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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Baxter
Moodys
UBS
Cantor Fitzgerald
Teva
Queensland Health
Argus Health

Generated: June 25, 2018

DrugPatentWatch Database Preview

BONIVA Drug Profile

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When do Boniva patents expire, and when can generic versions of Boniva launch?

Boniva is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fourteen patent family members in forty countries.

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Drug patent expirations by year for BONIVA
Pharmacology for BONIVA
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Synonyms for BONIVA
(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 (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
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

US Patents and Regulatory Information for BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ 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 BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BONIVA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 1 mg/mL, 3 mL Vial ➤ Subscribe 2007-08-31
➤ Subscribe Tablets 2.5 mg and 150 mg ➤ Subscribe 2007-05-16

Premature patent expiration for: BONIVA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Sign Up BONIVA ➤ Sign Up

Non-Orange Book US Patents for BONIVA

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:

UBS
Boehringer Ingelheim
US Army
Express Scripts
QuintilesIMS
Covington
Chubb
Cerilliant
Johnson and Johnson

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.