DrugPatentWatch Database Preview
VARUBI Drug Profile
When do Varubi patents expire, and when can generic versions of Varubi launch?
Varubi is a drug marketed by Tersera Theraps Llc and is included in two NDAs. There are nine patents protecting this drug.
This drug has one hundred and fifty-nine patent family members in thirty-five countries.
The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.
Summary for VARUBI
| International Patents: | 159 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 4 |
| Patent Applications: | 34 |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for VARUBI |
| DailyMed Link: | VARUBI at DailyMed |
Generic Entry Opportunity Date for VARUBI
Generic Entry Dates for VARUBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
EMULSION;IV (INFUSION) |
Generic Entry Dates for VARUBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for VARUBI
Synonyms for VARUBI
| (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--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--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 |
| 1,7-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 |
| 914462-92-3 |
| ACN-055567 |
| AKOS027250926 |
| AKOS030234023 |
| API0014111 |
| B5910 |
| BC600524 |
| BCP09609 |
| BCP15968 |
| bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one |
| CHEBI:90908 |
| CHEBI:90911 |
| CHEMBL3707330 |
| CHEMBL3707331 |
| CS-6387 |
| D08988 |
| D10742 |
| DB09291 |
| DTXSID70238570 |
| DTXSID90203740 |
| EX-A1288 |
| FT-0700330 |
| GTPL5749 |
| HY-14751 |
| MolPort-035-942-975 |
| NLE429IZUC |
| PB37313 |
| Q-4560 |
| QC-11703 |
| Rolapitant |
| Rolapitant (USAN/INN) |
| Rolapitant [USAN:INN] |
| Rolapitant HCl |
| Rolapitant hydrochloride |
| Rolapitant hydrochloride (USAN) |
| Rolapitant hydrochloride [USAN] |
| Rolapitant hydrochloride hydrate |
| rolapitant monohydrochloride monohydrate |
| rolapitant.HCl.H2O |
| Rolapitant(sch619734) |
| SB20554 |
| Sch 619734 |
| SCH-619734 |
| SCH619734 |
| SCHEMBL2173125 |
| SCHEMBL354305 |
| UNII-57O5S1QSAQ |
| UNII-NLE429IZUC |
| Varubi (TN) |
| Varuby |
| ZINC3816514 |
US Patents and Regulatory Information for VARUBI
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| 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 VARUBI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 2017053 | ➤ Try a Free Trial |
| South Africa | 200808465 | ➤ Try a Free Trial |
| China | 101437821 | ➤ Try a Free Trial |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for VARUBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1463716 | C201730043 | Spain | ➤ Try a Free Trial | PRODUCT NAME: ROLAPITANT, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE, INCLUYENDO ROLAPITANT CLORHIDRATO MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1180; DATE OF AUTHORISATION: 20170420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1180; DATE OF FIRST AUTHORISATION IN EEA: 20170420 |
| 1463716 | 122017000080 | Germany | ➤ Try a Free Trial | PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
| 1463716 | 46/2017 | Austria | ➤ Try a Free Trial | PRODUCT NAME: ROLAPITANT, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, EINSCHLIESSLICH ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 (MITTEILUNG) 20170424 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
