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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Mallinckrodt
Dow
Medtronic
Covington
Fuji
Johnson and Johnson
QuintilesIMS
Julphar
UBS

Generated: October 23, 2017

DrugPatentWatch Database Preview

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 twelve US patents protecting GENZYME drugs.

There are two hundred and seventy-seven patent family members on GENZYME drugs in forty-six countries and forty-eight supplementary protection certificates in thirteen countries.

Summary for Applicant: Genzyme

International Patents:277
US Patents:12
Tradenames:12
Ingredients:12
NDAs:15
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp
CERDELGA
eliglustat tartrate
CAPSULE;ORAL205494-001Aug 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-001Apr 6, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-002Apr 6, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Genzyme
MOZOBIL
plerixafor
SOLUTION;SUBCUTANEOUS022311-001Dec 15, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Genzyme Corp
CERDELGA
eliglustat tartrate
CAPSULE;ORAL205494-001Aug 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-001Apr 6, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-001Jun 9, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe
Genzyme
LEUPROLIDE ACETATE
leuprolide acetate
INJECTABLE;INJECTION075721-001Nov 29, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Genzyme

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-002Apr 6, 2011► Subscribe► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
CAPSULE;ORAL020926-001Oct 30, 1998► Subscribe► Subscribe
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-001Jun 9, 1999► Subscribe► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 2000► Subscribe► Subscribe
Genzyme Corp
HECTOROL
doxercalciferol
INJECTABLE;INJECTION021027-001Apr 6, 2000► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-003Jul 13, 2009► Subscribe► Subscribe
Genzyme
MOZOBIL
plerixafor
SOLUTION;SUBCUTANEOUS022311-001Dec 15, 2008► Subscribe► Subscribe
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Paragraph IV activity for GENZYME drugs

Drugname Dosage Strength Tradename Submissiondate
plerixafor
Injection24 mg/1.2 mL vials (20 mg/mL)
MOZOBIL
12/17/2012
clofarabine
Injection1 mg/mL, 20 mL vial
CLOLAR
2/23/2012
doxercalciferol
Injection2 mcg/mL, 1 mL in 2 mL vial
HECTOROL
12/28/2011
doxercalciferol
Capsules1 mcg
HECTOROL
2/12/2010
sevelamer carbonate
Powder for Oral Suspension0.8 g/packet and 2.4 g/packet
RENVELA
12/30/2009
doxercalciferol
Capsules0.5 mcg and 2.5 mcg
HECTOROL
3/25/2009
sevelamer carbonate
Tablets800 mg
RENVELA
12/4/2008
sevelamer hydrochloride
Tablets400 mg and 800 mg
RENAGEL
5/22/2008
doxercalciferol
Injection2 mcg/mL, 2 mL ampules
HECTOROL
10/15/2007

Non-Orange Book 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
8,138,353Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors► Subscribe
6,414,148 Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
6,855,830 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors► Subscribe
5,034,518 2-fluoro-9-(2-deoxy-2-fluoro-.beta.-D-arabinofuranosyl) adenine nucleosides► Subscribe
6,051,598 Amino ceramide-like compounds and therapeutic methods of use► Subscribe
8,808,738Aliphatic amine polymer salts for tableting► Subscribe
7,265,228Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors► Subscribe
6,890,949 Amino ceramide-like compounds and therapeutic methods of use► Subscribe
7,169,750Methods to mobilize progenitor/stem cells► Subscribe
7,763,738Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Genzyme Drugs

Country Document Number Estimated Expiration
Japan2005255686► Subscribe
Czech Republic9401188► Subscribe
Australia661086► Subscribe
Czech Republic20021344► Subscribe
European Patent Office1223166► Subscribe
Denmark0929530► Subscribe
World Intellectual Property Organization (WIPO)9220347► Subscribe
Denmark2067775► Subscribe
South Korea20080047458► Subscribe
New Zealand246179► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Genzyme Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90029-3Sweden► SubscribePRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
90028-8Sweden► SubscribePRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
2012015,C1244647Lithuania► SubscribePRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
0120014 00064Estonia► SubscribePRODUCT NAME: MOZOBIL - PLERIXAFOR;REG NO/DATE: C(2009)6238 31.07.2009
2012011Lithuania► SubscribePRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
C0011France► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
C/GB12/031United Kingdom► SubscribePRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTERED: UK EU/1/09/537/001 20090804
/2012Austria► SubscribePRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
12/029Ireland► SubscribePRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
C/GB12/036United Kingdom► SubscribePRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/749/001 20120217; UK EU/1/11/749/002 20120217
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Cantor Fitzgerald
Healthtrust
Mallinckrodt
US Army
Daiichi Sankyo
QuintilesIMS
Chinese Patent Office
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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ISSN: 2162-2639

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