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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 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. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ibandronate sodium

International Patents:	114
US Patents:	4
Tradenames:	2
Applicants:	15
NDAs:	17
Drug Master File Entries:	16
Suppliers / Packagers:	15
Bulk Api Vendors:	146
Clinical Trials:	4
Patent Applications:	6,888
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ibandronate sodium
DailyMed Link:	ibandronate sodium at DailyMed

Pharmacology for ibandronate sodium

Ingredient-type	Diphosphonates
Drug Class	Bisphosphonate

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
		2.5MG	TABLET; ORAL
		1MG	INJECTABLE; 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
Dr Reddys Labs Ltd	IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	078997-001	Apr 30, 2012	AB	RX	No	No
Sun Pharm Industries	IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	078996-001	Aug 15, 2012	AB	RX	No	No
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	AB	RX	Yes	Yes			Y
Watson Labs Teva	IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	079003-001	Mar 20, 2012	AB	RX	No	No

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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	021455-001	May 16, 2003
Roche	BONIVA	ibandronate sodium	INJECTABLE;INTRAVENOUS	021858-001	Jan 6, 2006
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003

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

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International Patents for ibandronate sodium

Country	Document Number	Estimated Expiration
Peru	04402004
Argentina	061845
Croatia	P20040906
Hong Kong	1080409