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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 patent family members on GENZYME drugs in forty-five countries and fifty-three supplementary protection certificates in fifteen countries.

Summary for Genzyme

International Patents:	270
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	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	RE42353		Y	Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	7,173,038		Y	Y
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008		RX	Yes	Yes	6,987,102
Genzyme	CEREDASE	alglucerase	INJECTABLE;INJECTION	020057-003	Apr 5, 1991		DISCN	No	No
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008		RX	Yes	Yes	7,897,590

Expired US Patents for Genzyme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	5,496,545
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	7,014,846
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	4,918,179
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	7,459,151
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	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
Portugal	1924246
Canada	2378600
World Intellectual Property Organization (WIPO)	2005000333
Japan	3522727
Japan	2006526646

Supplementary Protection Certificates for Genzyme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411918	2012/028	Ireland		PRODUCT NAME: PLERIXAFOR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
0219829	SPC/GB06/034	United Kingdom		PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
1244647	C01244647/01	Switzerland		FORMER OWNER: ASTRAZENECA AB, SE
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
1411918	C20120014 00064	Estonia		PRODUCT NAME: MOZOBIL - PLERIXAFOR;REG NO/DATE: C(2009)6238 31.07.2009

Similar Applicant Names

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

• Genzyme
• Genzyme Corp