~ Buy the BONJESTA (doxylamine succinate; pyridoxine hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

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-four patent family members in thirty-one 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:	64
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
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

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
Ukraine	118711	ПРЕПАРАТ З БАГАТОРЕЖИМНИМ ВИВІЛЬНЕННЯМ, ЯКИЙ МІСТИТЬ ДОКСИЛАМІН І ПІРИДОКСИН І/АБО ЇХ МЕТАБОЛІТИ АБО СОЛІ (PLURIMODAL RELEASE FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Argentina	122580	FORMA DE DOSIFICACIÓN DE DOXILAMINA Y PIRIDOXINA Y/O SUS METABOLITOS O SALES
European Patent Office	3185856	FORMULATION À LIBÉRATION PLURIMODALE À BASE DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE MÉTABOLITES OU DE SELS ASSOCIÉS (PLURIMODAL RELEASE FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)

BONJESTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BONJESTA

Introduction

BONJESTA, a fixed-dose combination of doxylamine succinate and pyridoxine hydrochloride, is a significant player in the market for treating nausea and vomiting of pregnancy (NVP). Here, we delve into the market dynamics and financial trajectory of BONJESTA, exploring its launch, regulatory approvals, market positioning, and financial implications.

Regulatory Approval and Launch

BONJESTA received FDA approval in 2016, building on the safety and efficacy data from its predecessor, Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets. The drug was launched by Duchesnay USA in April 2018, marking a significant milestone in the treatment of NVP, a condition affecting up to 85% of pregnant women[1][4].

Market Positioning

BONJESTA is positioned as a first-line pharmacotherapy for NVP after conservative management has failed, as recommended by the American College of Obstetrics and Gynecology (ACOG)[1]. This recommendation underscores its importance in the therapeutic landscape for pregnant women.

Competitive Landscape

The market for NVP treatments includes other formulations like Diclegis, also from Duchesnay USA. While Diclegis requires a higher pill burden (up to four tablets per day), BONJESTA offers a reduced pill burden with a maximum daily dose of two tablets, potentially improving patient adherence[1][5].

Patient Affordability Programs

To enhance accessibility, Duchesnay USA has implemented dedicated affordability programs for BONJESTA, including copay assistance and a patient assistance program for those in need. These initiatives help mitigate the financial burden on patients and can positively impact the drug's market traction[1].

Pharmacokinetics and Efficacy

BONJESTA's multilayer, extended-release formulation provides both fast-acting and long-lasting symptom relief. Clinical trials have demonstrated its bioequivalence to Diclegis, ensuring similar efficacy with a more convenient dosing regimen[2][4].

Safety and Warnings

While BONJESTA is generally well-tolerated, it carries warnings for somnolence and severe drowsiness due to the anticholinergic properties of doxylamine succinate. Patients are advised to avoid activities requiring complete mental alertness and to avoid concurrent use with CNS depressants, including alcohol[2][4].

Financial Trajectory

Revenue Potential

Given its FDA approval and ACOG recommendation, BONJESTA has significant revenue potential. The drug addresses a common and debilitating condition in a large patient population, which can drive demand and sales.

Cost and Pricing

The cost of BONJESTA is a critical factor in its financial trajectory. While specific pricing details are not publicly disclosed, the availability of patient assistance programs suggests an effort to balance revenue goals with patient affordability[1].

Market Competition

The presence of Diclegis and other NVP treatments in the market means BONJESTA must compete for market share. However, its reduced pill burden and extended-release formulation can be differentiators that attract patients and healthcare providers[1][5].

Economic Impact on the Pharmaceutical Industry

Follow-On Drugs

BONJESTA exemplifies the concept of "follow-on" drugs, which are often criticized for being duplicative but can provide needed therapeutic options and inject price competition into the market. Studies suggest that such drugs can reduce entry barriers and increase competitiveness in the pharmaceutical industry[3].

Development and Approval Process

The development and approval process for BONJESTA highlights the evolving landscape of drug development. With a shorter period of marketing exclusivity compared to earlier decades, the pharmaceutical industry is becoming more competitive, driving innovation and potentially reducing costs[3].

Patient and Healthcare Provider Perspectives

Patient Adherence

The reduced pill burden of BONJESTA can significantly improve patient adherence, which is crucial for the effective management of NVP. Improved adherence can lead to better health outcomes and reduced healthcare costs in the long term[1].

Healthcare Provider Recommendations

Healthcare providers play a vital role in recommending BONJESTA. The ACOG recommendation and the drug's efficacy profile make it a preferred option for many providers, influencing its market dynamics and financial performance[1].

Key Takeaways

• Regulatory Approval: BONJESTA received FDA approval in 2016 and was launched in 2018.
• Market Positioning: It is recommended as a first-line pharmacotherapy for NVP after conservative management fails.
• Competitive Landscape: BONJESTA competes with Diclegis but offers a reduced pill burden.
• Patient Affordability: Dedicated affordability programs are available to enhance accessibility.
• Financial Trajectory: Significant revenue potential driven by demand and competitive advantages.
• Economic Impact: Contributes to increased competitiveness and innovation in the pharmaceutical industry.

FAQs

Q: What is BONJESTA used for?

BONJESTA is used for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.

Q: How is BONJESTA different from Diclegis?

BONJESTA has a reduced pill burden (maximum of two tablets daily) compared to Diclegis (up to four tablets daily) and is formulated as an extended-release tablet.

Q: What are the potential side effects of BONJESTA?

BONJESTA may cause somnolence and severe drowsiness due to its anticholinergic properties. It should be used with caution in women with certain medical conditions.

Q: Is BONJESTA covered by patient assistance programs?

Yes, Duchesnay USA offers dedicated affordability programs, including copay assistance and a patient assistance program, to make BONJESTA more accessible.

Q: How does BONJESTA impact the pharmaceutical industry?

BONJESTA contributes to increased competitiveness and innovation in the pharmaceutical industry by providing a needed therapeutic option and injecting price competition into the market.

Sources

1. Duchesnay USA Announces Launch of Bonjesta® (doxylamine succinate and pyridoxine hydrochloride) in the United States. PR Newswire.
2. BONJESTA (doxylamine succinate and pyridoxine hydrochloride) Extended-Release Tablets. FDA.
3. The economics of follow-on drug research and development. PubMed.
4. Bonjesta: Package Insert / Prescribing Information. Drugs.com.
5. Doxylamine-Pyridoxine Fixed Dose Combinations. Minnesota.gov.