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Sevelamer carbonate - Generic Drug Details
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What are the generic sources for sevelamer carbonate and what is the scope of freedom to operate?
Sevelamer carbonate
is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sanofi, Amneal Pharms Co, Impax Labs Inc, Invagen Pharms, Twi Pharms, and Wilshire Pharms Inc, and is included in eleven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sevelamer carbonate has fifty-five patent family members in twenty-one countries.
There are thirty-two drug master file entries for sevelamer carbonate. Nineteen suppliers are listed for this compound.
Summary for sevelamer carbonate
| International Patents: | 55 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 11 |
| Drug Master File Entries: | 32 |
| Suppliers / Packagers: | 19 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 47 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for sevelamer carbonate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sevelamer carbonate |
| DailyMed Link: | sevelamer carbonate at DailyMed |
Recent Clinical Trials for sevelamer carbonate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Panion & BF Biotech Inc. | Phase 3 |
| Shandong Weigao Panion Pharmaceutical Co. Ltd. | Phase 3 |
| Ardelyx | Phase 4 |
Recent Litigation for sevelamer carbonate
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 sevelamer carbonate
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Synonyms for sevelamer carbonate
| 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 |
| Renvela |
| SC-24770 |
| Sevelamer carbonate [USAN] |
| UNII-9YCX42I8IU |
Paragraph IV (Patent) Challenges for SEVELAMER CARBONATE
| 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 sevelamer carbonate
| 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 | TABLET;ORAL | 207179-001 | Jul 17, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Wilshire Pharms Inc | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 204451-001 | Nov 29, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Impax Labs Inc | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 090975-001 | Oct 23, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Dr Reddys Labs Ltd | SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 210464-002 | Oct 25, 2018 | AB | RX | No | No | 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 | 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 sevelamer carbonate
| 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 | 022318-002 | 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 |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 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 sevelamer carbonate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2621553 | Start Trial |
| Lithuania | 1807057 | Start Trial |
| China | 102824322 | Start Trial |
| Croatia | P20170505 | Start Trial |
| Israel | 239617 | Start Trial |
| Israel | 253711 | Start Trial |
| Mexico | 2007004939 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sevelamer carbonate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0716606 | C00716606/01 | Switzerland | Start Trial | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
| 0716606 | 02C0011 | France | Start Trial | PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 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 |
| 0716606 | C300428 | Netherlands | Start Trial | PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610 |
| 0716606 | 49/2009 | Austria | Start Trial | PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610 |
| 0716606 | SPC/GB02/011 | United Kingdom | Start Trial | PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.