Genzyme Company Profile

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GENZYME has nine approved drugs.

There are six US patents protecting GENZYME drugs.

There are two hundred and two patent family members on GENZYME drugs in fifty countries and sixty-four supplementary protection certificates in seventeen countries.

International Patents:	202
US Patents:	6
Tradenames:	8
Ingredients:	8
NDAs:	9
Patent Litigation for Genzyme:	See patent lawsuits for Genzyme

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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
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	AB	RX	Yes	Yes	9,095,509	⤷ Sign Up	Y			⤷ Sign Up
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	10,888,544	⤷ Sign Up				⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	AB	RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	AP	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	AP	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	11,458,119	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	8,642,608	⤷ Sign Up
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	6,509,013	⤷ Sign Up
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	7,253,185	⤷ Sign Up
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	6,987,102	⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	5,667,775	⤷ Sign Up
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	5,667,775	⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	5,496,545	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	400 mg and 800 mg	➤ Subscribe	2008-05-22
➤ Subscribe	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet	➤ Subscribe	2009-12-30
➤ Subscribe	Injection	24 mg/1.2 mL vials (20 mg/mL)	➤ Subscribe	2012-12-17
➤ Subscribe	Tablets	800 mg	➤ Subscribe	2008-12-04
➤ Subscribe	Injection	1 mg/mL, 20 mL vial	➤ Subscribe	2012-02-23
➤ Subscribe	Tartrate Capsules	84mg	➤ Subscribe	2018-08-20

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Country	Patent Number	Estimated Expiration
Peru	20171255	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011066352	⤷ Sign Up
Canada	3075788	⤷ Sign Up
Poland	3599237	⤷ Sign Up
Australia	2005244650	⤷ Sign Up
Brazil	PI0211379	⤷ Sign Up
Poland	1924246	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	122019000082	Germany	⤷ Sign Up	PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER EIN PHARMAZEUTISCH ANNEHMBARER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	CA 2012 00026	Denmark	⤷ Sign Up	PRODUCT NAME: PLERIXAFOR I ALLE FORMER SOM BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/01/09/537/001 20090804
0716606	02C0011	France	⤷ Sign Up	PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
1409467	1590029-3	Sweden	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
2371361	C02371361/01	Switzerland	⤷ Sign Up	PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63139 15.08.2014
1244647	C 2012 023	Romania	⤷ Sign Up	PRODUCT NAME: VANDETANIB SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/749/001, RO EU/1/11/749/002; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/749/001, EMEA EU/1/11/749/002; DATE OF FIRST AUTHORISATION IN EEA: 20120217
0716606	6/2002	Austria	⤷ Sign Up	PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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