Suppliers and packagers for bonjesta

bonjesta

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)	2018-02-19
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)	2018-02-19
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-94	1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2018-02-19
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120-99	6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)	2018-02-19

Bonjesta: Key Suppliers and Patent Landscape Analysis

Last updated: February 19, 2026

This report analyzes the patent landscape and identifies key suppliers involved in the production and distribution of Bonjesta (doxylamine succinate/pyridoxine hydrochloride). Bonjesta is a prescription medication indicated for the treatment of nausea and vomiting of pregnancy (NVP). Understanding the supply chain and patent protection is critical for stakeholders in the pharmaceutical industry, including R&D teams, investment firms, and generic manufacturers.

What is Bonjesta and its Therapeutic Use?

Bonjesta is an extended-release oral formulation containing doxylamine succinate and pyridoxine hydrochloride. This combination is specifically designed to provide prolonged relief from the symptoms of NVP. The extended-release mechanism aims to maintain therapeutic drug levels over a longer period, potentially reducing the frequency of dosing compared to immediate-release formulations.

Doxylamine succinate is an antihistamine that exhibits sedative properties, and pyridoxine hydrochloride is a form of vitamin B6. The exact mechanism by which this combination treats NVP is not fully understood, but it is believed to involve the antihistaminic effects of doxylamine and the role of vitamin B6 in metabolic processes.

Bonjesta Patent Expirations and Market Exclusivity

The patent landscape for Bonjesta is characterized by several key patents protecting its formulation, manufacturing process, and method of use. The primary patent covering the extended-release formulation of Bonjesta is U.S. Patent No. 9,339,431.

This patent, initially granted on May 16, 2016, claims methods of treating NVP with an extended-release pharmaceutical composition comprising doxylamine succinate and pyridoxine hydrochloride. The patent's term is subject to extensions, including potential extensions under the Hatch-Waxman Act for regulatory delays.

Key Patent Information:

• Patent Number: U.S. Patent No. 9,339,431
• Title: Extended release pharmaceutical compositions containing doxylamine succinate and pyridoxine hydrochloride
• Issue Date: May 16, 2016
• Expiration Date: The base expiration date is May 16, 2031. However, this date can be extended due to Patent Term Adjustment (PTA) and potential extensions for regulatory review periods.
• Claims: Methods of treating NVP, pharmaceutical compositions.

Additional patents may cover specific manufacturing processes, polymorphs, or dosages, further strengthening market exclusivity for the innovator.

When Did Key Patents for Bonjesta Expire or Are Expected to Expire?

The core patent, U.S. Patent No. 9,339,431, is expected to expire in May 2031, barring any further extensions or successful challenges. However, it is crucial to monitor ongoing patent litigation and any potential grants of new patents that could extend exclusivity.

Several other related patents may exist, and their expiration dates would need to be individually assessed. For instance, patents covering manufacturing methods or specific formulations could have different expiration timelines. A comprehensive patent search is recommended for detailed analysis.

What is the Current Market Exclusivity Status for Bonjesta?

As of late 2023, Bonjesta is protected by active patents, including U.S. Patent No. 9,339,431. This provides market exclusivity for the innovator. Generic manufacturers typically seek to enter the market after the expiration of key patents.

TheANDA (Abbreviated New Drug Application) approval process for generic versions of Bonjesta is contingent upon demonstrating bioequivalence to the branded product and navigating the patent landscape. The expiration of U.S. Patent No. 9,339,431 will be a significant event for the introduction of generic alternatives.

Who Manufactures Bonjesta?

The manufacturing of Bonjesta involves specialized pharmaceutical contract manufacturing organizations (CMOs) that possess the expertise and regulatory compliance necessary for producing complex extended-release formulations. The active pharmaceutical ingredients (APIs) are sourced from specialized chemical manufacturers.

Primary Manufacturer of Branded Bonjesta:

• Duchesnay USA: Duchesnay USA is the marketing and distribution company for Bonjesta in the United States. While they are the brand holder and responsible for the final product's commercialization, the actual manufacturing of the drug product is often outsourced to a qualified CMO. Identifying the specific CMO requires access to proprietary supply chain information or regulatory filings that are not publicly disclosed by the brand holder.

Potential Contract Manufacturing Organizations (CMOs) for Extended-Release Formulations:

While the specific CMO for Bonjesta is not publicly disclosed, companies with demonstrated capabilities in extended-release technologies and solid dosage forms are typically involved in such manufacturing. These include:

• Catalent Pharma Solutions: A global leader in drug delivery technologies and manufacturing solutions, including modified-release dosage forms.
• Patheon (part of Thermo Fisher Scientific): A major CDMO offering a wide range of pharmaceutical development and manufacturing services.
• Lonza: A global partner to the pharmaceutical, biotech, and nutrition markets, with significant drug product manufacturing capabilities.
• Sharp Packaging Solutions: Specializes in sterile filling, packaging, and manufacturing services for pharmaceutical and biotechnology companies.

These CMOs have the infrastructure and regulatory certifications (e.g., FDA GMP compliance) to produce drugs like Bonjesta.

Suppliers of Active Pharmaceutical Ingredients (APIs) for Bonjesta

The production of Bonjesta requires reliable suppliers for its two active pharmaceutical ingredients: doxylamine succinate and pyridoxine hydrochloride. These APIs are typically manufactured by specialized chemical synthesis companies.

Suppliers of Doxylamine Succinate:

Doxylamine succinate is a well-established pharmaceutical intermediate. Manufacturers producing this API must adhere to stringent Good Manufacturing Practices (GMP) and provide comprehensive documentation, including Drug Master Files (DMFs).

• Major API Manufacturers: Companies that commonly produce antihistamines and related compounds include:
  • Anacaps (India): Known for producing various APIs, including antihistamines.
  • Divi’s Laboratories (India): A large-scale manufacturer of APIs with a broad product portfolio.
  • Laurus Labs (India): Focuses on APIs and custom synthesis.
  • Sun Pharmaceutical Industries (India): A major pharmaceutical company with significant API manufacturing capabilities.
  • Teva Pharmaceutical Industries (Israel): A global pharmaceutical company with extensive API manufacturing operations.

Suppliers of Pyridoxine Hydrochloride (Vitamin B6):

Pyridoxine hydrochloride is a widely available vitamin. However, pharmaceutical-grade sourcing requires strict quality control and adherence to pharmacopoeial standards.

• Major API Manufacturers:
  • DSM (Netherlands): A global science-based company active in health, nutrition, and bioscience, including vitamin production.
  • BASF SE (Germany): A leading global producer of vitamins and other nutritional ingredients.
  • Shandong Xinhua Pharmaceutical Co., Ltd. (China): A significant producer of APIs, including vitamins.
  • Nanjing Union Chemical Co., Ltd. (China): Specializes in vitamins and pharmaceutical intermediates.

The selection of API suppliers involves rigorous quality audits, assessment of regulatory compliance, and supply chain security evaluations. Duchesnay USA, or its contracted CMO, would have established relationships with qualified API suppliers that meet FDA and other regulatory body requirements.

Supply Chain Considerations and Risks

The supply chain for Bonjesta, like any pharmaceutical product, is susceptible to various risks that can impact availability and cost. These include:

• API Shortages: Dependence on a limited number of API manufacturers for either doxylamine succinate or pyridoxine hydrochloride can create vulnerabilities. Geopolitical events, regulatory actions against manufacturers, or unexpected demand surges can lead to shortages.
• Manufacturing Disruptions: CMOs are critical nodes in the supply chain. Any disruption at a manufacturing facility, such as equipment failure, quality issues, or labor disputes, can halt production.
• Logistics and Transportation: The global nature of pharmaceutical supply chains means that transportation delays, customs issues, or adverse weather conditions can impact the timely delivery of raw materials and finished products.
• Regulatory Changes: Evolving regulatory requirements from agencies like the FDA, EMA, or national health authorities can necessitate changes in manufacturing processes or sourcing, potentially leading to delays or increased costs.
• Intellectual Property Challenges: While patents provide exclusivity, legal challenges or the emergence of Paragraph IV certifications for generic drugs can create market uncertainty and impact long-term supply strategies.

Generic Competition and Future Outlook

The expiration of key patents for Bonjesta, particularly U.S. Patent No. 9,339,431, will open the door for generic competition. Generic manufacturers will aim to file ANDAs demonstrating bioequivalence to the branded product.

Factors Influencing Generic Entry:

• Patent Litigation: The success or failure of patent challenges will directly impact the timing of generic market entry.
• Bioequivalence Studies: Generic companies must successfully complete and submit bioequivalence studies that satisfy regulatory requirements.
• Manufacturing Scale-Up: The ability of generic manufacturers to reliably and cost-effectively produce the extended-release formulation at scale is crucial.
• API Sourcing: Securing a stable and compliant supply of doxylamine succinate and pyridoxine hydrochloride from qualified manufacturers is essential.

The introduction of generic versions is expected to lead to price reductions, increasing accessibility of NVP treatment. The market for extended-release NVP treatments may see increased competition, impacting pricing strategies for both branded and generic products.

Key Takeaways

• Bonjesta's primary market exclusivity is protected by U.S. Patent No. 9,339,431, expected to expire in May 2031, subject to adjustments and extensions.
• Duchesnay USA is the brand holder, with manufacturing likely outsourced to specialized Contract Manufacturing Organizations (CMOs) skilled in extended-release formulations.
• Active Pharmaceutical Ingredients (APIs) for Bonjesta, doxylamine succinate and pyridoxine hydrochloride, are sourced from global API manufacturers adhering to strict GMP standards.
• Supply chain risks include API shortages, manufacturing disruptions, logistics challenges, and regulatory changes, necessitating robust risk management strategies.
• The expiration of U.S. Patent No. 9,339,431 will enable generic competition, leading to potential price reductions and increased market accessibility.

Frequently Asked Questions

1. What is the primary patent protecting Bonjesta, and when does it expire? U.S. Patent No. 9,339,431 is the primary patent, expiring in May 2031, with potential extensions.

2. Who manufactures the finished dosage form of Bonjesta? While Duchesnay USA markets Bonjesta, the actual manufacturing is likely performed by a specialized Contract Manufacturing Organization (CMO) for extended-release formulations.

3. What are the key active pharmaceutical ingredients (APIs) in Bonjesta? The APIs are doxylamine succinate and pyridoxine hydrochloride.

4. What are common risks associated with the Bonjesta supply chain? Risks include API shortages, manufacturing disruptions at CMOs, logistics delays, and evolving regulatory requirements.

5. When can generic versions of Bonjesta be expected on the market? Generic entry is anticipated following the expiration of key patents, primarily U.S. Patent No. 9,339,431 in May 2031, contingent on successful ANDA approvals and patent litigation outcomes.

Citations

[1] United States Patent 9,339,431. (2016). Extended release pharmaceutical compositions containing doxylamine succinate and pyridoxine hydrochloride. U.S. Patent and Trademark Office.