Ibandronate sodium - Generic Drug Details

What are the generic sources for ibandronate sodium and what is the scope of patent protection?

Ibandronate sodium is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Avet Lifesciences, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Norvium Bioscience, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for ibandronate sodium. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ibandronate sodium

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	237
Clinical Trials:	8
Patent Applications:	101
Drug Prices:	Drug price trends for ibandronate sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ibandronate sodium
What excipients (inactive ingredients) are in ibandronate sodium?	ibandronate sodium excipients list
DailyMed Link:	ibandronate sodium at DailyMed

See drug prices for ibandronate sodium

Recent Clinical Trials for ibandronate sodium

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

Sponsor	Phase
Southwest Oncology Group
National Cancer Institute (NCI)
Dr. Reddy's Laboratories Limited	Phase 1

See all ibandronate sodium clinical trials

Generic filers with tentative approvals for IBANDRONATE SODIUM

Applicant	Application No.	Strength	Dosage Form
		2.5MG	TABLET; ORAL
		1MG	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ibandronate sodium

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for IBANDRONATE SODIUM

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 ibandronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sagent Pharms Inc	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	202235-001	Sep 2, 2014	AP	RX	No	No
Dr Reddys Labs Ltd	IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	078997-001	Apr 30, 2012	AB	RX	No	Yes
Aurobindo Pharma	IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	204502-001	Mar 11, 2016	AB	RX	No	No
Apotex	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	204222-001	Oct 16, 2015	AP	RX	No	Yes
Sun Pharm	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	090853-001	Feb 14, 2014		DISCN	No	No
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003		DISCN	Yes	No
Avet Lifesciences	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	203987-001	Sep 2, 2014		DISCN	No	No

Expired US Patents for ibandronate sodium

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
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
Roche	BONIVA	ibandronate sodium	INJECTABLE;INTRAVENOUS	021858-001	Jan 6, 2006
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

Ibandronate sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ibandronate Sodium

Introduction to Ibandronate Sodium

Ibandronate sodium, marketed under the brand name Boniva, is a bisphosphonate used for the treatment and prevention of postmenopausal osteoporosis. It works by increasing bone mineral density (BMD) and reducing the incidence of vertebral fractures.

Market Size and Growth

The global ibandronate sodium market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 1.2 billion and is projected to grow to around USD 2.1 billion by 2032. This growth is driven by the increasing prevalence of osteoporosis, particularly among postmenopausal women, and the expanding demand for effective treatments[1].

Indications and Usage

Ibandronate sodium is indicated for the treatment and prevention of osteoporosis in postmenopausal women. It is available in various formulations, including daily oral tablets (2.5 mg), once-monthly oral tablets (150 mg), and an intravenous (IV) injection administered once every three months (3 mg)[2][3].

Formulations and Their Impact on Market Dynamics

Daily and Once-Monthly Oral Tablets

The daily and once-monthly oral tablets have been widely used due to their ease of administration and patient compliance. The once-monthly formulation, in particular, has been popular as it simplifies the dosing regimen, making it more convenient for patients compared to daily dosing[2][3].

Intravenous (IV) Injection

The approval of the IV injection formulation has provided an alternative for patients who have difficulty with oral bisphosphonate dosing requirements. This includes patients who cannot sit upright for 30 to 60 minutes or swallow a pill. The IV injection is administered by healthcare professionals, ensuring better compliance and monitoring[3].

Clinical Trial Results and Efficacy

Clinical trials, such as the DIVA study, have shown that ibandronate sodium significantly reduces the risk of new vertebral fractures and increases BMD in postmenopausal women. The IV injection formulation has demonstrated superior BMD increases in the lumbar spine, total hip, and other skeletal sites compared to the daily oral tablets[3].

Safety and Tolerability

The safety and tolerability profiles of ibandronate sodium are generally favorable. Common adverse events include back pain, arthralgia, abdominal pain, and dyspepsia. Acute phase reaction-like events have been reported, particularly after the first IV injection, but these are usually mild and transient[2][3].

Market Competition and Pricing

Ibandronate sodium competes in a market dominated by other bisphosphonates, such as alendronate (Fosamax). The cost of ibandronate is approximately $78 per month for either the daily or once-monthly dosage, which is comparable to other treatments like weekly alendronate ($77 per month)[5].

Regulatory Environment

The FDA approval of ibandronate sodium in various formulations has been a significant factor in its market success. The approval of the IV injection in 2006 marked a milestone, providing a new treatment option for patients with postmenopausal osteoporosis[3].

Patient Compliance and Healthcare Professional Influence

Patient compliance is a crucial factor in the market dynamics of ibandronate sodium. The IV injection formulation, administered by healthcare professionals, ensures better compliance and monitoring. This has been particularly beneficial for patients who struggle with oral dosing regimens[3].

Public Health Impact

Osteoporosis is a major public health threat, affecting millions of people worldwide. The availability of effective treatments like ibandronate sodium has been welcomed by healthcare professionals and patient advocacy groups. According to Judith Cranford, Executive Director of the National Osteoporosis Foundation, "Osteoporosis is a serious, widespread and growing public health threat. We welcome any new treatment options such as Boniva Injection that will help patients address this all too prevalent disease"[3].

Financial Trajectory

The financial trajectory of ibandronate sodium is positive, driven by its growing market size and increasing demand. The projected growth to USD 2.1 billion by 2032 indicates a robust financial outlook for this drug. This growth is supported by the expanding patient base and the need for effective osteoporosis treatments[1].

Key Takeaways

• Market Growth: The global ibandronate sodium market is projected to grow significantly, reaching USD 2.1 billion by 2032.
• Formulations: Available in daily, once-monthly oral tablets, and IV injection, catering to different patient needs.
• Efficacy: Clinically proven to reduce vertebral fractures and increase BMD.
• Safety: Generally well-tolerated with common adverse events manageable.
• Competition: Competes with other bisphosphonates but offers unique formulations.
• Regulatory Approval: FDA-approved formulations enhance market credibility.
• Public Health Impact: Addresses a significant public health threat, osteoporosis.

FAQs

What is ibandronate sodium used for?

Ibandronate sodium is used for the treatment and prevention of postmenopausal osteoporosis, increasing bone mineral density and reducing the incidence of vertebral fractures[2].

What are the different formulations of ibandronate sodium?

Ibandronate sodium is available in daily oral tablets (2.5 mg), once-monthly oral tablets (150 mg), and an intravenous (IV) injection administered once every three months (3 mg)[2][3].

How does the IV injection formulation benefit patients?

The IV injection formulation benefits patients who have difficulty with oral bisphosphonate dosing requirements, ensuring better compliance and monitoring by healthcare professionals[3].

What are the common adverse events associated with ibandronate sodium?

Common adverse events include back pain, arthralgia, abdominal pain, and dyspepsia. Acute phase reaction-like events can occur, particularly after the first IV injection[2][3].

How does the cost of ibandronate sodium compare to other treatments?

The cost of ibandronate sodium is approximately $78 per month, which is comparable to other bisphosphonate treatments like weekly alendronate ($77 per month)[5].

Cited Sources:

1. Dataintelo: Global Ibandronate Sodium Market Research Report 2032.
2. Drugs.com: Ibandronate Sodium Tablets: Package Insert / Prescribing Info.
3. Biospace: Roche Approves First IV Treatment For Postmenopausal Osteoporosis.
4. Cognitivemarketresearch: Global Ibandronate Sodium Market Report 2024 Edition.
5. American Academy of Family Physicians: Ibandronate (Boniva) for Treatment and Prevention of Osteoporosis.