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Generated: August 17, 2017
What are the generic sources for sevelamer carbonate and what is the scope of sevelamer carbonate freedom to operate?
Sevelamer carbonate is the generic ingredient in two branded drugs marketed by Genzyme and Aurobindo Pharma Ltd, and is included in three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: see list | 32 |
| Suppliers / Packagers: see list | 8 |
| Clinical Trials: see list | 197 |
| Therapeutic Class: | Genitourinary Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | sevelamer carbonate at DailyMed |
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 207624-002 | Jun 13, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genzyme | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,585,911 | Sachet formulation for amine polymers | ► Subscribe | |||||||||||||||||||||||||||
| 8,808,738 | Aliphatic amine polymer salts for tableting | ► Subscribe | |||||||||||||||||||||||||||
| 9,555,056 | Aliphatic amine polymer salts for tableting | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 5307398 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2762076 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2007004939 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5922184 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5758945 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2009 | Austria | ► Subscribe | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 | ||||||||||||||||||||||||||
| 0716606/01 | Switzerland | ► Subscribe | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 | ||||||||||||||||||||||||||
| C/GB02/011 | United Kingdom | ► Subscribe | PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202 | ||||||||||||||||||||||||||
| 00080 | Netherlands | ► Subscribe | PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128 | ||||||||||||||||||||||||||
| 00428 | Netherlands | ► Subscribe | PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610 | ||||||||||||||||||||||||||
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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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