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Generated: October 23, 2018

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Sevelamer hydrochloride - Generic Drug Details

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What are the generic drug sources for sevelamer hydrochloride and what is the scope of sevelamer hydrochloride patent protection?

Sevelamer hydrochloride is the generic ingredient in one branded drug marketed by Genzyme and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for sevelamer hydrochloride. Five suppliers are listed for this compound.

Pharmacology for sevelamer hydrochloride
Synonyms for sevelamer hydrochloride
(C3H7N)m.(C3H5ClO)n.(HCl)x
152751-57-0
182683-00-7
198343-01-0
2-(chloromethyl)oxirane; prop-2-en-1-amine; hydrochloride
2-Propen-1-amine polymer with (chloromethyl)oxirane hydrochloride
2-Propen-1-amine, hydrochloride, polymer with (chloromethyl)oxirane
2-propen-1-amine,hydrochloride,polymer with (chloromethyl)oxirane
AB01568265_01
AC-2089
AC1L4LHX
AC1Q3UBQ
AKOS025149504
Allylamine hydrochloride - epichlorhydrin copolymer
AN-14277
BC226808
CHEBI:32127
CTK4E2490
D01983
D03MZQ
FT-0653684
GLS2PGI8QG
GT 16-026A
HS-0082
KHNXRSIBRKBJDI-UHFFFAOYSA-N
LS-181811
MolPort-005-943-544
MolPort-039-138-690
Oxirane, (chloromethyl)-, polymer with 2-propen-1-amine hydrochloride
PB 94
Phosblock
prop-2-en-1-amine- 2-(chloromethyl)oxirane hydrochloride(1:1:1)
RenaGel
Renastat
Renestat
s4129
Sevelamer HCl
Sevelamer hydrochloride (JAN/USAN)
Sevelamer hydrochloride [USAN]
SEVELAMERHCL
UNII-GLS2PGI8QG

US Patents and Regulatory Information for sevelamer hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for sevelamer hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for sevelamer hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0011 France ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
C/GB02/011 United Kingdom ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
2002 Austria ➤ Sign Up PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
00080 Netherlands ➤ Sign Up 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
00428 Netherlands ➤ Sign Up PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
/2009 Austria ➤ Sign Up PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606/01 Switzerland ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Merck
McKesson
Argus Health
Federal Trade Commission
Baxter
Mallinckrodt
QuintilesIMS
Express Scripts

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