Tersera Company Profile

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TERSERA has six approved drugs.

There are fourteen US patents protecting TERSERA drugs.

There are two hundred and fifteen patent family members on TERSERA drugs in thirty-eight countries and thirty-nine supplementary protection certificates in eighteen countries.

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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	8,404,702	⤷ Start Trial				⤷ Start Trial
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	7,563,801	⤷ Start Trial	Y			⤷ Start Trial
Tersera	QMIIZ ODT	meloxicam	TABLET, ORALLY DISINTEGRATING;ORAL	211210-002	Oct 19, 2018		DISCN	Yes	No	8,545,879	⤷ Start Trial	Y			⤷ Start Trial
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	8,178,550	⤷ Start Trial	Y	Y		⤷ Start 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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	5,366,734	⤷ Start Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	4,100,274	⤷ Start Trial
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017	8,796,299	⤷ Start Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	7,220,247	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1463716	1790044-0	Sweden	⤷ Start Trial	PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/17/1180/001 20170424
1463716	C201730043	Spain	⤷ Start 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
2091940	C02091940/01	Switzerland	⤷ Start Trial	PRODUCT NAME: TELOTRISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66374 28.03.2018
1463716	LUC00043	Luxembourg	⤷ Start Trial	PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1180/001 20170424
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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