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Genzyme Company Profile

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What is the competitive landscape for GENZYME, and when can generic versions of GENZYME drugs launch?

GENZYME has twelve approved drugs.

There are twelve US patents protecting GENZYME drugs.

There are two hundred and seventy-four patent family members on GENZYME drugs in forty-five countries and fifty-five supplementary protection certificates in sixteen countries.

Summary for Genzyme

International Patents:	274
US Patents:	12
Tradenames:	11
Ingredients:	11
NDAs:	12
Patent Litigation for Genzyme:	See patent lawsuits for Genzyme

Drugs and US Patents for Genzyme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014		RX	Yes	Yes	7,196,205			Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014		RX	Yes	Yes
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014		RX	Yes	Yes	7,253,185		Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	7,173,038		Y	Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,642,608
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	AB	RX	Yes	Yes	9,095,509		Y

Expired US Patents for Genzyme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	6,509,013
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	4,918,179
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	5,496,545
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	5,496,545
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	6,509,013
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	7,459,151

Paragraph IV (Patent) Challenges for GENZYME drugs

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

International Patents for Genzyme Drugs

Country	Patent Number	Estimated Expiration
Japan	2004002406
Japan	5595660
Norway	336989
China	101219145
Eurasian Patent Organization	200200387
Denmark	1411918

Supplementary Protection Certificates for Genzyme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	PA2012015	Lithuania		PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
1244647	1290028-8	Sweden		PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
1244647	C300543	Netherlands		PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1411918	1290023-9	Sweden		PRODUCT NAME: PLERIXAFOR, VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/09/534/001 20090804
1244647	PA2012015,C1244647	Lithuania		PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
1244647	419	Finland

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Genzyme
• Genzyme Corp