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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Daiichi Sankyo
Cerilliant
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Healthtrust

Generated: August 14, 2018

DrugPatentWatch Database Preview

IBANDRONATE SODIUM - Generic Drug Details

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

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, Sun Pharm Inds Ltd, 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. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for IBANDRONATE SODIUM
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Synonyms for IBANDRONATE SODIUM
(1-Hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonic acid
(1-Hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonicacid
(1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonate
(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- -propylidene]bisphosphonicacidsodiumsalt
[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
084I785
1-hydroxy-3-(methylpentylamino)propylidene bisphosphonic acid
1-hydroxy-3-(methylpentylamino)propylidenebisphosphonate
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
AK120881
AKOS015855723
AKOS015994672
AKOS025392160
AKOS026750153
AN-15797
AN-31778
AN-31785
API0024527
AS-12948
BC219057
BCP9000767
BDBM12577
BFQ
BG0654
Bisphosphonate 2
BM 21.0955
BM 21.0955 . Na . H2O
BM 21.0955Na
BM 21.0955Na.H2O
BM 210955
BM-21.0955
BM-21.0955 monosodium salt monohydrate
BM-210955
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
CHEMBL997
CS-2725
CS-2726
CS-2727
CT-064
CTK8E7876
CTK8E7877
CTK8E7878
D04486
D08056
D08SJZ
D0G9FL
DB00710
Destara
DSSTox_CID_26618
DSSTox_GSID_46618
DSSTox_RID_81770
DTXSID5048340
DTXSID8046618
EBD2156407
FT-0602640
FT-0627172
GTPL3059
H487
HMS2090A13
HMS3263M08
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 Na salt
Ibandronic Acid Sodium Salt
ibandronic acid, sodium salt, monohydrate
J-003052
J-007183
J-007198
J12U072QL0
JMC515594 Compound 53
K-4496
KB-205162
KS-00000IT5
KS-000013JD
KS-1071
LP01103
LP058979
LP068287
LP071868
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-
R-484
R484
RG-484
Ro-200-5450
Roche brand of ibandronic acid, sodium salt, monohydrate
RPR 102289A
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 HYDRATE HYDROGEN 1-HYDROXY-3-[METHYL(PENTYL)AMINO]-1-PHOSPHONOPROPYLPHOSPHONATE
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
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
ST24026059
TC-020914
TL8000885
Tox21_112432
Tox21_501103
UMD7G2653W
UNII-23Y0B94E49
UNII-J12U072QL0
UNII-UMD7G2653W
Z2181651281
ZINC1533877
Tentative approvals for IBANDRONATE SODIUM
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up2.5MGTABLET; ORAL
➤ Sign Up➤ Sign Up1MGINJECTABLE; INJECTION

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
Sun Pharm Industries IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078996-001 Aug 15, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 206058-001 Feb 5, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sagent Pharms IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202235-001 Sep 2, 2014 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 205332-001 Aug 19, 2015 AP RX 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 IBANDRONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ➤ Sign Up ➤ Sign Up
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for IBANDRONATE 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
6,627,221 Pharmaceutical composition containing diphosphonic acid or salt thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Dow
Queensland Health
Johnson and Johnson
AstraZeneca
Cantor Fitzgerald
Covington
Boehringer Ingelheim
Deloitte

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.