DrugPatentWatch Database Preview
VARUBI Drug Profile
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When do Varubi patents expire, and when can generic versions of Varubi launch?
This drug has one hundred and fifty-three patent family members in thirty-four 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: | 153 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 6 |
| Clinical Trials: | 4 |
| Patent Applications: | 31 |
| 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 |
| (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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tesaro Inc | VARUBI | rolapitant hydrochloride | EMULSION;IV (INFUSION) | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Tesaro Inc | VARUBI | rolapitant hydrochloride | EMULSION;IV (INFUSION) | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Tesaro Inc | VARUBI | rolapitant hydrochloride | EMULSION;IV (INFUSION) | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Tesaro Inc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ➤ 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 |
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Non-Orange Book US Patents for VARUBI
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,902,366 | NK.sub.1 antagonists | ➤ Try a Free Trial |
| 9,688,693 | NK.sub.1 antagonists | ➤ Try a Free Trial |
| 9,345,692 | Pharmaceutical formulations: salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxy-methyl]-8-phenyl-1,7-diaza-s- piro[4.5]decan-2-one and treatment methods using the same | ➤ Try a Free Trial |
| 8,273,895 | NK.sub.1 antagonists | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for VARUBI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Peru | 23292014 | ➤ Try a Free Trial |
| Portugal | 1463716 | ➤ Try a Free Trial |
| Singapore | 180017 | ➤ Try a Free Trial |
| Singapore | 170838 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for VARUBI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0895 | Netherlands | ➤ Try a Free Trial | 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 |
| 2017031 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
| 2017 00041 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424 |
| 2017000080 | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
