TERSERA Company Profile

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TERSERA has seven approved drugs.

There are seventeen US patents protecting TERSERA drugs.

There are two hundred and twenty-one patent family members on TERSERA drugs in thirty-eight countries and forty-one 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	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes	8,765,680	⤷ Sign Up				⤷ Sign Up
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004		RX	Yes	Yes	9,707,270	⤷ Sign Up				⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	9,101,615	⤷ Sign Up				⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	7,981,905	⤷ Sign Up				⤷ Sign Up
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No	8,765,680	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004	8,765,680	⤷ Sign Up
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	7,220,247	⤷ Sign Up
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004	5,795,864	⤷ Sign Up
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004	5,859,186	⤷ Sign Up
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004	8,653,033	⤷ Sign Up
>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
2004646	2017C/040	Belgium	⤷ Sign Up	PRODUCT NAME: ROLAPITANT - VARUBY (SOUS FORME DE CHLORHYDRATE MONOHYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
2091940	1890014-2	Sweden	⤷ Sign Up	PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, IN PARTICULARLY TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920
0835126	05C0027	France	⤷ Sign Up	PRODUCT NAME: ZICONOTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/302/001 DU 20050221; REGISTRATION NO/DATE AT EEC: EU/1/04/302/001-003 DU 20050221
2004646	300898	Netherlands	⤷ Sign Up	PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
1463716	1790044-0	Sweden	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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