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Generated: July 23, 2017
What is the competitive landscape for GENZYME, and when can generic versions of GENZYME drugs launch?
GENZYME has fifteen approved drugs.| Patents: | 12 |
| Tradenames: | 12 |
| Ingredients: | 12 |
| NDAs: | 15 |
| 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 | RX | Yes | Yes | 6,916,802 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Genzyme | CEREDASE | alglucerase | INJECTABLE;INJECTION | 020057-003 | Apr 5, 1991 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Genzyme Corp | HECTOROL | doxercalciferol | CAPSULE;ORAL | 020862-002 | Apr 23, 2004 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Genzyme | THYROGEN | thyrotropin alfa | INJECTABLE;INJECTION | 020898-001 | Nov 30, 1998 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-002 | Jul 12, 2000 | 6,509,013 | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179-001 | Jul 12, 2000 | 5,496,545 | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 7,459,151 | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | 7,014,846 | ► Subscribe | ||||||||||||||||||||||
Genzyme | CEREZYME | imiglucerase | INJECTABLE;INJECTION | 020367-001 | May 23, 1994 | 5,549,892 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
plerixafor | Injection | 24 mg/1.2 mL vials (20 mg/mL) | MOZOBIL | 12/17/2012 |
clofarabine | Injection | 1 mg/mL, 20 mL vial | CLOLAR | 2/23/2012 |
doxercalciferol | Injection | 2 mcg/mL, 1 mL in 2 mL vial | HECTOROL | 12/28/2011 |
doxercalciferol | Capsules | 1 mcg | HECTOROL | 2/12/2010 |
sevelamer carbonate | Powder for Oral Suspension | 0.8 g/packet and 2.4 g/packet | RENVELA | 12/30/2009 |
doxercalciferol | Capsules | 0.5 mcg and 2.5 mcg | HECTOROL | 3/25/2009 |
sevelamer carbonate | Tablets | 800 mg | RENVELA | 12/4/2008 |
sevelamer hydrochloride | Tablets | 400 mg and 800 mg | RENAGEL | 5/22/2008 |
doxercalciferol | Injection | 2 mcg/mL, 2 mL ampules | HECTOROL | 10/15/2007 |
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 | ► Subscribe | |||||||||||||||||||||||||||
| 6,673,803 | Quinazoline derivatives and pharmaceutical compositions containing them | ► Subscribe | |||||||||||||||||||||||||||
| 8,138,353 | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 5,916,911 | Amino ceramide--like compounds and therapeutic methods of use | ► Subscribe | |||||||||||||||||||||||||||
| 5,945,442 | Amino ceramide-like compounds and therapeutic methods of use | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Czech Republic | 286928 | ► Subscribe | |||||||||||||||||||||||||||
| Slovakia | 38999 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 555102 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2383343 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | H07501816 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 717 | Luxembourg | ► Subscribe | PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121 | ||||||||||||||||||||||||||
| /2009 | Austria | ► Subscribe | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 | ||||||||||||||||||||||||||
| /2015 | Austria | ► Subscribe | PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119 | ||||||||||||||||||||||||||
| C/GB06/034 | United Kingdom | ► Subscribe | PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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 | ||||||||||||||||||||||||||
| 90029-3 | Sweden | ► Subscribe | PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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