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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
Chinese Patent Office
McKinsey
UBS
Colorcon
Express Scripts
Citi
Cipla

Generated: May 21, 2018

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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, Teva Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Sun Pharma Global, and is included in eleven NDAs. There are ten 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 seventy-four patent family members in fifty-two countries.

There are nineteen drug master file entries for risedronate sodium. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for risedronate sodium
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for risedronate sodium
Synonyms for risedronate sodium
(1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid
(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid; sodium
(1-hydroxy-2-(3-pyridinyl)ethylidene)-bis(phosphonic acid) monosodium salt
(1-Hydroxy-2-(3-pyridyl)ethylidene)diphosphonic acid
(1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)bis(phosphonic acid)
(1-hydroxy-2-pyridin-3-ylethane-1,1-diyl)bis(phosphonic acid)
(1-oxidanyl-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
[1-hydroxy-1-phosphono-2-(3-pyridinyl)ethyl]phosphonic acid
[1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphonic acid
[1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonic acid
[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
1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE BIS-PHOSPHONIC ACID
1-Hydroxy-2-(3-pyridyl)-ethan-1,1-bis-phosphonic acid
105462-24-6
105462-24-6 (Parent)
115436-72-1
115436-72-1 (mono-hydrochloride salt)
122458-82-6
2-(3-Pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate
2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid
2689AH
436R721
462R246
934544-85-1
A801245
AB0013898
AB01274790-01
AB01275490_02
AB01275490-01
AB09807
AB2000101
AB2000344
AC-1295
AC-20120
AC-732
AC1L1JX6
AC1N5G27
AC1O3LR2
AC1Q1VB7
Acide risedroniqe
Acide risedronique
Acide risedronique [INN-French]
Acido risedronico
Acido risedronico [INN-Spanish]
Acidum risedronicum
Acidum risedronicum [INN-Latin]
Acrel
ACT03362
Actonel
Actonel (TN)
Actonel 150
AK163014
AK163015
AKOS015833432
AKOS015892564
AKOS024462575
AKOS030228065
AN-15054
AN-15580
API0004080
AS-13309
AS-13584
Atelvia
AX8017640
BB_SC-1157
BC206977
BDBM12576
Benet
BIDD:GT0010
Bisphosphonate 1
C08233
C7H10NNaO7P2
C7H10NO7P2.Na
C7H11NO7P2
C7H11NO7P2.H2O
CCG-213235
CHEBI:8868
CHEBI:8869
CHEMBL1654
CHEMBL923
CPD000469279
CS-1964
CS0033
CTK8F0842
D00942
D08484
D0I7IC
D0PA5S
DB00884
DRFDPXKCEWYIAW-UHFFFAOYSA-M
DTXSID2023563
FT-0631078
FT-0642593
GTPL3176
H864
HE004268
HE292529
HE298537
HMS2090C21
HSDB 7326
HY-B0148
Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate (Na+)
I02-0324
I04-0049
I802
IIDJRNMFWXDHID-UHFFFAOYSA-N
J10129
JMC515594 Compound 64
K-1095
KM2Z91756Z
KS-00000XMN
KS-00000YSA
LS-106650
LS-171967
M-1366
M2289
MFCD00867080
MFCD01706268
MolPort-044-724-030
Monosodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate
Monosodium 1-Hydroxy-2-(3-pyridyl)ethylidene-1,1-diphosphonate
Monosodium Risedronate
Monosodium Risedronate Hemipentahydrate
NCGC00346521-01
NE 58019
NE 58095
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-
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, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-
PubChem14002
Q-201723
RESEDRONIC ACID
Ridron
Ridron (TN)
RIS
Risdronate
RISEDREMATE SODIUM
Risedronate
Risedronate (sodium)
RISEDRONATE NA
Risedronate sodium (USP)
Risedronate sodium [USAN:USP]
Risedronate sodium [USAN]
risedronate sodium anhydrous
Risedronate sodium hydrate
Risedronate sodium monohydrate
Risedronate sodium salt
Risedronic acid
Risedronic acid (Actonel)
Risedronic acid (INN)
Risedronic acid [INN:BAN]
Risedronic acid monohydrate
Risedronic acid monosodium salt
RISEDRONIC ACID SODIUM
Risedronic acid sodium salt
risedronic acid, monosodium salt
RISEDRONIC ACID, SODIUM SALT
Risedronsaure
RTC-070962
s1428
s1874
SAM001246537
SC-14176
SCHEMBL18377
SCHEMBL18378
SCHEMBL2115050
sodium hydrogen (1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate
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 HYDROXY-1-HYDROXY-1-PHOSPHONO-2-(PYRIDIN-3-YL)ETHYLPHOSPHINATE
Sodium risedronate
sodium risedronate hydrate
Sodium trihydrogen (1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonate
TC-070962
UNII-KM2Z91756Z
UNII-OFG5EXG60L
Z2684418685
ZINC1531009
Tentative approvals for RISEDRONATE SODIUM
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial30MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial35MGTABLET;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
Mylan Pharms Inc RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-005 Jun 10, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-002 Nov 30, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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 020835-002 Apr 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ➤ 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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Non-Orange Book US Patents for risedronate sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,535,718 Dosage forms of bisphosphonates ➤ Try a Free Trial
8,409,614 Low dosage forms of risedronate or its salts ➤ Try a Free Trial
6,544,967 Method for inhibiting bone resorption ➤ Try a Free Trial
6,225,294 Method for inhibiting bone resorption ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for risedronate sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
222 Luxembourg ➤ Try a Free Trial 91222, EXPIRES: 20200824
2006 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
2006002,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
364 Luxembourg ➤ Try a Free Trial 91364, EXPIRES: 20200826
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Department of Justice
Fuji
Merck
US Army
Mallinckrodt
Medtronic
Daiichi Sankyo
Harvard Business School

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.