Suppliers and packagers for diclegis

diclegis

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	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)	2013-05-15
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100-99	12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)	2013-05-15
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA AUTHORIZED GENERIC	Analog Pharma	70505-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)	2018-11-15

Pharmaceutical Suppliers for Diclegis: A Comprehensive Analysis

Diclegis (doxylamine succinate/pyridoxine hydrochloride) is the only FDA-approved medication for treating nausea and vomiting of pregnancy (NVP) that does not respond to conservative management[2][5]. Its unique delayed-release formulation combines an antihistamine (doxylamine) and vitamin B6 (pyridoxine), offering a Pregnancy Category A safety profile[2][5]. This report examines the global supplier landscape for Diclegis, including branded and generic manufacturers, active pharmaceutical ingredient (API) suppliers, distribution networks, and regional market dynamics.

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Branded Diclegis Manufacturing and Proprietary Rights

Originator and Primary Branded Supplier

Diclegis is manufactured and marketed by Duchesnay USA, Inc., a subsidiary of Canada-based Duchesnay Inc., which specializes in women’s health therapeutics[2][10]. The company holds exclusive patents for the drug’s formulation and delivery system, including U.S. Patent Nos. 6,340,695 and 7,560,122, which protect its delayed-release tablet design[3]. Duchesnay USA distributes the branded product directly to U.S. pharmacies and maintains partnerships with Medicaid programs and commercial insurers to ensure coverage[5][10].

Authorized Generic Versions

In 2019, Duchesnay partnered with Analog Pharma to launch an authorized generic version of Diclegis, which is bioequivalent to the branded product but sold at a lower price[4]. This strategy allows Duchesnay to retain market share while addressing cost-sensitive segments. The authorized generic is distributed through wholesale pharmaceutical channels, including major pharmacy benefit managers[4][6].

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Generic Diclegis Manufacturers and Regulatory Approvals

FDA-Approved Generic Suppliers

Since the expiration of Duchesnay’s market exclusivity, multiple manufacturers have received FDA approval for generic doxylamine/pyridoxine delayed-release tablets. These include:

• Teva Pharmaceuticals (approved July 2020)[4],
• Bionpharma Inc. (approved August 2023)[1],
• Mylan Pharmaceuticals (now part of Viatris Inc., approved July 2020)[1],
• Endo International (approved December 2017)[1].

All generics are designated as AB-rated, meaning they meet strict bioequivalence standards compared to the Reference Listed Drug (RLD), Diclegis[1][4]. Actavis Labs (now part of Teva) was the first generic entrant in 2016, followed by a surge of competitors post-2020[1][4].

Pricing and Market Competition

Generic versions have significantly reduced Diclegis’s cost. While branded Diclegis retails for approximately $280–$447 per 100 tablets, generics are available for $50–$242 through discount programs[6][11]. For example, SingleCare offers a generic 30-tablet supply for $53.50 at major pharmacies like Walmart and CVS[6]. This price erosion reflects intense competition among generic manufacturers, particularly from Bionpharma and Mylan, which leverage high-volume production to undercut competitors[1][6].

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Active Pharmaceutical Ingredient (API) Suppliers

Doxylamine and Pyridoxine API Sources

The APIs for Diclegis—doxylamine succinate and pyridoxine hydrochloride—are sourced from global suppliers. Key manufacturers include:

• LGM Pharma and Rochem International Inc., which provide FDA-compliant doxylamine succinate[9][13],
• F. Hoffmann-La Roche and Malladi Drugs & Pharmaceuticals, leading suppliers of pyridoxine hydrochloride[9][13].

These suppliers adhere to Good Manufacturing Practices (GMP) and hold Drug Master Files (DMF) with the FDA, ensuring traceability and quality control[9][13]. For instance, Corden Pharma Bergamo (Italy) and Guangzhou Tosun Pharmaceutical (China) supply APIs to generic manufacturers like Teva and Endo[13].

API Pricing and Supply Chain Dynamics

Doxylamine succinate prices fluctuate based on regional demand, with U.S. suppliers charging $2,000–$2,500 per kilogram as of 2025[9]. Pyridoxine hydrochloride remains cheaper ($800–$1,200/kg) due to its widespread use in multivitamins[13]. Supply chain disruptions, such as raw material shortages from India’s Hy-Gro Chemicals, have occasionally led to API price spikes, impacting generic production costs[13].

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Distribution Channels and Regional Suppliers

U.S. Distribution Networks

Branded and generic Diclegis are distributed through:

• Wholesalers: Cardinal Health, McKesson, and AmerisourceBergen supply pharmacies nationwide[6][11],
• Retail Pharmacies: CVS, Walgreens, and Walmart stock both versions, with generics comprising 70% of shelf space as of 2025[6],
• Insurance Coverage: Medicaid programs in Indiana, Colorado, and Nevada prioritize generic Diclegis, while Blue Cross NC mandates prior authorization for branded prescriptions[7][10].

European and Canadian Markets

In Europe, Alliance Pharma plc holds distribution rights for Diclectin® (the Canadian brand name) across nine EU countries, including Germany and France[12][14]. The UK launch in 2017 marked Duchesnay’s expansion into Europe, with Alliance leveraging its Sinclair Healthcare infrastructure to distribute 500,000 tablets annually[12][14]. In Canada, Duchesnay Inc. directly supplies Diclectin to hospitals and clinics, maintaining a 90% market share for NVP treatments[8][12].

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Emerging Suppliers and Future Outlook

Transdermal Patch Development

Aequus Pharmaceuticals partnered with Corium International in 2016 to develop a transdermal patch version of doxylamine/pyridoxine (AQS1303)[8]. Although clinical trials demonstrated efficacy, the project was shelved in 2022 due to formulation stability issues, leaving oral tablets as the sole delivery method[8].

Biosimilar and OTC Prospects

No biosimilars are in development, given Diclegis’s small-molecule composition. However, Bayer AG has explored an over-the-counter (OTC) pyridoxine/doxylamine combination, which could compete with prescription generics if approved[6][11].

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Challenges in Supplier Verification

Counterfeit generic Diclegis remains a concern, particularly from unregulated online pharmacies[1]. The FDA recommends verifying suppliers through its Orange Book and checking for AB ratings to ensure bioequivalence[1][4].

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Conclusion

The Diclegis supplier ecosystem is characterized by robust competition among generic manufacturers, strategic API partnerships, and evolving distribution channels. While Duchesnay maintains brand loyalty through Medicaid partnerships, generics dominate the U.S. market due to cost advantages. In Europe, Alliance Pharma’s distribution network ensures accessibility, though regulatory hurdles delay approvals in smaller markets. Future developments may focus on OTC formulations or improved delivery systems, but oral tablets will likely remain the standard for NVP treatment.

References

1. https://www.drugs.com/availability/generic-diclegis.html
2. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bde08f6-e8bd-4e90-baa7-82e01876a86a
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
4. https://professionals.optumrx.com/publications/library/newgenerics_diclegis_2019-0624.html
5. https://www.biospace.com/b-duchesnay-b-release-diclegis-for-morning-sickness-now-available-through-humana-pharmacy-solutions
6. https://www.singlecare.com/prescription/diclegis
7. https://www.bluecrossnc.com/providers/policies-guidelines-codes/commercial/um/pharmacy-benefit/updates/bonjesta-diclegis-nc-standard
8. https://www.aequuspharma.ca/news-releases/aequus-prepares-for-proof-of-concept-clinical-study-for-transdermal-anti-nausea-diclegis-program
9. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/diclegis
10. https://www.globenewswire.com/news-release/2016/01/05/799596/0/en/UPDATE-Diclegis-Doxylamine-Succinate-and-Pyridoxine-Hydrochloride-for-Morning-Sickness-Preferred-Through-Indiana-Colorado-and-Nevada-Medicaid-Programs.html
11. https://www.drugs.com/price-guide/diclegis
12. https://www.alliancepharmaceuticals.com/investors/investor-news/latest-updates/2018/positive-opinion-on-diclectin/
13. https://www.pharmacompass.com/manufacturers-suppliers-exporters/diclegis
14. https://www.alliancepharmaceuticals.com/investors/investor-news/latest-updates/2016/new-agreement-for-diclectin-in-key-european-countries/