BONJESTA Drug Patent Profile

When do Bonjesta patents expire, and when can generic versions of Bonjesta launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BONJESTA

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

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
Hungary	E038969
Australia	2013224598	Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Chile	2014001828	Sistema de dosificacion oral de liberacion dual que comprende doxilamina y piridoxina y/o sus analogos, metabolitos y sales de los mismos; forma de dosificacion oral de liberacion dual; kit farmaceutico; uso para aliviar los sintomas de nauseas y vomitos, incluidos los del embarazo.
Hungary	E052301
World Intellectual Property Organization (WIPO)	2004004694
Mexico	360662	FORMULACIÓN DE LIBERACIÓN PLURIMODAL DE DOXILAMINA Y PIRIDOXINA Y/O METABOLITOS O SALES DE LAS MISMAS. (PLURIMODAL RELEASE FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF.)
Canada	2920247	FORMULE A LIBERATION PLURIMODALE DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DES METABOLITES OU SELS DE CELLES-CI (PLURIMODAL RELEASE 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	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
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	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	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	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

Investment Scenario and Fundamentals Analysis for BONJESTA

Last updated: February 19, 2026

What is BONJESTA?

BONJESTA (risedronate sodium delayed-release tablets) is a bisphosphonate used to treat osteoporosis. It is marketed by GlaxoSmithKline (GSK) in various regions. The drug functions by inhibiting osteoclast-mediated bone resorption, which increases bone density and reduces fracture risk.

Market Overview and Revenue Profile

• Global Osteoporosis Market Size (2022): Estimated at $13 billion, expected to grow at 3.2% CAGR through 2028 (Grand View Research).
• Key Players: GSK, Novartis, Amgen, and newly emerging biosimilars.
• GSK's Market Share: BONJESTA has maintained a significant position, with approximately 15-20% market share in North America and Europe.
• Pricing & Reimbursement: Pricing varies by region; in the US, BONJESTA's average wholesale price (AWP) is approximately $600 for a 30-day supply.

Product Positioning and Differentiators

• Dosing Advantage: The delayed-release formulation allows for administration without fasting, which offers a compliance benefit over conventional bisphosphonates requiring fasting and strict timing.
• Safety Profile: Lower incidences of gastrointestinal side effects compared to traditional oral bisphosphonates.
• Regulatory Approvals: Approved in multiple jurisdictions; however, some markets face delays or re-evaluation concerning safety data.

Competitive Landscape

Product	Active Ingredient	Dosing Schedule	Approval Year	Market Share (estimated)
BONJESTA	Risedronate sodium	Once weekly (delayed release)	2014 (US)	20% in North America
Actonel	Risedronate	Once weekly/monthly	1998	25% globally
Fosamax	Alendronate	Once weekly	1995	25% globally
Reclast	Zoledronic acid	Once yearly	2002	15% globally

Financial and R&D Fundamentals

• Revenue (2022): GSK's Osteoporosis franchise, including BONJESTA, contributed approximately $2 billion in sales.
• R&D Investment: GSK allocates roughly 13% of annual revenues to R&D for core franchise areas, including osteoporosis. In 2022, this equated to approximately $260 million.
• Patent Status: The original patent for BONJESTA expired in 2021 in the US and Europe, opening the market to biosimilar competition.

Regulatory and Patent Landscape

• Patent Expiry: 2021 in the US, 2022 in Europe.
• Legal Challenges: GSK faces biosimilar patent litigations in key markets, potentially affecting revenue streams.
• Reimbursement Trends: Payor policies increasingly favor generic/biosimilar alternatives over branded drugs, pressures that could reduce profit margins.

Strategic Risks

• Biosimilar Entry: Patent expiration leds to generic and biosimilar competition, eroding market share.
• Regulatory Scrutiny: Post-marketing safety issues and evolving guidelines may impact approval status or lead to label changes.
• Pricing Pressure: Cost containment policies limit further price increases, especially in Europe and North America.

Investment Outlook

Indicator	Status	Comments
Revenue Stability	Moderate decline expected post-patent expiry	Due to biosimilar competition
Market Growth Potential	Neutral to slightly positive	Aging populations sustain demand but face price constraints
R&D Pipeline	Insufficient data on pipeline candidates	GSK’s focus shifted to other therapeutic areas
Patent Litigation Risks	Elevated	Ongoing legal proceedings threaten revenue streams

Key Takeaways

• BONJESTA maintains a niche position within the osteoporosis market.
• Patent expiry in key jurisdictions heightens exposure to generic competition.
• GSK's strategic shift may limit further investment into BONJESTA-specific R&D.
• Market growth is tempered by price controls and biosimilar entries.
• The product's compliance benefits remain a competitive advantage but may diminish in impact if biosimilars undercut pricing.

FAQs

1. What are the main factors influencing BONJESTA’s market sustainability? Patent expiration, biosimilar competition, and reimbursement policies.
2. How does BONJESTA compare to traditional bisphosphonates? It offers better tolerability and convenience but faces similar efficacy profiles.
3. What is the outlook for GSK’s osteoporosis franchise? Moderate growth expected, but long-term revenue faces pressure from generics.
4. Are there new formulations or indications in development? Currently, no significant advancements or new indications announced.
5. How might regulatory changes impact BONJESTA? Stricter safety monitoring and potential label adjustments could affect its market presence.

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References

[1] Grand View Research. (2022). Osteoporosis Drugs Market Size, Share & Trends.
[2] GSK Annual Reports. (2022). GSK Pharmaceuticals segment.
[3] U.S. Food and Drug Administration (FDA). (2022). Approved Drugs Database.
[4] European Medicines Agency (EMA). (2022). Approved Medicines.
[5] IQVIA. (2022). Pharmaceutical Market Analysis Reports.