DrugPatentWatch Database Preview

Genzyme Company Profile

« Back to Dashboard

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

GENZYME has twelve approved drugs.

There are fourteen US patents protecting GENZYME drugs.

Summary for Genzyme

US Patents:	14
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	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000		RX	Yes	No	6,733,780		Y
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	AB	RX	Yes	No	9,095,509		Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,642,608
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008		RX	Yes	Yes	7,897,590
Genzyme	THYROGEN	thyrotropin alfa	INJECTABLE;INJECTION	020898-001	Nov 30, 1998		RX	Yes	Yes
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,067,427		Y
Genzyme	CEREZYME	imiglucerase	INJECTABLE;INJECTION	020367-002	Sep 22, 1999		RX	Yes	Yes

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	5,667,775
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	7,014,846
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	6,509,013
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	5,583,131
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	6,414,148
Genzyme	THYROGEN	thyrotropin alfa	INJECTABLE;INJECTION	020898-001	Nov 30, 1998	6,114,144
Genzyme	CEREZYME	imiglucerase	INJECTABLE;INJECTION	020367-002	Sep 22, 1999	5,549,892

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
	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

Non-Orange Book US Patents for Genzyme

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,255,336	Amino ceramide-like compounds and therapeutic methods of use
7,265,228	Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
5,583,131	Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity
6,569,889	Amino ceramide-like compounds and therapeutic methods of use
9,040,548	Quinazoline derivatives as VEGF inhibitors
6,414,148	Quinazoline derivatives and pharmaceutical compositions containing them
5,034,518	2-fluoro-9-(2-deoxy-2-fluoro-.beta.-D-arabinofuranosyl) adenine nucleosides

International Patents for Genzyme Drugs

Country	Document Number	Estimated Expiration
European Patent Office	2371361
Australia	774960
World Intellectual Property Organization (WIPO)	03011277
Hong Kong	1099220
Denmark	1411918
Germany	69233401
Japan	6182254

Supplementary Protection Certificates for Genzyme Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C038/2009	Ireland		SPC038/2009: 20101001, EXPIRES: 20171215
0150027 00161	Estonia		PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
0537	Netherlands		PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
/2015	Austria		PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
033	Luxembourg		92033, EXPIRES: 20240731
2015000051	Germany		PRODUCT NAME: ELIGLUSTAT, GGF. IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128

Similar Applicant Names

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

• Genzyme
• Genzyme Corp