DrugPatentWatch Database Preview
RENVELA Drug Profile
When do Renvela patents expire, and what generic alternatives are available?
This drug has fifty-two patent family members in twenty-one countries.
The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for RENVELA
| International Patents: | 52 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 6 |
| Clinical Trials: | 21 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | RENVELA at DailyMed |
Pharmacology for RENVELA
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
US Patents and Regulatory Information for RENVELA
| 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 | 022318-002 | Feb 18, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | 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 RENVELA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ➤ Sign Up | ➤ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ➤ Sign Up | ➤ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ➤ Sign Up | ➤ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for RENVELA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Powder for Oral Suspension | 0.8 g/packet and 2.4 g/packet | ➤ Subscribe | 2009-12-30 |
| ➤ Subscribe | Tablets | 800 mg | ➤ Subscribe | 2008-12-04 |
Non-Orange Book US Patents for RENVELA
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 |
|---|---|---|
| 9,895,315 | Aliphatic amine polymer salts for tableting | ➤ Sign Up |
| 9,585,911 | Sachet formulation for amine polymers | ➤ Sign Up |
| 8,808,738 | Aliphatic amine polymer salts for tableting | ➤ Sign Up |
| 9,555,056 | Aliphatic amine polymer salts for tableting | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for RENVELA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1119155 | ➤ Sign Up |
| South Korea | 101574072 | ➤ Sign Up |
| Portugal | 1924246 | ➤ Sign Up |
| Australia | 2006292672 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for RENVELA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2002 | Austria | ➤ Sign Up | PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128 |
| 0716606/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
| C/GB02/011 | United Kingdom | ➤ Sign Up | PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202 |
| 00080 | Netherlands | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
