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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Cerilliant
McKesson
UBS
QuintilesIMS
Johnson and Johnson
Express Scripts
Baxter

Generated: September 21, 2018

DrugPatentWatch Database Preview

Genzyme Company Profile

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What is the competitive landscape for GENZYME, and what generic alternatives to GENZYME drugs are available?

GENZYME has twelve approved drugs.

There are fourteen US patents protecting GENZYME drugs.

Summary for Genzyme
US Patents:14
Tradenames:11
Ingredients:11
NDAs:12
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 RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 RX Yes No 6,733,780 ➤ Sign Up Y ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No 9,095,509 ➤ Sign Up Y ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No 8,642,608 ➤ Sign Up ➤ Sign Up
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes 7,897,590 ➤ Sign Up ➤ Sign Up
Genzyme THYROGEN thyrotropin alfa INJECTABLE;INJECTION 020898-001 Nov 30, 1998 RX Yes Yes ➤ Sign Up ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes 8,067,427 ➤ Sign Up Y ➤ Sign Up
Genzyme CEREZYME imiglucerase INJECTABLE;INJECTION 020367-002 Sep 22, 1999 RX Yes Yes ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 5,667,775 ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 7,014,846 ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 6,509,013 ➤ Sign Up
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 5,583,131 ➤ Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 6,414,148 ➤ Sign Up
Genzyme THYROGEN thyrotropin alfa INJECTABLE;INJECTION 020898-001 Nov 30, 1998 6,114,144 ➤ Sign Up
Genzyme CEREZYME imiglucerase INJECTABLE;INJECTION 020367-002 Sep 22, 1999 5,549,892 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for GENZYME drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 800 mg ➤ Subscribe 2008-12-04
➤ Subscribe Injection 1 mg/mL, 20 mL vial ➤ Subscribe 2012-02-23
➤ 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

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
6,255,336 Amino ceramide-like compounds and therapeutic methods of use ➤ Sign Up
7,265,228 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors ➤ Sign Up
5,583,131 Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity ➤ Sign Up
6,569,889 Amino ceramide-like compounds and therapeutic methods of use ➤ Sign Up
9,040,548 Quinazoline derivatives as VEGF inhibitors ➤ Sign Up
6,414,148 Quinazoline derivatives and pharmaceutical compositions containing them ➤ Sign Up
5,034,518 2-fluoro-9-(2-deoxy-2-fluoro-.beta.-D-arabinofuranosyl) adenine nucleosides ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Genzyme Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C038/2009 Ireland ➤ Sign Up SPC038/2009: 20101001, EXPIRES: 20171215
0150027 00161 Estonia ➤ Sign Up PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
0537 Netherlands ➤ Sign Up PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
/2015 Austria ➤ Sign Up PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
033 Luxembourg ➤ Sign Up 92033, EXPIRES: 20240731
2015000051 Germany ➤ Sign Up PRODUCT NAME: ELIGLUSTAT, GGF. IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
C0011 France ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Fuji
Baxter
Medtronic
Citi
Cipla
Daiichi Sankyo
Colorcon
Fish and Richardson

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