Genzyme Company Profile

What is the competitive landscape for GENZYME

GENZYME has eleven approved drugs.

There are sixteen US patents protecting GENZYME drugs.

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

Summary for Genzyme

International Patents:	381
US Patents:	16
Tradenames:	10
Ingredients:	10
NDAs:	11

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	AB	RX	Yes	Yes	7,196,205			Y
Genzyme Corp	WAYRILZ	rilzabrutinib	TABLET;ORAL	219685-001	Aug 29, 2025		RX	Yes	Yes	8,940,744		Y	Y
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	AP	RX	Yes	Yes
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998		DISCN	No	No
Genzyme Corp	QFITLIA	fitusiran sodium	SOLUTION;SUBCUTANEOUS	219019-002	Mar 28, 2025		RX	Yes	Yes

Expired US Patents for Genzyme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	7,014,846
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	RE42353
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	6,509,013
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	6,916,802
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	6,509,013

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
South Korea	102139918
European Patent Office	2892900
European Patent Office	4424828
Japan	2021506789
Eurasian Patent Organization	201592195

Supplementary Protection Certificates for Genzyme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
2371361	2019/055	Ireland		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; NAT REGISTRATION NO/DATE: EU/1/09/537/001 20090804; FIRST REGISTRATION NO/DATE: EU/1/09/537/001 04/08/2009 (14/10/2020)
0619813	SPC/GB10/004	United Kingdom		PRODUCT NAME: PLERIXAFOR IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTERED: UK EU/1/09/537/001 20090731; REASON FOR LAPSE: SURRENDERED
1244647	300543	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

Similar Applicant Names

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

• Genzyme
• Genzyme Corp