BONIVA Drug Patent Profile

Which patents cover Boniva, and what generic alternatives are available?

Boniva is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs.

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Boniva

A generic version of BONIVA was approved as ibandronate sodium by APOTEX INC on March 19^th, 2012.

Summary for BONIVA

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	13
Patent Applications:	3,787
Drug Prices:	Drug price information for BONIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BONIVA
What excipients (inactive ingredients) are in BONIVA?	BONIVA excipients list
DailyMed Link:	BONIVA at DailyMed

See drug prices for BONIVA

See drug sales revenues for BONIVA

Recent Clinical Trials for BONIVA

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

Sponsor	Phase
Hoffmann-La Roche	Phase 3
Hoffmann-La Roche
M.D. Anderson Cancer Center	Phase 3

See all BONIVA clinical trials

Paragraph IV (Patent) Challenges for BONIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BONIVA	Injection	ibandronate sodium	1 mg/mL, 3 mL Vial	021858	1	2007-08-31
BONIVA	Tablets	ibandronate sodium	2.5 mg	021455	1	2007-05-16

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		DISCN	Yes	No
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003		DISCN	Yes	No
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005		DISCN	Yes	No

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

International Patents for BONIVA

See the table below for patents covering BONIVA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69928819
Cyprus	1116233
European Patent Office	2851105	Acides bisphosphoniques pour le traitement et la prévention d'ostéoporose (Bisphosphonic acids for treatment and prevention of osteoporosis)
Colombia	5050325	COMPOSICIONES QUE CONTIENEN ACIDOS DIFOSFONICOS
China	100551377
Canada	1305166	ACIDE 1-HYDROXY-3-(N-METHYL-N-PROPYLAMINO)PROPANE-1,1- DIPHOSPHONIQUE, COMPOSITIONS PHARMACEUTIQUES ET METHODES D'UTILISATION (1-HYDROXY-3-(N-METHYL-N-PROPLYLAMINO)PROPANE-1,1- DIPHOSPHONIC ACID, PHARMACEUTICAL COMPOSITIONS AND METHODS OF USE)

Supplementary Protection Certificates for BONIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0252504	SPC/GB96/060	United Kingdom		PRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
0252504	C960032	Netherlands		PRODUCT NAME: ACIDUM IBANDRONICUM, DESGEWENST IN DE VORM VAN EEN FARMACOLO- GISCH AANVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET METHANOL,ETHANOL,2-PROPANOL OF 2-METHYLPROPANOL, OF IN DE VORM VEN EEN HYDRAAT,I.H.B.MONONATRIUM IBANDRONAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
0252504	96C0046	Belgium		PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624