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 nine approved drugs.
There are six US patents protecting GENZYME drugs.
There are two hundred and two patent family members on GENZYME drugs in fifty countries and sixty-four supplementary protection certificates in seventeen countries.
Summary for Genzyme
| International Patents: | 202 |
| US Patents: | 6 |
| 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 | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | 10,888,544 | ⤷ 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 | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | 8,067,427 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | 7,196,205 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | 10,888,547 | ⤷ Sign Up | ⤷ Sign Up | |||
| Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | DISCN | Yes | No | ⤷ 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 |
Expired US Patents for Genzyme
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | 4,357,324*PED | ⤷ Sign Up |
| Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | 4,918,179 | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | 6,858,203 | ⤷ Sign Up |
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | 7,253,185 | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | 6,509,013 | ⤷ Sign Up |
| Genzyme | RENAGEL | sevelamer hydrochloride | CAPSULE;ORAL | 020926-001 | Oct 30, 1998 | 5,496,545 | ⤷ Sign Up |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | 7,173,038 | ⤷ Sign Up |
| >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 | 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 |
| ➤ Subscribe | Injection | 24 mg/1.2 mL vials (20 mg/mL) | ➤ Subscribe | 2012-12-17 |
International Patents for Genzyme Drugs
Supplementary Protection Certificates for Genzyme Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0716606 | 6/2002 | Austria | ⤷ Sign Up | PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128 |
| 1411918 | 2012C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804 |
| 1409467 | 37/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| 1244647 | 2012C/036 | Belgium | ⤷ Sign Up | PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221 |
| 1411918 | SPC/GB12/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTERED: UK EU/1/09/537/001 20090804 |
| 0473708 | SPC/GB06/040 | United Kingdom | ⤷ Sign Up | 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 |
| 0473708 | 06C0038 | France | ⤷ Sign Up | PRODUCT NAME: CLOFARABINE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/334/001 DU 20060529; REGISTRATION NO/DATE AT EEC: EU/1/06/334/001 DU 20060529 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
