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Last Updated: April 9, 2025

IBANDRONATE SODIUM Drug Patent Profile


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Which patents cover Ibandronate Sodium, and when can generic versions of Ibandronate Sodium launch?

Ibandronate Sodium is a drug marketed by Accord Hlthcare, Apotex, Avet Lifesciences, Chemi Spa, Eugia Pharma, Nang Kuang Pharm Co, Norvium Bioscience, Sun Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva. and is included in sixteen NDAs.

The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ibandronate Sodium

A generic version of IBANDRONATE SODIUM was approved as ibandronate sodium by APOTEX INC on March 19th, 2012.

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Recent Clinical Trials for IBANDRONATE SODIUM

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SponsorPhase
Southwest Oncology Group
National Cancer Institute (NCI)
Dr. Reddy's Laboratories LimitedPhase 1

See all IBANDRONATE SODIUM clinical trials

Pharmacology for IBANDRONATE SODIUM
Drug ClassBisphosphonate
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Orbion Pharms IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078998-001 Mar 19, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs Teva IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 079003-001 Mar 20, 2012 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 090853-001 Feb 14, 2014 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chemi Spa IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202235-001 Sep 2, 2014 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Norvium Bioscience IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202671-001 Sep 2, 2014 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Accord Hlthcare IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 206058-001 Feb 5, 2016 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Macleods Pharms Ltd IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 206887-001 Oct 31, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

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.

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