DrugPatentWatch Database Preview
Genzyme Company Profile
What is the competitive landscape for GENZYME, and when can generic versions of GENZYME drugs launch?
There are fifteen US patents protecting GENZYME drugs.
There are three hundred and thirty-one patent family members on GENZYME drugs in forty-six countries and fifty-four supplementary protection certificates in fourteen countries.
Summary for Genzyme
| International Patents: | 331 |
| US Patents: | 15 |
| Tradenames: | 12 |
| Ingredients: | 12 |
| NDAs: | 15 |
| 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 | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | 7,173,038 | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | AB | RX | Yes | Yes | 9,095,509 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Genzyme | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | AB | RX | Yes | Yes | 7,985,418 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | RE42353 | ➤ Sign Up | Y | Y | ➤ 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 | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 5,667,775 | ➤ Sign Up |
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | 7,459,151 | ➤ Sign Up |
| Genzyme | THYROGEN | thyrotropin alfa | INJECTABLE;INJECTION | 020898-001 | Nov 30, 1998 | 5,840,566 | ➤ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | 7,014,846 | ➤ 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 | Capsules | 0.5 mcg and 2.5 mcg | ➤ Subscribe | 2009-03-25 |
| ➤ Subscribe | Tablets | 800 mg | ➤ Subscribe | 2008-12-04 |
| ➤ Subscribe | Capsules | 1 mcg | ➤ Subscribe | 2010-02-12 |
| ➤ Subscribe | Injection | 2 mcg/mL, 1 mL in 2 mL vial | ➤ Subscribe | 2011-12-28 |
| ➤ Subscribe | Injection | 24 mg/1.2 mL vials (20 mg/mL) | ➤ Subscribe | 2012-12-17 |
| ➤ Subscribe | Injection | 2 mcg/mL, 2 mL ampules | ➤ Subscribe | 2007-10-15 |
| ➤ 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 | 1 mg/mL, 20 mL vial | ➤ Subscribe | 2012-02-23 |
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 |
|---|---|---|
| 6,569,889 | Amino ceramide-like compounds and therapeutic methods of use | ➤ Sign Up |
| 8,138,353 | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors | ➤ Sign Up |
| 9,585,911 | Sachet formulation for amine polymers | ➤ Sign Up |
| 5,916,911 | Amino ceramide--like compounds and therapeutic methods of use | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Genzyme Drugs
Supplementary Protection Certificates for Genzyme Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0247 | Netherlands | ➤ Sign Up | 300247, 20100523, EXPIRES: 20150522 |
| 2012 00026 | Denmark | ➤ Sign Up | |
| C/GB10/004 | United Kingdom | ➤ Sign Up | PRODUCT NAME: PLERIXAFOR IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTERED: UK EU/1/09/537/001 20090731; REASON FOR LAPSE: SURRENDERED |
| C0038 | 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 |
| 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.
