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 one patent family members on GENZYME drugs in fifty countries and sixty-four supplementary protection certificates in seventeen countries.
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 | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | 9,095,509 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | DISCN | Yes | No | ⤷ 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 | 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 | 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 | 10,888,547 | ⤷ 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 Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | 6,414,148 | ⤷ Try a Trial |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | 7,173,038 | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | 5,667,775 | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | 5,496,545 | ⤷ Try a Trial |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | 7,459,151 | ⤷ Try a Trial |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | 6,858,203 | ⤷ Try a Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | CAPSULE;ORAL | 020926-001 | Oct 30, 1998 | 6,509,013 | ⤷ 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 | 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 |
| ➤ Subscribe | Tartrate Capsules | 84mg | ➤ Subscribe | 2018-08-20 |
International Patents for Genzyme Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 3083663 | ⤷ Try a Trial |
| Spain | 2556217 | ⤷ Try a Trial |
| China | 116139130 | ⤷ Try a Trial |
| Singapore | 11202004954Y | ⤷ Try a Trial |
| Argentina | 110045 | ⤷ Try a Trial |
| Japan | 2019001809 | ⤷ Try a Trial |
| South Africa | 200609110 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Genzyme Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411918 | PA2012011 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 1411918 | PA2012011,C1411918 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 2371361 | CA 2019 00044 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731 |
| 0619813 | SPC/GB10/004 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTERED: UK EU/1/09/537/001 20090731; REASON FOR LAPSE: SURRENDERED |
| 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 |
| 1411918 | SPC/GB12/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTERED: UK EU/1/09/537/001 20090804 |
| 1411918 | 1290023-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR, VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/09/534/001 20090804 |
| >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.
