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RENVELA Drug Profile
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See Plans and PricingWhen do Renvela patents expire, 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. Twenty suppliers are listed 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 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 15 |
| Clinical Trials: | 22 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RENVELA |
| Drug Sales Revenues: | Drug sales revenues for RENVELA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RENVELA |
| DailyMed Link: | RENVELA at DailyMed |
Recent Clinical Trials for RENVELA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vifor Fresenius Medical Care Renal Pharma | Phase 3 |
| Sanofi | Phase 3 |
| Azienda Ospedaliera Sant'Anna | N/A |
Recent Litigation for RENVELA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Genzyme Corporation v. Endo Pharmaceuticals Inc. | 2011-04-27 |
| Genzyme Corporation v. Lupin Ltd. | 2010-07-14 |
| Genzyme Corporation v. Sandoz, Inc. | 2009-07-02 |
Pharmacology for RENVELA
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Synonyms for RENVELA
| 2-Propen-1-amine polymer with (chloromethyl)oxirane carbonate |
| 845273-93-0 |
| 9YCX42I8IU |
| AN-9605 |
| Carbonic acid, compd. with (chloromethyl)oxirane polymer with 2-propen-1-amine |
| carbonic acid; 2-(chloromethyl)oxirane; prop-2-en-1-amine |
| GT 335-012 |
| HS-0081 |
| KS-00002WUH |
| MolPort-035-869-714 |
| Prop-2-en-1-amine polymer with (Chloromethyl)oxirane carbonate |
| SC-24770 |
| Sevelamer carbonate |
| Sevelamer carbonate [USAN] |
| UNII-9YCX42I8IU |
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 | Start Trial | |||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | 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 | 022318-001 | Aug 12, 2009 | 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 |
|---|---|---|
| Australia | 2006292672 | Start Trial |
| Mexico | 2007004939 | Start Trial |
| Israel | 239617 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RENVELA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0716606 | 02C0011 | France | Start Trial | PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128 |
| 0716606 | 6/2002 | Austria | Start Trial | PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
