Genzyme Company Profile

What is the competitive landscape for GENZYME

GENZYME has eleven approved drugs.

There are sixteen US patents protecting GENZYME drugs.

Summary for Genzyme

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	WAYRILZ	rilzabrutinib	TABLET;ORAL	219685-001	Aug 29, 2025		RX	Yes	Yes	8,940,744		Y	Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,067,427		Y
Genzyme Corp	WAYRILZ	rilzabrutinib	TABLET;ORAL	219685-001	Aug 29, 2025		RX	Yes	Yes	9,994,576		Y	Y
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	AB	RX	Yes	Yes
Genzyme Corp	QFITLIA	fitusiran sodium	SOLUTION;SUBCUTANEOUS	219019-001	Mar 28, 2025		RX	Yes	Yes	11,091,759
Genzyme Corp	WAYRILZ	rilzabrutinib	TABLET;ORAL	219685-001	Aug 29, 2025		RX	Yes	Yes	9,266,895		Y	Y
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009		DISCN	Yes	No	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	7,014,846
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	8,642,608
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	8,642,608
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	RE42152
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	7,014,846
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998	5,496,545
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
	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
	Tablets	800 mg		2008-12-04
	Injection	1 mg/mL, 20 mL vial		2012-02-23

International Patents for Genzyme Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3133070
Japan	6985283
Japan	2025163155
Taiwan	201639562
Mexico	2015002955
Chile	2014002869
Portugal	1924246

Supplementary Protection Certificates for Genzyme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
2371361	C02371361/01	Switzerland		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63139 15.08.2014
2371361	2019C/544	Belgium		PRODUCT NAME: MOZOBIL - PLERIXAFOR; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
1409467	C20150027 00161	Estonia		PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
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
2371361	5/2020	Austria		PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER EINES PHARMAZEUTISCH ANNEHMBAREN METALLKOMPLEXES; REGISTRATION NO/DATE: EU/1/09/537/001 20090804

Similar Applicant Names

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

• Genzyme
• Genzyme Corp