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Emd Serono Company Profile

EMD SERONO has eight approved drugs.

There are four US patents protecting EMD SERONO drugs.

There are one hundred and eleven patent family members on EMD SERONO drugs in thirty-three countries and sixty-four supplementary protection certificates in sixteen 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
Emd Serono Inc	GLUCOPHAGE	metformin hydrochloride	TABLET;ORAL	020357-004	Nov 5, 1998		DISCN	Yes	No		Start Trial				Start Trial
Emd Serono	SEROPHENE	clomiphene citrate	TABLET;ORAL	018361-001	Mar 22, 1982		DISCN	No	No		Start Trial				Start Trial
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes		Start Trial				Start Trial
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987		DISCN	Yes	No		Start Trial				Start Trial
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	7,888,328	Start Trial	Y			Start Trial
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000		DISCN	Yes	No		Start Trial				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
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	6,475,521	Start Trial
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	4,617,319	Start Trial
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997	4,703,035	Start Trial
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000	7,605,121	Start Trial
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	6,660,300	Start Trial
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000	4,800,191	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
1827461	132018000000141	Italy	Start Trial	PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
1730131	C01730131/02	Switzerland	Start Trial	PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1506211	179 5017-2014	Slovakia	Start Trial	PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1261586	C01261586/02	Switzerland	Start Trial	PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1827461	2018C/010	Belgium	Start Trial	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
2498758	CA 2020 00017	Denmark	Start Trial	PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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