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Last Updated: January 3, 2025

BONIVA Drug Patent Profile


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Which patents cover Boniva, and what generic alternatives are available?

Boniva is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs.

The generic ingredient in BONIVA 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 Boniva

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

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Drug patent expirations by year for BONIVA
Drug Prices for BONIVA

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Drug Sales Revenue Trends for BONIVA

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Recent Clinical Trials for BONIVA

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SponsorPhase
Hoffmann-La RochePhase 3
Hoffmann-La Roche
M.D. Anderson Cancer CenterPhase 3

See all BONIVA clinical trials

Paragraph IV (Patent) Challenges for BONIVA
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 BONIVA

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 3 of 3 entries

Expired US Patents for BONIVA

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ⤷  Subscribe ⤷  Subscribe
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

International Patents for BONIVA

See the table below for patents covering BONIVA around the world.

CountryPatent NumberTitleEstimated Expiration
Brazil 9914367 ⤷  Subscribe
Canada 2763775 ACIDE BISPHOSPHONIQUE POUR LE TRAITEMENT ET LA PREVENTION DE L'OSTEOPOROSE (BISPHOSPHONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTEOPOROSIS) ⤷  Subscribe
German Democratic Republic 263992 NEUE DIPHOSPHONSAEUREDERIVATE, VERFAHREN ZU DEREN HERSTELLUNG UND DIESE VERBINDUNGEN ENTHALTENDE ARZNEIMITTEL ⤷  Subscribe
Israel 83149 1-HYDROXY-3-(N-METHYL-N-PROPYLAMINO)PROPANE-1,1-DIPHOSPHONIC ACID,PROCESSES FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for BONIVA

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0252504 96C0046 Belgium ⤷  Subscribe PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
0252504 C960032 Netherlands ⤷  Subscribe PRODUCT NAME: ACIDUM IBANDRONICUM, DESGEWENST IN DE VORM VAN EEN FARMACOLO- GISCH AANVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET METHANOL,ETHANOL,2-PROPANOL OF 2-METHYLPROPANOL, OF IN DE VORM VEN EEN HYDRAAT,I.H.B.MONONATRIUM IBANDRONAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
0252504 SPC/GB96/060 United Kingdom ⤷  Subscribe PRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries

BONIVA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: Boniva

Introduction

Boniva, known generically as ibandronate sodium, is a significant player in the osteoporosis drugs market, particularly within the bisphosphonate class. This article delves into the market dynamics and financial trajectory of Boniva, highlighting its historical performance, current market position, and future prospects.

Historical Approval and Market Entry

Boniva was first approved by the FDA in 2003 as a daily oral tablet for the treatment and prevention of postmenopausal osteoporosis. It later received approval for a once-monthly oral tablet in March 2005 and subsequently for an intravenous (IV) injection in January 2006[3].

Market Share and Competition

In the early 2000s, Boniva was one of the leading drugs in the osteoporosis market, along with other bisphosphonates like Fosamax and Actonel. However, its market share has fluctuated over the years due to various factors. By 2010, Boniva and Evista were among the top drugs in the market, but the introduction of Prolia in 2011 significantly altered the market dynamics. Prolia eventually dominated the market, capturing nearly 45% of the share by 2015, while Boniva's share declined[4].

Sales Performance

Boniva's sales have seen a mixed trend. From 2005 to 2010, Boniva's sales were substantial, but they began to decline as generic and biosimilar competition increased. The global sales of Boniva peaked in the mid-2000s but dropped significantly by 2015 due to patent expiry and competition from cheaper generics[4].

Clinical Significance and Patient Compliance

Boniva's IV injection formulation, approved in 2006, provided an alternative for patients who had difficulty with oral bisphosphonate dosing requirements. This formulation improved patient compliance, as it was administered by healthcare professionals once every three months. Clinical trials, such as the DIVA study, demonstrated that Boniva Injection was non-inferior to the daily oral formulation and even showed superior bone mineral density (BMD) increases in some skeletal sites[3].

Safety and Tolerability

The safety profile of Boniva is generally consistent with other bisphosphonates. Common adverse events include arthralgia, back pain, and acute phase reaction-like events, particularly after the first injection. However, these events are typically mild and transient[3].

Market Size and Growth Projections

The global osteoporosis drugs market, within which Boniva operates, is projected to grow from USD 8.9 billion in 2022 to USD 12.12 billion by 2031, at a CAGR of 3.5% during the forecast period. The bisphosphonates segment, which includes Boniva, dominates this market but is expected to grow at a slower CAGR of 1.1% due to safety concerns and competition from newer drugs[1].

Regional Market Dynamics

North America and Europe are the dominant regions for osteoporosis drugs, including Boniva. However, these markets are saturated, leading to slower growth rates. Emerging markets in Asia-Pacific and Latin America, Middle East, and Africa (LAMEA) are expected to offer better growth opportunities. Countries like Brazil, Japan, India, and China are becoming more aware of their healthcare needs and are investing in advanced drug delivery systems, which could benefit Boniva's market presence[1].

Financial Performance of Key Players

Roche, one of the major players in the osteoporosis market and the manufacturer of Boniva, has seen mixed financial results in recent years. While the Pharmaceuticals Division has shown growth driven by demand for other drugs like Vabysmo and Ocrevus, the impact of biosimilar competition on older drugs like Boniva has been significant. In 2022, Roche's Pharmaceuticals Division sales increased by 6% at constant exchange rates, but the decline in sales of older drugs due to biosimilar competition was a notable factor[2].

Future Prospects

The future prospects for Boniva are influenced by several factors, including the increasing prevalence of osteoporosis, especially in postmenopausal women, and the need for alternative dosing formulations. However, the drug faces significant competition from newer treatments and biosimilars. The market's shift towards more innovative and safer treatments may further challenge Boniva's market share.

Key Takeaways

  • Market Position: Boniva is a significant player in the bisphosphonate segment of the osteoporosis drugs market but faces declining market share due to competition.
  • Clinical Significance: Boniva's IV injection formulation has improved patient compliance and shown favorable clinical outcomes.
  • Safety Profile: The drug has a generally safe profile, though it shares common adverse events with other bisphosphonates.
  • Market Growth: The global osteoporosis drugs market is growing, but the bisphosphonates segment is expected to grow at a slower rate.
  • Regional Dynamics: Emerging markets offer better growth opportunities, while saturated markets in North America and Europe show slower growth.

FAQs

What is Boniva used for?

Boniva (ibandronate sodium) is used for the treatment and prevention of postmenopausal osteoporosis.

What are the different formulations of Boniva?

Boniva is available in daily and once-monthly oral tablet formulations, as well as an intravenous (IV) injection given once every three months.

How does Boniva compare to other bisphosphonates in terms of market share?

Boniva was once a leading drug in the osteoporosis market but has seen its market share decline due to competition from newer drugs like Prolia and generic/biosimilar alternatives.

What are the common adverse events associated with Boniva?

Common adverse events include arthralgia, back pain, and acute phase reaction-like events, particularly after the first injection.

How is the global osteoporosis drugs market expected to grow?

The global osteoporosis drugs market is projected to grow from USD 8.9 billion in 2022 to USD 12.12 billion by 2031, at a CAGR of 3.5%.

Sources

  1. Straits Research: Osteoporosis Drugs Market Size to Reach $12.12 billion by 2031.
  2. Roche: Finance Report 2023.
  3. Biospace: Roche Approves First IV Treatment For Postmenopausal Osteoporosis.
  4. Renub Research: Global Osteoporosis Market & Drugs Analysis 2010 - 2015.
  5. Roche: Finance Report 2022.

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