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Serving 500+ biopharmaceutical companies globally:

Cipla
Chubb
Medtronic
Accenture
McKinsey
Fuji
Chinese Patent Office
Mallinckrodt
Express Scripts
Teva

Generated: July 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-three patent family members on GENZYME drugs in forty-six countries.

Summary for Applicant: Genzyme

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, 2014RXYesYes6,916,802► Subscribe ► Subscribe
Genzyme
CEREDASE
alglucerase
INJECTABLE;INJECTION020057-003Apr 5, 1991DISCNNoNo► Subscribe► Subscribe
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-002Apr 23, 2004ABRXYesNo► Subscribe► Subscribe
Genzyme Corp
CERDELGA
eliglustat tartrate
CAPSULE;ORAL205494-001Aug 19, 2014RXYesYes► Subscribe► Subscribe
Genzyme
THYROGEN
thyrotropin alfa
INJECTABLE;INJECTION020898-001Nov 30, 1998RXYesYes► Subscribe► Subscribe
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Expired Patents for Genzyme

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20006,509,013► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20005,496,545► Subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 20077,459,151► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 20097,014,846► Subscribe
Genzyme
CEREZYME
imiglucerase
INJECTABLE;INJECTION020367-001May 23, 19945,549,892► 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
6,569,889 Amino ceramide-like compounds and therapeutic methods of use► Subscribe
6,673,803 Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
8,138,353Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors► Subscribe
5,916,911 Amino ceramide--like compounds and therapeutic methods of use► Subscribe
5,945,442 Amino ceramide-like compounds and therapeutic methods of use► 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
Czech Republic286928► Subscribe
Slovakia38999► Subscribe
Austria555102► Subscribe
Russian Federation2383343► Subscribe
JapanH07501816► 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
717Luxembourg► SubscribePRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
/2009Austria► SubscribePRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
/2015Austria► SubscribePRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
C/GB06/034United Kingdom► SubscribePRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
90029-3Sweden► SubscribePRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
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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 500+ biopharmaceutical companies globally:

Baxter
McKesson
UBS
Chinese Patent Office
Harvard Business School
Merck
Boehringer Ingelheim
Deloitte
McKinsey
Moodys

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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