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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ibandronate Sodium* (2023)

Total Spending

$34.4M

Total Claims

786,421

Beneficiaries

239,104

Avg Cost/Unit

$17.51

Spending Trend

$738K(2019)→$41.4M(2019)→$649K(2020)→$37.8M(2020)→$555K(2021)→$34.3M(2021)→$38.9M(2022)→$355K(2022)→$21K(2023)→$34.4M(2023)

YoY Change:-20.3%

5yr CAGR:-11.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs1 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

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