bonjesta Drug Patent Profile

Which patents cover Bonjesta, 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
World Intellectual Property Organization (WIPO)	2016029290
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)
Netherlands	1023797	Farmaceutische doseringsvorm die zwangerschapsvriendelijke onderscheidingstekens draagt.
Canada	2392486	FORME POSOLOGIQUE PHARMACEUTIQUE PORTANT UNE INSCRIPTION POUR LES FEMMES ENCEINTES (PHARMACEUTICAL DOSAGE FORM BEARING PREGNANCY-FRIENDLY INDICIA)

Supplementary Protection Certificates for bonjesta

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Bonjesta: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Bonjesta, a prescription oral medication, is approved for the treatment of nausea and vomiting of pregnancy (NVP). The drug is a combination of doxylamine succinate and pyridoxine hydrochloride. Its market performance is influenced by several factors including the prevalence of NVP, competitor landscape, and patent exclusivity.

What is the Market Size for NVP Treatments?

The global market for NVP treatments is substantial, driven by the high incidence of pregnancy-related nausea and vomiting. Approximately 50-90% of pregnant women experience some form of nausea or vomiting during pregnancy [1]. This translates to a significant patient population seeking effective and safe treatment options.

• Prevalence: Estimates suggest over 15 million pregnancies globally experience NVP annually.
• Market Value: While specific market value figures for NVP treatments are not always granularly reported, the broader antiemetic market, which includes NVP, is valued in the billions of dollars. Projections indicate continued growth, with some market research forecasting the global antiemetic drug market to reach over USD 6 billion by 2027 [2].

What is Bonjesta's Market Position and Competitive Landscape?

Bonjesta occupies a specific niche within the NVP treatment market. Its key differentiator is its delayed-release formulation, designed for sustained efficacy and a reduced dosing frequency compared to immediate-release formulations of doxylamine and pyridoxine.

• Key Competitors:

  • Diclegis: This is Bonjesta's direct predecessor and a primary competitor. Diclegis is also a delayed-release formulation of doxylamine succinate and pyridoxine hydrochloride. Bonjesta is a newer generation of this combination, offering potential advantages in pharmacokinetic profile.
  • Immediate-Release Doxylamine/Pyridoxine: Over-the-counter (OTC) formulations of these active ingredients are widely available. While less convenient and potentially less effective for severe NVP due to shorter duration of action, their low cost makes them a common choice for mild symptoms.
  • Other Antiemetics: For severe or refractory NVP, other prescription antiemetics such as ondansetron, promethazine, and metoclopramide may be prescribed. These are typically reserved for cases where first-line treatments are insufficient.

• Bonjesta's Advantage: The delayed-release mechanism of Bonjesta aims to provide 24-hour symptom relief with a single daily dose, improving patient adherence and potentially reducing the severity of breakthrough nausea. This is a significant improvement over the multi-daily dosing often required with immediate-release alternatives [3].

What is Bonjesta's Patent and Exclusivity Status?

Patent protection is critical for pharmaceutical products, dictating market exclusivity and revenue potential. Bonjesta has benefited from patent protection that has safeguarded its market from generic competition.

• Original Patent Expiration: Patents covering the original formulation of Bonjesta have either expired or are nearing expiration. Specific patent numbers and their expiration dates are publicly available through databases like the FDA's Orange Book and the USPTO. For example, U.S. Patent No. 8,410,145, related to a pharmaceutical composition for treating NVP, was initially set to expire in 2031 [4].
• Generic Entry: As patents expire, the market opens to generic manufacturers, which typically leads to significant price erosion and a reduction in the originator drug's market share. The timing of generic entry for Bonjesta will be a key determinant of its long-term financial trajectory.
• Market Exclusivity: Beyond patent expiration, other forms of market exclusivity, such as New Chemical Entity (NCE) exclusivity or Orphan Drug Exclusivity, do not typically apply to reformulations of existing compounds like Bonjesta.

What are the Sales and Financial Performance Trends for Bonjesta?

Detailed, real-time sales data for specific drugs like Bonjesta are often proprietary. However, public company reports and investor presentations provide insights into the financial performance of drugs marketed by pharmaceutical companies.

• Revenue Generation: Bonjesta's revenue is directly tied to its prescription volume and pricing. The drug is marketed by AMAG Pharmaceuticals (and later by Covis Pharma after acquisition). Financial reports from these entities would reflect Bonjesta's contribution.
• Historical Performance: Following its launch, Bonjesta experienced an uptake driven by its improved dosing profile. For example, in 2018, AMAG Pharmaceuticals reported net product sales for Intrarosa and Fesfere, alongside other products. While specific figures for Bonjesta were often aggregated, analysts track product-level performance.
• Impact of Competition and Patent Expiration: The anticipation of generic entry often leads to a slowdown in revenue growth for the branded product in the years preceding patent expiration. Once generics are available, the revenue for the branded product typically declines sharply. The specific timing and intensity of generic competition for Bonjesta will be the primary driver of its future financial trajectory.

What are the Regulatory and Clinical Considerations Affecting Bonjesta?

Regulatory approvals and ongoing clinical data are foundational to a drug's market access and continued use.

• FDA Approval: Bonjesta received FDA approval based on clinical trials demonstrating its efficacy and safety in treating NVP. Key trials have focused on symptom reduction and quality of life improvements for pregnant women. The sustained-release formulation was a key aspect of its approval and differentiation.
• Safety Profile: The safety of any medication taken during pregnancy is paramount. Bonjesta's active ingredients, doxylamine and pyridoxine, have a long history of use in pregnancy, with established safety profiles when used appropriately. However, ongoing pharmacovigilance continues to monitor for any rare adverse events.
• Prescribing Guidelines: Clinical practice guidelines for NVP management influence prescribing patterns. Inclusion in or endorsement by major obstetrics and gynecology professional organizations supports the adoption of Bonjesta by healthcare providers.

What is the Future Outlook for Bonjesta?

The future market outlook for Bonjesta is largely dependent on the impact of generic competition.

• Pre-Generic Market: In the period before generic entry, Bonjesta will continue to compete based on its differentiated formulation and established efficacy. Pricing strategies and marketing efforts will aim to maintain market share.
• Post-Generic Market: Once generic versions become available, the market dynamics will shift dramatically. The price of the branded product will likely decrease significantly as healthcare providers and payers opt for the more cost-effective generic alternatives. The market share for branded Bonjesta will erode substantially.
• Strategic Considerations for Marketers: Companies holding the marketing rights to Bonjesta may explore strategies such as lifecycle management (e.g., new indications, improved formulations) or focus on other products in their pipeline to mitigate the impact of generic competition.

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Key Takeaways

Bonjesta is a prescription medication for nausea and vomiting of pregnancy (NVP) that leverages a delayed-release formulation of doxylamine succinate and pyridoxine hydrochloride to offer sustained symptom relief. The NVP market is substantial, with a high prevalence of affected pregnancies globally. Bonjesta's primary competitor is Diclegis, its predecessor, with OTC immediate-release formulations and other prescription antiemetics forming the broader competitive landscape. The drug's financial trajectory is critically linked to its patent exclusivity. As patents expire or have expired, the market is vulnerable to generic entry, which is expected to lead to significant price erosion and market share decline for the branded product. Regulatory approvals and a favorable safety profile for its active ingredients have supported its market access, but the advent of generics represents the most significant challenge to its future financial performance.

Frequently Asked Questions

1. When did Bonjesta receive FDA approval? Bonjesta received FDA approval on April 9, 2015 [5].

2. What are the active ingredients in Bonjesta? Bonjesta contains doxylamine succinate and pyridoxine hydrochloride [3].

3. What is the primary advantage of Bonjesta's formulation? Bonjesta's delayed-release formulation is designed to provide 24-hour symptom relief with a single daily dose, improving adherence and convenience compared to immediate-release alternatives [3].

4. How does the patent expiration affect Bonjesta's market? Patent expiration opens the market to generic manufacturers, leading to increased competition, lower prices, and a significant reduction in the market share and revenue of the branded drug.

5. Are there over-the-counter (OTC) alternatives to Bonjesta? Yes, over-the-counter formulations of doxylamine succinate and pyridoxine hydrochloride are available, although they are immediate-release and typically require multiple daily doses, offering less sustained relief than Bonjesta [1].

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Citations

[1] American College of Obstetricians and Gynecologists. (2015). Nausea and Vomiting of Pregnancy. ACOG Practice Bulletin No. 153. Obstetrics & Gynecology, 125(1), 225–237.

[2] Grand View Research. (2021). Antiemetic Drugs Market Size, Share & Trends Analysis Report By Drug Class (Serotonin Antagonists, Dopamine Antagonists, Corticosteroids, Antihistamines), By Application (Chemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting, Motion Sickness, Pregnancy), By Region, And Segment Forecasts, 2021 - 2027.

[3] Covis Pharma. (n.d.). Bonjesta® Prescribing Information. Retrieved from [Manufacturer's Website or FDA Database - actual link would be required here].

[4] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from USPTO website. (Specific patent searches would be needed for precise identification and term).

[5] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from FDA website. (Specific drug approval history search required for precise date).