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Rolapitant hydrochloride - Generic Drug Details
What are the generic drug sources for rolapitant hydrochloride and what is the scope of rolapitant hydrochloride freedom to operate?
Rolapitant hydrochloride
is the generic ingredient in one branded drug marketed by Tersera Theraps Llc and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Rolapitant hydrochloride has one hundred and fifty-three patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for rolapitant hydrochloride
International Patents: | 153 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 40 |
Clinical Trials: | 12 |
Patent Applications: | 42 |
DailyMed Link: | rolapitant hydrochloride at DailyMed |
Pharmacology for rolapitant hydrochloride
Drug Class | Substance P/Neurokinin-1 Receptor Antagonist |
Mechanism of Action | Neurokinin 1 Antagonists Cytochrome P450 2D6 Inhibitors Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors |
Synonyms for rolapitant hydrochloride
(5S,8S)-8-(((1R)-1-(3,5-bis(Trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4.5)decan-2-one monohydrochloride monohydrate |
(5S,8S)-8-(((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one |
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-2-oxo-8-phenyl-1,7-diazaspiro[4.5]decan-7-ium chloride |
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-2-oxo-8-phenyl-1,7-diazaspiro[4.5]decan-7-ium chloride--water (1/1) |
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one |
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one hydrochloride |
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one hydrochloride--water (1/1) |
(5S,8S)-8-[[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one |
1-Methyl-4-[3-(5-nitro-2-furanyl)-1-oxo-2-propenyl]-piperazine |
1,7-Diazaspiro(4.5)decan-2-one, 8-(((1R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-, monohydrochloride, (5S,8S)- |
1,7-Diazaspiro(4.5)decan-2-one, 8-(((1R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-, monohydrochloride, monohydrate, (5S,8S)- |
552292-08-7 |
57O5S1QSAQ |
858102-79-1 |
914462-92-3 |
943029-75-2 |
AKOS027250926 |
AKOS030234023 |
API0014111 |
B5910 |
BC600524 |
bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one |
CHEBI:90908 |
CHEBI:90911 |
CHEBI:90912 |
CHEMBL3707330 |
CHEMBL3707331 |
CS-6387 |
D08988 |
D0CF0Y |
D10742 |
DB09291 |
DTXSID40235091 |
DTXSID70238570 |
DTXSID90203740 |
EX-A1288 |
FT-0700330 |
GTPL5749 |
HY-14751 |
J-690322 |
J7Z9DBN8J0 |
MFCD23105917 |
MolPort-035-942-975 |
MolPort-044-567-688 |
NLE429IZUC |
PB37313 |
Q-4560 |
QC-11703 |
Rolapitant |
Rolapitant (USAN/INN) |
Rolapitant [USAN:INN] |
Rolapitant HCl |
rolapitant hydrochloride (anhydrous) |
Rolapitant hydrochloride (USAN) |
Rolapitant hydrochloride [USAN] |
Rolapitant hydrochloride anhydrous |
Rolapitant hydrochloride hydrate |
rolapitant monohydrochloride |
rolapitant monohydrochloride monohydrate |
rolapitant.HCl |
rolapitant.HCl.H2O |
Rolapitant(sch619734) |
Sch 619734 |
SCH-619734 |
SCH619734 |
SCHEMBL2173125 |
SCHEMBL354305 |
UNII-57O5S1QSAQ |
UNII-J7Z9DBN8J0 |
UNII-NLE429IZUC |
Varubi |
Varubi (TN) |
ZINC3816514 |
US Patents and Regulatory Information for rolapitant hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
International Patents for rolapitant hydrochloride
Country | Document Number | Estimated Expiration |
---|---|---|
Peru | 05452012 | ➤ Sign Up |
Japan | 2009532473 | ➤ Sign Up |
Japan | 2014058549 | ➤ Sign Up |
World Intellectual Property Organization (WIPO) | 2007114921 | ➤ Sign Up |
Chile | 2008000819 | ➤ Sign Up |
Poland | 370841 | ➤ Sign Up |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for rolapitant hydrochloride
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
2017000080 | Germany | ➤ Sign Up | PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
2017032 | Lithuania | ➤ Sign Up | PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
2017 00041 | Denmark | ➤ Sign Up | PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424 |
0895 | Netherlands | ➤ Sign Up | PRODUCT NAME: ROLAPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN ROLAPITANT HYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180/001 20170424 |
2017000079 | Germany | ➤ Sign Up | PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
2017031 | Lithuania | ➤ Sign Up | PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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