ROLAPITANT HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for rolapitant hydrochloride and what is the scope of patent protection?
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 |
Anatomical Therapeutic Chemical (ATC) Classes for ROLAPITANT HYDROCHLORIDE
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 | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ROLAPITANT HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103751186 | Pharmaceutical formulations: salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same | ⤷ Sign Up |
Hungary | E028908 | ⤷ Sign Up | |
Brazil | PI0710577 | formulações farmacêuticas: sais de 8-[{1-(3,5-bis-(trifluorometil)fenil)-etóxi-metil]-8-fenil- 1,7-diaza-espiro[4.5]decan-2-ona e métodos de tratamento usando-se as mesmas | ⤷ Sign Up |
Spain | 2406934 | ⤷ Sign Up | |
Spain | 2372871 | ⤷ Sign Up | |
Peru | 20081891 | FORMULACIONES DE COMPRIMIDOS QUE CONTIENEN SALES DE 8-[{1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-METIL]-8-FENIL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONA Y COMPRIMIDOS ELABORADOS A PARTIR DE ESTAS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ROLAPITANT HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1463716 | 132017000117643 | Italy | ⤷ Sign Up | PRODUCT NAME: ROLAPITANT, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, INCLUSO ROLAPITANT IDROCLORURO MONOIDRATO(VARUBY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1180/001, 20170424 |
2004646 | PA2017031 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
1463716 | 300895 | 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 |
1463716 | 46/2017 | Austria | ⤷ Sign Up | PRODUCT NAME: ROLAPITANT, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, EINSCHLIESSLICH ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 (MITTEILUNG) 20170424 |
2004646 | 122017000079 | Germany | ⤷ Sign Up | PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
1463716 | CR 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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