagonistic and partial agonistic effects (a progesterone agonist/antagonist) at the progesterone receptor. It binds the human progesterone receptor and prevents progesterone from occupying its receptor. The likely primary mechanism of action of ulipristal acetate for emergency contraception is inhibition or delay of ovulation.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 30 | mg | O |
| 5 | mg | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 15, 2009 | EMA | ||
| Aug. 13, 2010 | FDA | LAB HRA PHARMA |
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 |
|---|---|---|---|---|---|---|
| Unintended pregnancy | 245.69 | 42.66 | 44 | 604 | 6135 | 63482239 |
| Abortion spontaneous | 95.11 | 42.66 | 30 | 618 | 47165 | 63441209 |
| Vaginal haemorrhage | 65.92 | 42.66 | 20 | 628 | 27467 | 63460907 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Unintended pregnancy | 229.67 | 41.27 | 37 | 538 | 3896 | 79739917 |
| Abortion spontaneous | 99.75 | 41.27 | 26 | 549 | 29481 | 79714332 |
| Vaginal haemorrhage | 58.33 | 41.27 | 16 | 559 | 21801 | 79722012 |
| Uterine haemorrhage | 45.67 | 41.27 | 9 | 566 | 2894 | 79740919 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G03AD02 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Emergency contraceptives |
| ATC | G03XB02 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM Progesterone receptor modulators |
| MeSH PA | D003270 | Contraceptive Agents |
| MeSH PA | D003271 | Contraceptive Agents, Female |
| MeSH PA | D000080066 | Contraceptive Agents, Hormonal |
| MeSH PA | D012102 | Reproductive Control Agents |
| FDA MoA | N0000191262 | Selective Progesterone Receptor Modulators |
| FDA EPC | N0000191263 | Progesterone Agonist/Antagonist |
| CHEBI has role | CHEBI:49323 | contraceptive drugs |
| CHEBI has role | CHEBI:59826 | progestins |
| CHEBI has role | CHEBI:71027 | progesterone receptor modulators |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Uterine leiomyoma | indication | 95315005 | DOID:13223 |
| Postcoital contraception | indication | 268463003 | |
| Pregnancy, function | contraindication | 289908002 | |
| Breastfeeding (mother) | contraindication | 413712001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.7 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 30MG | ELLA | LAB HRA PHARMA | N022474 | Aug. 13, 2010 | RX | TABLET | ORAL | 10159681 | April 13, 2030 | A METHOD FOR CONTRACEPTION COMPRISING THE STEP OF ORAL ADMINISTRATION A DOSAGE OF 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE |
| 30MG | ELLA | LAB HRA PHARMA | N022474 | Aug. 13, 2010 | RX | TABLET | ORAL | 10772897 | April 13, 2030 | A METHOD FOR CONTRACEPTION, THE METHOD COMPRISING ADMINISTERING A TABLET COMPRISING 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 120 HOURS AFTER AN UNPROTECTED INTERCOURSE |
| 30MG | ELLA | LAB HRA PHARMA | N022474 | Aug. 13, 2010 | RX | TABLET | ORAL | 9283233 | April 13, 2030 | METHOD FOR CONTRACEPTION TO A WOMAN COMPRISING ADMINISTERING TO THE WOMAN 30MG OF ULIPRISTAL ACETATE MORE THAN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE |
| 30MG | ELLA | LAB HRA PHARMA | N022474 | Aug. 13, 2010 | RX | TABLET | ORAL | 8426392 | June 12, 2030 | ELLA IS A PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD |
| 30MG | ELLA | LAB HRA PHARMA | N022474 | Aug. 13, 2010 | RX | TABLET | ORAL | 8962603 | June 12, 2030 | METHOD FOR PROVIDING POST COITAL CONTRACEPTION TO A WOMAN BY ADMINISTERING ABOUT 30 MG OF ULIPRISTAL ACETATE WITHIN ABOUT 120 HOURS AFTER INTERCOURSE, WHEREIN THE WOMAN IS OVERWEIGHT HAVING A BMI OF 25 TO 29.99 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 30MG | ELLA | LAB HRA PHARMA | N022474 | Aug. 13, 2010 | RX | TABLET | ORAL | June 24, 2024 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDYHRA2914-5016 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Progesterone receptor | Nuclear hormone receptor | ANTAGONIST | IC50 | 9.70 | IUPHAR | IUPHAR |
External reference:
| ID | Source |
|---|---|
| 4030133 | VUID |
| N0000181720 | NUI |
| D09567 | KEGG_DRUG |
| 159811-51-5 | SECONDARY_CAS_RN |
| 4030133 | VANDF |
| 4030140 | VANDF |
| CHEBI:71025 | CHEBI |
| 2S0 | PDB_CHEM_ID |
| CHEMBL2103846 | ChEMBL_ID |
| CHEMBL260538 | ChEMBL_ID |
| C094854 | MESH_SUPPLEMENTAL_RECORD_UI |
| C555622 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7460 | IUPHAR_LIGAND_ID |
| 8367 | INN_ID |
| DB08867 | DRUGBANK_ID |
| 6J5J15Q2X8 | UNII |
| 1005920 | RXNORM |
| 175839 | MMSL |
| 26777 | MMSL |
| d07495 | MMSL |
| 013245 | NDDF |
| 013246 | NDDF |
| 703249005 | SNOMEDCT_US |
| 703250005 | SNOMEDCT_US |
| 703737005 | SNOMEDCT_US |
| C0300205 | UMLSCUI |
| 13559281 | PUBCHEM_CID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-2835 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-5422 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-5422 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50102-911 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53002-1630 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53002-2630 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67296-1466 | TABLET | 30 mg | ORAL | NDA | 28 sections |
| Ella | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73302-456 | TABLET | 30 mg | ORAL | NDA | 28 sections |