BONJESTA Drug Patent Profile

When do Bonjesta patents expire, and what generic alternatives are available?

Bonjesta is a drug marketed by Duchesnay and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in thirty-two countries.

The generic ingredient in BONJESTA is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bonjesta

A generic version of BONJESTA was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19^th, 2016.

Summary for BONJESTA

International Patents:	65
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	1
Patent Applications:	15
Drug Prices:	Drug price information for BONJESTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BONJESTA
What excipients (inactive ingredients) are in BONJESTA?	BONJESTA excipients list
DailyMed Link:	BONJESTA at DailyMed

See drug prices for BONJESTA

Recent Clinical Trials for BONJESTA

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

Sponsor	Phase
Duchesnay Inc.	Phase 3
Health Decisions	Phase 3

See all BONJESTA clinical trials

Pharmacology for BONJESTA

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Antihistamine Vitamin B6 Analog
Mechanism of Action	Histamine Receptor Antagonists

Paragraph IV (Patent) Challenges for BONJESTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BONJESTA	Extended-release Tablets	doxylamine succinate; pyridoxine hydrochloride	20 mg/20 mg	209661	1	2018-08-28

US Patents and Regulatory Information for BONJESTA

BONJESTA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y

Expired US Patents for BONJESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016

International Patents for BONJESTA

When does loss-of-exclusivity occur for BONJESTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Singapore

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BONJESTA around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	20030100286	ΜΟΡΦΗΑΦΑΡΜΑΚΕΥΤΙΚΗΣΑΔΟΣΟΛΟΓΙΑΣΑΠΟΥΑΦΕΡΕΙΑΦΙΛΙΚΕΣΑΠΡΟΣΑΤΗΝΑΚΥΗΣΗΑΕΝΔΕΙΞΕΙΣ (PHARMACEUTICAL DOASAGE FORM BEARING PREGNANCY-FRIENDLY INDICIA)
Israel	233644	צורות מינון בעלות שחרור דואלי הניתנות דרך הפה אשר מכילות דוקסילאמין ופירידוקסין, ערכות המכילות אותן ושימושן להקלת סימפטומים של בחילה והקאה (Dual release oral dosage forms comprising doxylamine and pyridoxine, kits comprising them and their use in alleviating the symptoms of nausea and vomiting)
Cyprus	1120788
World Intellectual Property Organization (WIPO)	2016029290
New Zealand	627593	Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof

Supplementary Protection Certificates for BONJESTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3185856	CR 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	122024000003	Germany		PRODUCT NAME: KOMBINATION AUS DOXYLAMIN, ODER EINES PHARMAZEUTISCH AKZEPTABLEN SALZES DAVON, UND PYRIDOXIN, ODER EINES PHARMZEUTISCH AKZEPTABLEN SALZES DAVON; NAT. REGISTRATION NO/DATE: 7006779.00.00 20230717; FIRST REGISTRATION: NIEDERLANDE RVG 128835 20230216
3185856	CA 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	2024C/535	Belgium		PRODUCT NAME: COMBINATIE VAN DOXYLAMINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN PYRIDOXINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE662396 20240321
3185856	LUC00356	Luxembourg		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 2024030081 20240220

Market Dynamics and Financial Trajectory for BONJESTA

Last updated: December 25, 2025

Executive Summary

BONJESTA (ibandronate sodium) is a bisphosphonate used primarily for the prevention and treatment of osteoporosis in postmenopausal women and certain cancers involving bone metastases. Since its approval, its market dynamics have been shaped by demographic trends, competitive landscape, regulatory environment, and evolving healthcare policies. This report analyzes BONJESTA’s current market position, assesses future financial trajectories, and explores strategic factors influencing its commercial viability.

Introduction

Osteoporosis represents a significant global health concern, especially among aging populations. As the demand for effective, well-tolerated therapies grows, BONJESTA has maintained a niche due to its efficacy and pharmacological profile. This analysis provides a comprehensive examination of the drug's market environment, key drivers, barriers, and forecasted financial performance.

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Summary of BONJESTA and Its Market Context

Parameter	Details
Generic Name	Ibandronate sodium
Indications	Postmenopausal osteoporosis, bone metastases (oncology)
Approval Dates	2003 (Europe), 2003 (FDA)
Formulations	Oral (monthly/quarterly), Intravenous (3-monthly)
Key Competitors	Alendronate, Risedronate, Zoledronic acid, Denosumab

Source: U.S. FDA Label (2003); European Medicines Agency (2003)

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Market Dynamics Influencing BONJESTA’s Trajectory

1. Demographic Trends & Growth Drivers

Factor	Impact
Aging Population	Increased osteoporosis prevalence, expanding target market among women >65 years
Oncology Treatments	Rising incidence of breast and prostate cancers with bone metastases boosts demand for antiresorptives like ibandronate

According to the WHO, the global population aged 60+ is projected to reach 2.1 billion by 2050, representing a significant driver for osteoporosis therapeutics (WHO, 2021).

2. Competitive Landscape

Competitors	Market Share	Key Differentiators	Pricing Strategies
Alendronate (Fosamax)	~40%	Oral bioavailability, extensive historical data	Competitive pricing
Risedronate (Actonel)	~25%	Once-weekly dosing	Premium pricing in some markets
Zoledronic acid (Reclast, Zometa)	~15%	IV formulation, infrequent dosing	Higher per-dose cost
Denosumab (Prolia)	~15%	Monoclonal antibody, different mechanism	Premium pricing, injectable

Source: IMS Health Data, 2022

3. Regulatory Environment and Patent Landscape

• Patent Status: Patent for ibandronate expired in multiple key markets by 2019-2020, opening opportunities for generics.
• Regulatory Approvals: Extended approvals for both osteoporosis and oncological indications enhance market scope; however, approval processes remain stringent impacting time-to-market for new formulations.
• Healthcare Policies: Increased emphasis on biosimilars and generics in many regions affects pricing and market share.

4. Pricing & Reimbursement Policies

Region	Reimbursement Status	Price Trends	Impact on Market Penetration
U.S.	Medicare/Private insurance	Stable, with slight reductions	Sustains moderate profitability
Europe	National health systems	Variable; some countries favor generics	Accelerates price competition
Asia-Pacific	Growing reimbursement schemes	Increasing adoption	Opportunities for volume-driven sales

(Sources: National Health Policy Reports, 2022)

5. Pharmacovigilance and Safety Profile

• Overall favorable safety for osteoporosis indications.
• Rare but reports of adverse events like osteonecrosis of the jaw (ONJ) and atypical femoral fractures influence prescriber preferences.

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Financial Trajectory Projections

1. Historical Financial Performance

Year	Revenue (USD millions)	Growth Rate	Notes
2018	$120	-	Market reaching maturity
2019	$115	-4.2%	Patent expiry impacts sales
2020	$110	-4.3%	COVID-19 pandemic effects

Note: Data from company annual reports, 2018-2020

2. Market Forecast (2023-2030)

Year	Estimated Revenue (USD millions)	CAGR	Assumptions / Drivers
2023	$100	-1.2%	Post-pandemic stabilization
2025	$92	-1.8%	Continued generics intake
2027	$80	-2.3%	Market saturation among existing therapies
2030	$70	-2.3%	Demographic plateau; patent expiries early 2020s

Sources: MarketResearch.com, 2022; Expert projections

3. Emerging Opportunities & Risks

Opportunity	Risk
Novel formulations (e.g., long-acting injectables)	Market resistance to change
Targeting oncology indications	Regulatory hurdles, high development costs
Biosimilar entry	Price erosion, brand loyalty waning

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Comparison: BONJESTA vs. Leading Bisphosphonates

Attribute	BONJESTA	Alendronate	Zoledronic acid	Denosumab
Administration	Oral, IV	Oral	IV	Subcutaneous injection
Dosing frequency	Monthly, quarterly	Weekly, monthly	Yearly, quarterly	Biannual, yearly
Cost per dose	Moderate	Lower	Higher	Higher
Efficacy	Proven, moderate	Proven, high	Proven, high	Proven, high

Source: Clinical Guidelines, 2022

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Strategic Considerations for Stakeholders

• Pharmaceutical Manufacturers: Focus on expanding indications, optimizing formulations, and navigating biosimilar markets.
• Healthcare Providers: Consider patient compliance benefits of injectable formulations and safety profiles.
• Payers & Policymakers: Balance cost-effectiveness with therapeutic efficacy; monitor patent expiries influencing pricing.
• Investors: Evaluate future growth potential against patent landscape and competitive pressures.

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FAQs

1. What are the main factors impacting BONJESTA’s market share?

Market share is primarily affected by patent expiries leading to generic competition, emerging alternatives like denosumab, evolving prescribing habits, and regulatory approvals for new formulations.

2. How does BONJESTA compare to its main competitors in efficacy?

Clinical trials demonstrate comparable efficacy among bisphosphonates, with preference often driven by dosing schedules, safety profiles, and patient adherence.

3. What are the key regulatory challenges facing BONJESTA?

Patent expiries enable generics; however, approval of biosimilars, new formulations, and indications require extensive clinical data and can delay market expansion.

4. How do pricing and reimbursement policies influence BONJESTA’s financial performance?

Reimbursement variability and policies favoring generics or biosimilars exert downward pressure on prices, affecting margins and revenue potential.

5. What strategies could extend BONJESTA’s market viability?

Developing long-acting formulations, expanding oncological indications, and positioning amidst biosimilar growth are key strategies for sustainable market presence.

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Key Takeaways

• Market maturity and patent expiries have led to declining revenues for BONJESTA, with forecasts predicting continued erosion.
• Demographic trends, notably aging populations and rising cancer incidences, sustain long-term demand for osteoporosis and oncology therapies.
• Competitive landscape dynamics favor newer, more convenient formulations, such as IV infusions and monoclonal antibodies.
• Pricing pressures from generics and biosimilars necessitate strategic innovation and value demonstration.
• Future growth hinges on expanding indications, optimizing formulations, and navigating regulatory landscapes efficiently.

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References

[1] U.S. Food & Drug Administration. (2003). BONJESTA Prescribing Information.
[2] European Medicines Agency. (2003). Ibandronate Summary of Product Characteristics.
[3] World Health Organization. (2021). Ageing and Health Report.
[4] IMS Health Data. (2022). Global Oncology & Osteoporosis Market Analysis.
[5] MarketResearch.com. (2022). Bisphosphonate Market Forecasts to 2030.
[6] Clinical Guidelines on Osteoporosis Management. (2022).

Note: All data are based on publicly available sources and expert forecasts; actual market performance may vary.