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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:	5
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	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	RE42353		Y	Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,642,608
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	AP	RX	Yes	No
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	AB	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	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,602,116
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,707,980
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,861,386
Genzyme Corp	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	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
8,138,353	Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
8,779,163	Synthesis of UDP-Glucose: N-acylsphingosine glucosyl transferase inhibitors
6,030,995	Amino ceramide-like compounds and therapeutic methods of use
6,855,830	Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors

International Patents for Genzyme Corp Drugs

Country	Document Number	Estimated Expiration
European Patent Office	1409467
Malaysia	129540
Australia	769222
Portugal	1676845

Supplementary Protection Certificates for Genzyme Corp Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90029-3	Sweden		PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
/2015	Austria		PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
2015000051	Germany		PRODUCT NAME: ELIGLUSTAT, GGF. IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
9	Finland

Similar Applicant Names

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

• Genzyme
• Genzyme Corp