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Last Updated: December 12, 2019

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Ibandronate sodium - Generic Drug Details

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What are the generic drug sources for ibandronate sodium and what is the scope of freedom to operate?

Ibandronate sodium is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in seventeen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibandronate sodium has one hundred and fourteen patent family members in forty countries.

There are sixteen drug master file entries for ibandronate sodium. Thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for ibandronate sodium

See drug prices for ibandronate sodium

Recent Clinical Trials for ibandronate sodium

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1
Southwest Oncology GroupPhase 3
National Cancer Institute (NCI)Phase 3

See all ibandronate sodium clinical trials

Recent Litigation for ibandronate sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
HOFFMANN-LA ROCHE INC. v. ORCHID CHEMICALS & PHARMACEUTICALS LTD.2010-09-03
Procter & Gamble Company v. Apotex Inc.2009-03-04
Warner Chilcott Company v. Teva Pharmaceuticals USA Inc.2008-09-26

See all ibandronate sodium litigation

Generic filers with tentative approvals for IBANDRONATE SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MGTABLET; ORAL
  Start Trial  Start Trial1MGINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ibandronate sodium
Drug ClassBisphosphonate
Synonyms for ibandronate sodium
(1-Hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonic acid
(1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonic acid sodium
(1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonic acid sodium hydrate
(1-Hydroxy-3-(methylpentylamino)propylidene)diphosphonic acid
[1 -Hydroxy-3-(methylpentylamino)-propylidene]bisphosphonic acid sodium salt
[1-HYDROXY-3-(METHYL-PENTYL-AMINO)-1-PHOSPHONO-PROPYL]-PHOSPHONIC ACID
[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphonic acid
[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphonic acid
{1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl}phosphonic acid
{1-hydroxy-3-[methyl(pentyl)amino]propane-1,1-diyl}bis(phosphonic acid)
084I785
1-hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyldiphosphonic acid
1-hydroxy-3-(methylpentylamino)propylidene bisphosphonic acid
114084-78-5
138844-81-2
138926-19-9
23Y0B94E49
2467AH
AB0005104
AB01275485-01
ABP001087
AC-521
AC1L1U21
AC1Q1W18
AC1Q6RN2
Acid ibandronico
ACT05524
ACT05527
AJ-77707
AK546535
AKOS015855723
AKOS015994672
AKOS025392160
AKOS026750153
AN-15797
AN-31778
AN-31785
API0024527
AS-12948
BC219057
BCP13798
BCP22744
BCP9000767
BDBM12577
BFQ
BG0654
Bisphosphonate 2
BM 21.0955
BM 21.0955 . Na . H2O
BM 21.0955Na
BM 21.0955Na.H2O
BM-21.0955
BM-21.0955 monosodium salt monohydrate
Bondenza
Bondronat
Bondronat (TN)
Boniva
Boniva (TN)
Bonviva
Bonviva (TN)
BRD-K08681769-323-01-1
C9H22NO7P2.Na
C9H23NO7P2
C9H24NNaO8P2
CAS-138844-81-2
CCG-213317
CCG-220679
CCG-222407
CHEMBL1201008
CHEMBL3989569
CHEMBL997
CS-2725
CS-2726
CS-2727
CTK8E7876
CTK8E7877
CTK8E7878
D04486
D08056
DB00710
Destara
DSSTox_CID_26618
DSSTox_GSID_46618
DSSTox_RID_81770
DTXSID5048340
DTXSID8046618
EBD2156407
FT-0602640
FT-0627172
GTPL3059
H487
HMS2090A13
HMS3263M08
HMS3714G19
HY-B0515
HY-B0515A
HY-B0515B
Hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinic acid sodium salt monohydrate
I14-0821
Ibandronate
Ibandronate (Sodium Monohydrate)
Ibandronate (Sodium)
Ibandronate sodium (USAN)
Ibandronate sodium [USAN:JAN]
Ibandronate sodium hydrate
Ibandronate sodium hydrate (JAN)
Ibandronate sodium monohydrate
Ibandronate sodium salt
Ibandronate sodium salt monohydrate
Ibandronate sodium salt, >=97% (NMR), solid
Ibandronic Acid
Ibandronic acid (INN)
Ibandronic acid [INN:BAN]
Ibandronic acid monosodium salt monohydrate
Ibandronic Acid Sodium Salt
J-003052
J-007183
J-007198
J12U072QL0
JMC515594 Compound 53
K-4496
KB-205162
KS-00000IT5
KS-000013JD
KS-1071
LP01103
LS-183991
LS-186539
LS-187361
LXLBEOAZMZAZND-UHFFFAOYSA-M
M-1207
MFCD07197214
MolPort-023-219-579
MolPort-023-222-355
Monosodium [1-hydroxy-3-(methylpentylamino)propane-1,1-diyl]diphosphonate monohydrate
MPBVHIBUJCELCL-UHFFFAOYSA-N
NCGC00167428-01
NCGC00261788-01
Phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-
Phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-, monosodium salt
Phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-, monosodium salt, monohydrate
Phosphonic acid, [1-hydroxy-3-(methylpentylamino)propylidene]bis-
Phosphonic acid, P,P'-[1-hydroxy-3-(methylpentylamino)propylidene]bis-
Phosphonic acid, P,P'-[1-hydroxy-3-(methylpentylamino)propylidene]bis-, sodium salt (1:1)
R-484
R484
RG-484
Ro-200-5450
RPR-102289A
RT-013305
RT-013306
RTC-020914
S0877
SC-17206
SCHEMBL1030768
SCHEMBL1120210
SCHEMBL9183
sodium hydrate hydrogen {1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl}phosphonate
sodium hydrogen (1-hydroxy-3-(methyl(pentyl)amino)-1-phosphonopropyl)phosphonate
sodium hydrogen (1-hydroxy-3-(methyl(pentyl)amino)-1-phosphonopropyl)phosphonate hydrate
sodium hydrogen-1-hydroxy-3-(methyl(pentyl)amino)-1-phosphonopropylphosphonate hydrate
sodium hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphinate
sodium hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphinate hydrate
Sodium Ibandronate
Sodium Trihydrogen (1-Hydroxy-3-(methylpenthylamino)propylidene)diphosphonate Monohydrate
Sodium trihydrogen (1-hydroxy-3-(methylpentylamino)propylidene)diphosphonate, monohydrate
sodium;hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate;hydrate
SodiumIbandronate
SR-05000001496
SR-05000001496-1
SR-05000001496-2
ST24026059
TC-020914
TL8000885
Tox21_112432
Tox21_501103
UMD7G2653W
UNII-23Y0B94E49
UNII-J12U072QL0
UNII-UMD7G2653W
Z2181651281
ZINC1533877
Paragraph IV (Patent) Challenges for IBANDRONATE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
BONIVA INJECTABLE;INTRAVENOUS ibandronate sodium 021858 2007-08-31
BONIVA TABLET;ORAL ibandronate sodium 021455 2007-05-16

US Patents and Regulatory Information for ibandronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202671-001 Sep 2, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 206058-001 Feb 5, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Apotex Inc IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 204222-001 Oct 16, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes   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 ibandronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005   Start Trial   Start Trial
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Harvard Business School
Colorcon
Dow
McKesson

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.