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BONIVA

NDA

IBANDRONATE SODIUM | N021858 | HOFFMANN LA ROCHE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Hoffmann-La Roche, Inc., (Pharmaceutical Law Group PC) - Citizen Petition FDA-2010-P-0518 · 11 docket documents Hoffmann-La Roche Inc. filed this citizen petition requesting that the FDA confirm it will impose a 30-month stay on approval of Orchid Healthcare's ANDA No. 78-998 for a generic version of Boniva Once-Monthly, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), starting from July 26, 2010, when Roche receiv	505(q) Stay Request	2010-10-25	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

61 trials from ClinicalTrials.gov, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis NCT02598440	Phase 4	Completed	Hoffmann-La Roche	341	2004-03 → 2005-05
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)NCT00271713	Phase 4	Completed	Charite University, Berlin, Germany	70	2006-03 → 2007-09
Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects NCT00666627	Phase 2	Completed	Sheffield Teaching Hospitals NHS Foundation Trust	410	2007-04 → 2014-12
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.NCT00377234	Phase 4	Completed	Hoffmann-La Roche	356	2006-05 → 2008-08
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.NCT00502736	Phase 2	Completed	Hoffmann-La Roche	13	2008-01 → 2009-03
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.NCT00545480	Phase 4	Completed	Hoffmann-La Roche	596	2006-07 → 2009-03
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis NCT00048074	Phase 3	Completed	Hoffmann-La Roche	1,395	2002-06 → 2005-05
A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer NCT02716792	Phase 3	Completed	Hoffmann-La Roche	334	2006-01 → 2008-08
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.NCT00545090	Phase 4	Completed	Hoffmann-La Roche	561	2006-08 → 2008-06
Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus NCT00668330	Phase 4	Completed	Chinese University of Hong Kong	40	2007-04 → 2009-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

APITORIA PHARMA PRIVATE LTDIBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE)

DMF 203932007

NATCO PHARMA LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 204112007

ORBION PHARMACEUTICALS PRIVATE LTDIBANDRONATE SODIUM

DMF 204222007

DR REDDYS LABORATORIES LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 204662007

APOTEX INCIBANDRONATE SODIUM

DMF 205252007

DR REDDYS LABORATORIES LTDIBANDRONATE SODIUM (FORM-BETA)

DMF 223002008

NATCO PHARMA LTDIBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE)

DMF 248242011

EMCURE PHARMACEUTICALS LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 251722011

ZAKLADY FARMACEUTYCZNE POLPHARMA SAIBANDRONATE SODIUM MONOHYDRATE

DMF 256382011

MACLEODS PHARMACEUTICALS LTDIBANDRONATE SODIUM MONOHYDRATE

DMF 257932012

ROCHE DIAGNOSTICS GMBHInactiveIBANDRONATE, EDITION I

DMF 154292001

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveIBANDRONATE SODIUM

DMF 204942007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jan 12, 2022	SUPPL -23	View Letter (PDF)
Dec 9, 2016	SUPPL -22	View Letter (PDF)
Apr 13, 2015	SUPPL -20	View Letter (PDF)
Mar 19, 2015	SUPPL -19	View Letter (PDF)
Apr 24, 2013	SUPPL -8	View Letter (PDF)
Apr 24, 2013	SUPPL -14	View Letter (PDF)
Apr 24, 2013	SUPPL -13	View Letter (PDF)
Aug 12, 2011	SUPPL -10	View Letter (PDF)
Jul 7, 2011	SUPPL -12	View Letter (PDF)
Jan 27, 2011	SUPPL -9	View Letter (PDF)
Feb 23, 2007	SUPPL -4	View Letter (PDF)
Aug 9, 2006	SUPPL -1	View Letter (PDF)
Jan 10, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Jan 6, 2006

No patent or exclusivity listings for this strength.