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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Boniva (2023)

Total Spending

$268K

Total Claims

3,129

Beneficiaries

1,162

ASP Price

—

HCPCS: J1740 — Injection, ibandronate sodium, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

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.