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Last Updated: March 19, 2024

Genzyme Company Profile


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Summary for Genzyme
International Patents:201
US Patents:6
Tradenames:8
Ingredients:8
NDAs:9
Patent Litigation for Genzyme: See patent lawsuits for Genzyme

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 CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes 10,888,547 ⤷  Try a Trial ⤷  Try a Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes 10,888,544 ⤷  Try a Trial ⤷  Try a Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes 9,095,509 ⤷  Try a Trial Y ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No 8,067,427 ⤷  Try a Trial Y ⤷  Try a Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes 11,458,119 ⤷  Try a Trial Y Y ⤷  Try a Trial
Genzyme Corp FLUDARA fludarabine phosphate INJECTABLE;INJECTION 020038-001 Apr 18, 1991 DISCN Yes No ⤷  Try a Trial ⤷  Try a 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 021179-002 Jul 12, 2000 7,459,151 ⤷  Try a Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 7,014,846 ⤷  Try a Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 5,667,775 ⤷  Try a Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 7,253,185 ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 8,642,608 ⤷  Try a Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 7,459,151 ⤷  Try a Trial
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 5,496,545 ⤷  Try a 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 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
➤ 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

Supplementary Protection Certificates for Genzyme Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2371361 2090003-1 Sweden ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/537/001 20090804
1409467 2015/027 Ireland ⤷  Try a Trial PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
0473708 SPC/GB06/040 United Kingdom ⤷  Try a 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
1411918 C 2012 019 Romania ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731
0716606 C300080 Netherlands ⤷  Try a Trial 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
0716606 SPC/GB02/011 United Kingdom ⤷  Try a Trial PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
1244647 12C0048 France ⤷  Try a Trial PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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