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Genzyme Company Profile

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

GENZYME has fifteen approved drugs.

There are fourteen US patents protecting GENZYME drugs.

There are three hundred and thirty-one patent family members on GENZYME drugs in forty-six countries and fifty-four supplementary protection certificates in fourteen countries.

Summary for Genzyme

International Patents:	331
US Patents:	14
Tradenames:	12
Ingredients:	12
NDAs:	15

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	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	7,173,038		Y	Y
Genzyme Corp	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	AP	RX	Yes	Yes
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014		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	7,459,151
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998	6,509,013
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	5,496,545
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	5,496,545

Paragraph IV (Patent) Challenges for GENZYME drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	0.5 mcg and 2.5 mcg		2009-03-25
	Tablets	800 mg		2008-12-04
	Capsules	1 mcg		2010-02-12
	Injection	2 mcg/mL, 1 mL in 2 mL vial		2011-12-28
	Injection	24 mg/1.2 mL vials (20 mg/mL)		2012-12-17
	Injection	2 mcg/mL, 2 mL ampules		2007-10-15
	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	1 mg/mL, 20 mL vial		2012-02-23

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
8,187,631	Direct compression polymer tablet core
9,579,343	Direct compression polymer tablet core
6,855,830	Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
5,916,911	Amino ceramide--like compounds and therapeutic methods of use

International Patents for Genzyme Drugs

Country	Document Number	Estimated Expiration
Poland	332385
Norway	2016011
South Korea	20080023270
Australia	769222

Supplementary Protection Certificates for Genzyme Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00080	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
717	Luxembourg		PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
00738	Netherlands		PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION 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