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Last Updated: January 26, 2020

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RISEDRONATE SODIUM - Generic Drug Details

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What are the generic drug sources for risedronate sodium and what is the scope of patent protection?

Risedronate sodium is the generic ingredient in three branded drugs marketed by Apil, Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex Inc, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orchid Hlthcare, and is included in sixteen NDAs. There are nine patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risedronate sodium has two hundred and forty-two patent family members in fifty-two countries.

There are nineteen drug master file entries for risedronate sodium. Thirteen suppliers are listed for this compound.

Drug Prices for RISEDRONATE SODIUM

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Recent Clinical Trials for RISEDRONATE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sheffield Children's NHS Foundation TrustPhase 2
TakedaN/A
Chugai PharmaceuticalPhase 3

See all RISEDRONATE SODIUM clinical trials

Recent Litigation for RISEDRONATE SODIUM

Identify potential future generic entrants

District Court Litigation
Case NameDate
Warner Chilcott Company, LLC v. Teva Pharmaceuticals USA, Inc.2015-04-27
WARNER CHILCOTT COMPANY, LLC v. TEVA PHARMACEUTICALS USA, INC.2011-11-22
WARNER CHILCOTT COMPANY, LLC v. AMNEAL PHARMACEUTICALS, LLC2011-10-12

See all RISEDRONATE SODIUM litigation

Pharmacology for RISEDRONATE SODIUM
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for RISEDRONATE SODIUM
Synonyms for RISEDRONATE SODIUM
[1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic Acid Monosodium Salt
1-hydroxy-1-[hydroxy(sodiooxy)phosphoryl]-2-(pyridin-3-yl)ethylphosphonic acid
1-hydroxy-2-(3-pyridinyl) ethylidene bis-phosphonic acid monosodium salt
105462-24-6 (Parent)
115436-72-1
122458-82-6
2-(3-Pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate
934544-85-1
AB01274790-01
AB09807
AB2000101
AC-20120
AC-732
AC1N5G27
AC1Q1VB7
Acrel
ACT03362
Actonel
Actonel (TN)
AKOS015833432
AN-15580
API0004080
AS-13309
C7H10NNaO7P2
C7H10NO7P2.Na
CCG-213235
CHEBI:8868
CHEMBL1654
CPD000469279
CS0033
CTK8F0842
D00942
DRFDPXKCEWYIAW-UHFFFAOYSA-M
FT-0631078
H864
Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate (Na+)
I02-0324
J10129
K-1095
LS-106650
M2289
MFCD00867080
Monosodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate
Monosodium 1-Hydroxy-2-(3-pyridyl)ethylidene-1,1-diphosphonate
Monosodium Risedronate
NCGC00346521-01
NE 58095
OFG5EXG60L
Optinate
Optinate Septimum
P,P'-[1-Hydroxy-2-(3-pyridonyl)ethylidene]bis-phosphonic acid sodium salt
Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt
Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, monosodium salt
Phosphonic acid, (2-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt
Phosphonic acid, P,P'-[1-hydroxy-2-(3-pyridinyl)ethylidene]bis-, sodium salt (1:1)
Q-201723
Risedronate sodium (USP)
Risedronate sodium [USAN:USP]
Risedronate sodium [USAN]
Risedronate sodium 2.5-hydrate, European Pharmacopoeia (EP) Reference Standard
Risedronate sodium salt
Risedronate Sodium, Pharmaceutical Secondary Standard; Certified Reference Material
Risedronate sodium, United States Pharmacopeia (USP) Reference Standard
Risedronic acid monosodium salt
Risedronic acid sodium salt
risedronic acid, monosodium salt
RTC-070962
s1428
SAM001246537
SCHEMBL18377
sodium hydrogen (1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate
sodium hydrogen-1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethylphosphonate
sodium hydrogen(1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate
sodium hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate
sodium hydroxy-[1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphinate
Sodium risedronate
Sodium trihydrogen (1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonate
TC-070962
UNII-OFG5EXG60L
Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
ATELVIA TABLET, DELAYED RELEASE;ORAL risedronate sodium 022560 2011-06-09
ACTONEL TABLET;ORAL risedronate sodium 020835 2008-08-12
ACTONEL TABLET;ORAL risedronate sodium 020835 2007-09-10
ACTONEL TABLET;ORAL risedronate sodium 020835 2004-04-23

US Patents and Regulatory Information for RISEDRONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 079215-001 Jun 13, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090877-002 Jun 10, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 205280-002 May 13, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090886-005 Jun 10, 2014 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 RISEDRONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RISEDRONATE SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 C01175904/01 Switzerland   Start Trial FORMER OWNER: SCHERING CORPORATION, US
1175904 C300292 Netherlands   Start Trial PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
1175904 91364 Luxembourg   Start Trial 91364, EXPIRES: 20200826
0998292 91222 Luxembourg   Start Trial 91222, EXPIRES: 20200824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Medtronic
AstraZeneca
Mallinckrodt
Colorcon

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