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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 seven 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:	7
Tradenames:	4
Ingredients:	4
NDAs:	5
Drug Master File Entries:	5

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	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,067,427		Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,067,427		Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014		RX	Yes	Yes
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014		RX	Yes	Yes

Expired US Patents for Genzyme Corp

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	5,602,116
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,869,473
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	5,602,116
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	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
6,890,949	Amino ceramide-like compounds and therapeutic methods of use
6,255,336	Amino ceramide-like compounds and therapeutic methods of use
5,952,370	Amino ceramide-like compounds and therapeutic methods of use
6,414,148	Quinazoline derivatives and pharmaceutical compositions containing them

International Patents for Genzyme Corp Drugs

Country	Document Number	Estimated Expiration
Hungary	229414
New Zealand	550931
Uruguay	28901
China	100376567

Supplementary Protection Certificates for Genzyme Corp Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0543	Netherlands		PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
/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
12/029	Ireland		PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217

Similar Applicant Names

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

• Genzyme
• Genzyme Corp