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Last Updated: August 14, 2020

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Genzyme Company Profile

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Summary for Genzyme
International Patents:281
US Patents:12
Tradenames:8
Ingredients:8
NDAs:9

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 Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes 7,173,038   Start Trial Y Y   Start Trial
Genzyme Corp FLUDARA fludarabine phosphate INJECTABLE;INJECTION 020038-001 Apr 18, 1991 DISCN Yes No   Start Trial   Start Trial
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 AP RX Yes Yes   Start Trial   Start Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes 8,067,427   Start Trial Y   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes 9,095,509   Start Trial Y   Start Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No 8,067,427   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Genzyme

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 7,014,846   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 6,509,013   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 7,459,151   Start Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 6,414,148   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 5,496,545   Start Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 5,583,131   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GENZYME drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 24 mg/1.2 mL vials (20 mg/mL) ➤ Subscribe 2012-12-17
➤ Subscribe Tablets 800 mg ➤ Subscribe 2008-12-04
➤ Subscribe Injection 1 mg/mL, 20 mL vial ➤ Subscribe 2012-02-23
➤ Subscribe Tartrate Capsules 84mg ➤ Subscribe 2018-08-20
➤ Subscribe Tablets 400 mg and 800 mg ➤ Subscribe 2008-05-22
➤ Subscribe Powder for Oral Suspension 0.8 g/packet and 2.4 g/packet ➤ Subscribe 2009-12-30

Supplementary Protection Certificates for Genzyme Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2371361 CA 2019 00044 Denmark   Start Trial PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731
0473708 SPC/GB06/040 United Kingdom   Start Trial PRODUCT NAME: THE USE OF CLOFARABINE (2-CHLORO-9-(2-DEOXY-2-FLUORO-SS-D-ARABINOFURANOSYL)-ADENINE) FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER; 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
1244647 1290028-8 Sweden   Start Trial PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
1244647 419 Finland   Start Trial
1411918 27/2012 Austria   Start Trial PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 LUC00139 Luxembourg   Start Trial PRODUCT NAME: PLERIXAFOR EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN COMPLEXE METALLIFERE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Colorcon
Harvard Business School
Express Scripts
Boehringer Ingelheim

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