Emd Serono Company Profile

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EMD SERONO has nine approved drugs.

There are thirteen US patents protecting EMD SERONO drugs.

There are one hundred and ninety-seven patent family members on EMD SERONO drugs in forty-two countries and eighty-nine 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	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	9,403,799	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	GLUCOPHAGE	metformin hydrochloride	TABLET;ORAL	020357-001	Mar 3, 1995		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	GLUCOPHAGE	metformin hydrochloride	TABLET;ORAL	020357-003	Nov 5, 1998		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	7,888,328	⤷ Sign Up	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997	4,517,181	⤷ Sign Up
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	6,475,521	⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000	6,319,192	⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	7,605,121	⤷ Sign Up
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	4,197,249	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Country	Patent Number	Estimated Expiration
Singapore	183739	⤷ Sign Up
Brazil	122018068797	⤷ Sign Up
Croatia	P20050925	⤷ Sign Up
Eurasian Patent Organization	015799	⤷ Sign Up
New Zealand	583187	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C 2014 029	Romania	⤷ Sign Up	PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1608344	C 2018 010	Romania	⤷ Sign Up	PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822
1532149	132013902118390	Italy	⤷ Sign Up	PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
2164843	CA 2022 00021	Denmark	⤷ Sign Up	PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217
2805723	LUC00064	Luxembourg	⤷ Sign Up	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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