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RENVELA Drug Profile
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When 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-four 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-three suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for RENVELA
| International Patents: | 54 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| 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 |
| Amgen | 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 | |||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | AB | RX | Yes | No | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RENVELA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2016047849 | Start Trial |
| Israel | 253711 | Start Trial |
| Spain | 2556217 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006050315 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RENVELA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0716606 | 49/2009 | Austria | Start Trial | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 |
| 0716606 | C300428 | Netherlands | Start Trial | PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610 |
| 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 | SPC/GB02/011 | United Kingdom | Start Trial | PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
