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BONIVA

NDA

IBANDRONATE SODIUM | N021455 | HOFFMANN LA ROCHE INC

2 strengths0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
HOFFMANN-LA ROCHE INC. v. WATSON LABORATORIES, INC. et al 2:2010cv06206 6 patentsANDA 79002, 79003Ibandronic acid (Ibandronate Sodium)	D.N.J.	2010-11-29	Terminated 2011-02-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions 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	—
Watson Laboratories, Inc. - Citizen Petition FDA-2010-P-0116 · 3 docket documents Watson Laboratories, Inc. filed this petition on February 24, 2010, requesting that the FDA determine whether Roche Therapeutics' BONIVA (ibandronate sodium) Tablets, 2.5 mg (NDA 021455) was voluntarily withdrawn from sale for safety or effectiveness reasons, and if not, to declare that abbreviated	505(q)	2010-03-03	Withdrawn	—

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.

Medicare Part B Spending

CMS physician-administered drug spending for Boniva (2024)

Total Spending

$122K

Total Claims

1,505

Beneficiaries

616

ASP Price

$28.29

Spending Trend

$1.0M(2019)→$630K(2020)→$453K(2021)→$229K(2022)→$268K(2023)→$122K(2024)

YoY Change:-5.2%

5yr CAGR:-10.6%

HCPCS: J1740 — Injection, ibandronate sodium, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

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

14 letters from Drugs@FDA

Date	Submission	Document
Dec 8, 2016	SUPPL -21	View Letter (PDF)
Apr 13, 2015	SUPPL -20	View Letter (PDF)
Mar 19, 2015	SUPPL -19	View Letter (PDF)
Dec 18, 2014	SUPPL -18	View Letter (PDF)
Apr 24, 2013	SUPPL -15	View Letter (PDF)
Apr 24, 2013	SUPPL -14	View Letter (PDF)
Jul 6, 2011	SUPPL -13	View Letter (PDF)
Feb 2, 2011	SUPPL -11	View Letter (PDF)
Jan 15, 2010	SUPPL -9	View Letter (PDF)
Nov 28, 2008	SUPPL -7	View Letter (PDF)
Feb 23, 2007	SUPPL -5	View Letter (PDF)
Jun 20, 2006	SUPPL -3	View Letter (PDF)
Mar 28, 2005	SUPPL -1	View Letter (PDF)
Jun 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 16, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 24, 2005