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Genzyme Corp Company Profile

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What is the competitive landscape for GENZYME CORP, and when can generic versions of GENZYME CORP drugs launch?

GENZYME CORP has five approved drugs.

There are eight US patents protecting GENZYME CORP drugs.

There are one hundred and sixty-five patent family members on GENZYME CORP drugs in forty-two countries and twenty-four supplementary protection certificates in fourteen countries.

Summary for Genzyme Corp

International Patents:	165
US Patents:	8
Tradenames:	4
Ingredients:	4
NDAs:	5
Drug Master File Entries:	9
Patent Litigation for Genzyme Corp:	See patent lawsuits for Genzyme Corp

Drugs and US Patents for Genzyme Corp

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme Corp	FLUDARA	fludarabine phosphate	INJECTABLE;INJECTION	020038-001	Apr 18, 1991		DISCN	Yes	No
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,642,608
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,642,608
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	AB	RX	Yes	No
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	AP	RX	Yes	Yes
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	7,173,038		Y	Y

Expired US Patents for Genzyme Corp

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,707,980
Genzyme Corp	FLUDARA	fludarabine phosphate	INJECTABLE;INJECTION	020038-001	Apr 18, 1991	4,357,324*PED
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	5,602,116
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	5,602,116
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	6,414,148
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,602,116

Paragraph IV (Patent) Challenges for GENZYME CORP drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	0.5 mcg and 2.5 mcg		2009-03-25
	Capsules	1 mcg		2010-02-12
	Injection	2 mcg/mL, 2 mL ampules		2007-10-15
	Injection	2 mcg/mL, 1 mL in 2 mL vial		2011-12-28

Non-Orange Book US Patents for Genzyme Corp

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
6,855,830	Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
8,779,163	Synthesis of UDP-Glucose: N-acylsphingosine glucosyl transferase inhibitors
6,569,889	Amino ceramide-like compounds and therapeutic methods of use
6,890,949	Amino ceramide-like compounds and therapeutic methods of use
5,916,911	Amino ceramide--like compounds and therapeutic methods of use
9,040,548	Quinazoline derivatives as VEGF inhibitors

International Patents for Genzyme Corp Drugs

Country	Document Number	Estimated Expiration
Norway	2012014
United Kingdom	0411378
Israel	193244
Spain	2395463
Mexico	PA06013501
Israel	149034

Supplementary Protection Certificates for Genzyme Corp Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647/01	Switzerland		FORMER OWNER: ASTRAZENECA AB, SE
/2015	Austria		PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
2015 00035	Denmark		PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
C0048	France		PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
00738	Netherlands		PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119
0150027 00161	Estonia		PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015

Similar Applicant Names

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

• Genzyme
• Genzyme Corp