Genzyme Company Profile
What is the competitive landscape for GENZYME
GENZYME has eleven approved drugs.
There are seventeen US patents protecting GENZYME drugs.
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 | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-002 | Mar 28, 2025 | RX | Yes | Yes | 9,127,274 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme Corp | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-001 | Mar 28, 2025 | RX | Yes | Yes | 9,127,274 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | DISCN | Yes | No | ⤷ Start Trial | ⤷ 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 | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | 5,496,545 | ⤷ Start Trial |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | 7,014,846 | ⤷ Start Trial |
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | RE42152 | ⤷ Start Trial |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | 6,414,148 | ⤷ 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 | 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 |
| ➤ Subscribe | Tablets | 400 mg and 800 mg | ➤ Subscribe | 2008-05-22 |
International Patents for Genzyme Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20080047458 | ⤷ Start Trial |
| South Korea | 20140059169 | ⤷ Start Trial |
| Cyprus | 1122611 | ⤷ Start Trial |
| Japan | 2013512252 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Genzyme Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2371361 | 2019C/544 | Belgium | ⤷ Start Trial | PRODUCT NAME: MOZOBIL - PLERIXAFOR; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804 |
| 0473708 | 06C0038 | France | ⤷ Start Trial | 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 |
| 1244647 | 122012000057 | Germany | ⤷ Start Trial | PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217 |
| 1244647 | 2012C/036 | Belgium | ⤷ Start Trial | PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.

