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Generated: April 21, 2019

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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 risedronate sodium patent protection?

Risedronate sodium is the generic ingredient in three branded drugs marketed by Apil, Impax Labs Inc, Teva Pharms Usa, Zydus Pharms Usa Inc, Apotex Inc, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan Pharms Inc, and Sun Pharma Global, and is included in fourteen 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 patent family members in fifty-two countries.

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

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
Tentative approvals for RISEDRONATE SODIUM
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial35MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial30MGTABLET;ORAL

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
Sun Pharma Global RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090886-002 Nov 30, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Macleods Pharms Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533-002 Dec 9, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-003 Oct 5, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for risedronate sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0998292 PA2006002 Lithuania ➤ Try a Free Trial PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
0998292 PA2006002,C0998292 Lithuania ➤ Try a Free Trial PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
1175904 2007C/048 Belgium ➤ Try a Free Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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Teva
Cipla
Colorcon

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