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RENVELA Drug Profile
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Which patents cover Renvela, and what generic alternatives are available?
Renvela is a drug marketed by Genzyme and Sanofi and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has fifty-five 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. Additional details are available on the sevelamer carbonate profile page.
US ANDA Litigation and Generic Entry Outlook for Renvela
A generic version of RENVELA was approved as sevelamer carbonate by AUROBINDO PHARMA LTD on June 13th, 2017.
Summary for RENVELA
| International Patents: | 55 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Bulk Api Vendors: | 16 |
| Clinical Trials: | 24 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RENVELA |
| Drug Sales Revenues: | Drug sales revenues for RENVELA |
| DailyMed Link: | RENVELA at DailyMed |
Recent Clinical Trials for RENVELA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Alebund Pharmaceuticals Limited | Phase 2 |
| Sinomune Pharmaceutical Co., Ltd | Phase 3 |
| Vifor Fresenius Medical Care Renal Pharma | Phase 3 |
Paragraph IV (Patent) Challenges for RENVELA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RENVELA | FOR SUSPENSION;ORAL | sevelamer carbonate | 022318 | 2009-12-30 |
| RENVELA | TABLET;ORAL | sevelamer carbonate | 022127 | 2008-12-04 |
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 | Start Trial | Start Trial | Y | Start Trial | ||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 RENVELA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | Start Trial | Start Trial |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | Start Trial | Start Trial |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | Start Trial | Start Trial |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | Start Trial | Start Trial |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RENVELA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | 1807057 | Start Trial |
| Japan | 5595660 | Start Trial |
| South Korea | 101547925 | Start Trial |
| Germany | 69434726 | Start Trial |
| China | 103027896 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RENVELA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0716606 | 91629 | Luxembourg | Start Trial | 91629, EXPIRES: 20190810 |
| 0716606 | C300080 | Netherlands | Start Trial | 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 |
| 0716606 | SPC004/2002 | Ireland | Start Trial | SPC004/2002, 20040614, EXPIRES: 20150127 |
| 0716606 | 49/2009 | Austria | Start Trial | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 |
| 0716606 | CA 2009 00048 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
