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Genzyme Company Profile

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What is the competitive landscape for GENZYME, and what generic alternatives to GENZYME drugs are available?

GENZYME has nine approved drugs.

There are thirteen US patents protecting GENZYME drugs.

There are three hundred and thirty-nine patent family members on GENZYME drugs in fifty-eight countries and seventy-one supplementary protection certificates in seventeen countries.

Summary for Genzyme

International Patents:	339
US Patents:	13
Tradenames:	8
Ingredients:	8
NDAs:	9
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	7,173,038		Y	Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	6,916,802			Y
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	AB	RX	Yes	No
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008		RX	Yes	Yes	7,897,590
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,067,427		Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	RE42353		Y	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	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	5,496,545
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	6,858,203
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	7,459,151
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	7,014,846
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	6,414,148

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
Poland	2796457
China	100376567
Estonia	05330
Japan	2008195730
European Patent Office	1409467
European Patent Office	1924246

Supplementary Protection Certificates for Genzyme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	2012C/036	Belgium		PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221
1244647	PA2012015,C1244647	Lithuania		PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
1411918	SPC/GB12/031	United Kingdom		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTERED: UK EU/1/09/537/001 20090804
0716606	C300080	Netherlands		PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606	C00716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004

Similar Applicant Names

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

• Genzyme
• Genzyme Corp