DrugPatentWatch Database Preview
VARUBI Drug Profile
Which patents cover Varubi, 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.
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
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 4 |
| Patent Applications: | 32 |
| DailyMed Link: | VARUBI at DailyMed |
Generic Entry Opportunity Date for VARUBI
*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 |
| (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 |
| 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 (TN) |
| 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 | ➤ 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 | Y | Y | ➤ 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 | ||||
| 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 | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1882686 | ➤ Sign Up |
| China | 101437821 | ➤ Sign Up |
| Japan | 5763134 | ➤ Sign Up |
| Spain | 2584838 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for VARUBI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017031 | Lithuania | ➤ Sign Up | PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 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 |
| 2017000079 | Germany | ➤ Sign Up | PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
| 0898 | Netherlands | ➤ Sign Up | PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
