Rolapitant hydrochloride - Generic Drug Details
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What are the generic sources for rolapitant hydrochloride and what is the scope of freedom to operate?
Rolapitant hydrochloride
is the generic ingredient in one branded drug marketed by Tersera and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Rolapitant hydrochloride has one hundred and fifty-eight patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for rolapitant hydrochloride
| International Patents: | 158 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 98 |
| Clinical Trials: | 15 |
| Patent Applications: | 729 |
| DailyMed Link: | rolapitant hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for rolapitant hydrochloride
Generic Entry Dates for rolapitant hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;INTRAVENOUS |
Generic Entry Dates for rolapitant hydrochloride*:
Constraining patent/regulatory exclusivity:
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.
Recent Clinical Trials for rolapitant hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Guangxi Medical University | Phase 3 |
| ECONiX Araştırma Analiz ve Danışmanlık A.Ş. | Phase 2 |
| PlusVitech S.L. | Phase 2 |
Pharmacology for rolapitant hydrochloride
| Drug Class | Substance P/Neurokinin-1 Receptor Antagonist |
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Neurokinin 1 Antagonists P-Glycoprotein Inhibitors |
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 | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for rolapitant hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rolapitant hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2012109405 | КОМПОЗИЦИИ АНТАГОНИСТОВ НЕЙРОКИНИНА-1 ДЛЯ ВНУТРИВЕННОГО ВВЕДЕНИЯ | ⤷ Try a Trial |
| Japan | 2010031053 | DERIVATIVE OF PYRROLIDINE AND PIPERIDINE AS NK1 ANTAGONIST | ⤷ Try a Trial |
| Peru | 20120254 | FORMULACIONES FARMACEUTICAS DE SALES DE 8-[1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXIMETIL]-8-FENIL-1,7-DIAZA-ESPIRO[4,5]DECAN-2-ONA | ⤷ Try a Trial |
| Chile | 2007000945 | Formulacion farmaceutica que comprende una sal cristalina de monohidrato de hidrocloruro de (5s,8s)-8-[[(1r)-1-(3,5-bistrifluorometil)fenil]-etoximetil]-8-fenil-1,7-diaza-espiro[4.5]decan-2-ona; capsula que la contiene; y uso en el tratamiento de la emesis y nausea. | ⤷ Try a Trial |
| Taiwan | I498329 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for rolapitant hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1463716 | 2017/042 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
| 2004646 | C201730041 | Spain | ⤷ Try a Trial | PRODUCT NAME: 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 | C20170033 00237 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017 |
| 1463716 | 318 50015-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: ROLAPITANT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1180 20170424 |
| 1463716 | PA2017032,C1463716 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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