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Sevelamer carbonate - Generic Drug Details
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What are the generic drug sources for sevelamer carbonate and what is the scope of patent protection?
Sevelamer carbonate
is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sanofi, Amneal Pharms Co, Anxin, Impax Labs Inc, Indicus Pharma, Invagen Pharms, Mylan, Twi Pharms, and Zydus Pharms, and is included in fourteen 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. Eighteen suppliers are listed for this compound.
Summary for sevelamer carbonate
International Patents: | 55 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 14 |
Drug Master File Entries: | 32 |
Suppliers / Packagers: | 18 |
Bulk Api Vendors: | 16 |
Clinical Trials: | 50 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
Shanghai Alebund Pharmaceuticals Limited | Phase 2 |
Akebia Therapeutics | Phase 1 |
Panion & BF Biotech Inc. | Phase 3 |
Pharmacology for sevelamer carbonate
Drug Class | Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Dr Reddys Labs Ltd | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 206094-001 | Sep 29, 2017 | AB | RX | No | 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 | Y | Start Trial | ||
Amneal Pharms Co | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 207288-001 | Nov 28, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 201069-001 | Aug 5, 2020 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Invagen Pharms | SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 203860-001 | Oct 26, 2017 | AB | RX | No | 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 |
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 | 022318-002 | Feb 18, 2009 | 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 sevelamer carbonate
Country | Patent Number | Estimated Expiration |
---|---|---|
Poland | 1924246 | Start Trial |
World Intellectual Property Organization (WIPO) | 2007035313 | Start Trial |
Spain | 2621553 | Start Trial |
Australia | 2005302243 | Start Trial |
Croatia | P20170505 | Start Trial |
Spain | 2716982 | 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 | 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 | C00716606/01 | Switzerland | Start Trial | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
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 | 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 |
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