Suppliers and packagers for xifaxan

xifaxan

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	A-S Medication Solutions	50090-2445-0	9 TABLET in 1 BOTTLE (50090-2445-0)	2004-07-25
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	Cardinal Health 107, LLC	55154-6777-8	360 TABLET in 1 BOTTLE, PLASTIC (55154-6777-8)	2010-05-01
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	Salix Pharmaceuticals, Inc.	65649-301-03	30 TABLET in 1 BOTTLE (65649-301-03)	2004-07-25
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	Salix Pharmaceuticals, Inc.	65649-303-01	3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK	2010-05-01
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	Salix Pharmaceuticals, Inc.	65649-303-02	60 TABLET in 1 BOTTLE (65649-303-02)	2010-05-01
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	Salix Pharmaceuticals, Inc.	65649-303-03	6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK	2010-05-01

Suppliers and Market Dynamics of Xifaxan (Rifaximin): A Comprehensive Analysis

Xifaxan (rifaximin), a broad-spectrum antibacterial drug, has established itself as a critical therapeutic agent for conditions such as traveler’s diarrhea, hepatic encephalopathy (HE), and irritable bowel syndrome with diarrhea (IBS-D). Since its FDA approval in 2004, the drug’s supply chain has evolved to include a complex network of manufacturers, suppliers, and distributors across global markets. This report examines the key players in Xifaxan’s production and distribution, the regulatory and patent landscape shaping its availability, and the economic factors influencing patient access. With Salix Pharmaceuticals (a subsidiary of Bausch Health) overseeing the branded version and generic manufacturers like Sun Pharma poised for future market entry, the Rifaximin supply ecosystem reflects both competitive pressures and legal complexities[2][4][5].

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The Original Manufacturer: Salix Pharmaceuticals and Bausch Health

Salix Pharmaceuticals, founded in 1989, developed Xifaxan as part of its specialization in gastrointestinal therapeutics[2]. As a subsidiary of Bausch Health, Salix has maintained exclusive rights to the branded formulation in the U.S., leveraging patents to delay generic competition. The company’s manufacturing process involves sourcing rifaximin active pharmaceutical ingredient (API) from facilities in Canada, with final production and packaging completed domestically[4]. Salix’s strategic focus on gastrointestinal disorders has positioned Xifaxan as a cornerstone of its portfolio, contributing significantly to Bausch Health’s $8.4 billion revenue in 2021[5].

Regulatory adherence remains a priority for Salix, with compliance to Good Manufacturing Practices (GMP) ensuring consistent quality across production batches[1][6]. The company’s reliance on international API suppliers highlights the globalization of pharmaceutical supply chains, even for branded products. However, Salix’s dominance faces challenges from generic manufacturers seeking to capitalize on patent expirations, particularly after 2028[5][12].

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Regulatory Approvals and Patent Landscape

Xifaxan’s regulatory journey began with its initial FDA approval in 2004 for traveler’s diarrhea, followed by expanded indications for hepatic encephalopathy in 2010 and IBS-D in 2015[8]. These approvals solidified its market position but also triggered protracted legal battles over patent validity. Key patents protecting Xifaxan’s composition and use in IBS-D were invalidated in 2022, while those covering HE indications remain enforceable until 2029[5][13]. This bifurcation has allowed generic manufacturers like Norwich Pharmaceuticals to pursue “skinny labeling” for IBS-D, though FDA approvals remain blocked pending litigation outcomes[12][13].

The U.S. Court of Appeals for the Federal Circuit recently upheld injunctions against Norwich’s generic, ensuring no market entry until October 2029[13]. Similar settlements with Teva, Sandoz, and Sun Pharma have delayed their U.S. generics until 2028, preserving Salix’s monopoly in the near term[5][14]. Internationally, however, generic rifaximin is already available in markets like India, where Sun Pharma produces versions under brands such as Targaxan[4][9].

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Key Manufacturers and Suppliers of Rifaximin

Branded Xifaxan Suppliers

Salix Pharmaceuticals exclusively manufactures branded Xifaxan in the U.S., partnering with API suppliers like EUROAPI and LGM Pharma for raw materials[1][6]. The drug’s finished dosage form is produced under strict GMP guidelines, with distribution managed through wholesalers such as Cardinal Health and A-S Medication Solutions[11]. Despite its high cost—$3,625 for a 60-tablet supply—Xifaxan maintains a loyal patient base due to limited therapeutic alternatives[7].

Generic Rifaximin Suppliers

Outside the U.S., generic rifaximin suppliers dominate markets in Asia and Europe. Sun Pharmaceutical Industries, India’s largest pharmaceutical company, leads production with facilities approved by regulatory agencies in over 150 countries[4][9]. Other notable manufacturers include:

• Teva Pharmaceuticals: Preparing for U.S. market entry post-2028 under a settlement agreement[5].
• Sandoz (Novartis): Developing a generic version pending patent resolutions[5].
• Lupin and Aurobindo Pharma: Indian suppliers exporting to non-U.S. markets[6][9].

These manufacturers operate under certifications such as USDMF (U.S. Drug Master File) and CEP (Certificate of Suitability to the European Pharmacopoeia), ensuring compliance with international quality standards[1][3].

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Geographical Distribution of Manufacturing and Supply

Xifaxan’s supply chain spans multiple continents:

• North America: Salix’s Canadian API facilities supply U.S. production lines, while Canadian pharmacies like My Drug Center offer discounted branded Xifaxan to U.S. patients[4][10].
• Asia: India and China host major generic manufacturers, including Sun Pharma, Shandong Octagon Chemicals, and SETV Global, which export rifaximin to Africa, the Middle East, and Europe[9].
• Europe: Cambrex (Italy) and TIEFENBACHER API + Ingredients (Germany) supply APIs to regional formulators[9].

This distribution underscores the reliance on emerging markets for cost-effective generics, contrasted with the high-priced branded product in the U.S.[4][7].

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Impact of Patent Litigations on Supplier Availability

Bausch Health’s aggressive patent defense strategy has reshaped the supplier landscape. By invalidating key patents for IBS-D, the 2022 Delaware court ruling opened avenues for generics targeting that indication[5]. However, the Federal Circuit’s 2024 reaffirmation of HE-related patents ensures that no generic can include HE indications until 2029, complicating FDA approval pathways for “skinny label” generics[13].

Norwich Pharmaceuticals’ attempt to bypass HE patents by removing related data from its abbreviated new drug application (ANDA) was rejected by the FDA and courts, illustrating the regulatory hurdles facing generic suppliers[12][13]. These legal dynamics force manufacturers to delay investments in production infrastructure, limiting short-term supplier diversity.

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Pricing Strategies and Cost-Saving Options for Patients

Branded Xifaxan’s exorbitant U.S. pricing—$12.03 per 200mg tablet—drives demand for affordable alternatives[7]. Patients increasingly turn to international suppliers, with Canadian pharmacies offering savings of up to 80% through partnerships with licensed distributors[10]. Indian generics, priced at $36–$40 per kilogram of API, further reduce costs for global buyers[9]. However, U.S. importation remains illegal, compelling patients to seek alternative channels for access[4].

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Quality Assurance and Certifications in Rifaximin Supply

Quality control is paramount in rifaximin production. Suppliers must adhere to:

• GMP Compliance: Mandatory for U.S. and EU markets, ensuring batch consistency and contamination prevention[1][6].
• USDMF/CEPs: Certifications validating API quality for regulatory submissions[3][9].
• ISO 9001: General quality management standards for non-U.S. suppliers[9].

PharmaCompass and similar platforms enable buyers to filter suppliers by certification, streamlining procurement for pharmacies and healthcare providers[1][3].

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Recent Legal and Market Developments

Recent milestones include:

• Bausch vs. Amneal (2024): A new lawsuit alleging patent infringement, extending litigation to additional generic manufacturers[14].
• Sun Pharma’s 2028 Market Entry: Settlement permitting U.S. generic sales post-2028, pending final approvals[4][5].
• FDA Tentative Approvals: Norwich’s ANDA remains in limbo despite meeting efficacy standards, highlighting regulatory caution[12][13].

These developments suggest a gradual shift toward generic competition, albeit delayed by legal and procedural barriers.

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Future Outlook for Rifaximin Suppliers and Generic Entry

The post-2028 period is poised to transform the rifaximin market, with Teva, Sandoz, and Sun Pharma expected to launch U.S.-approved generics. Price reductions of 30–50% are likely, mirroring trends in other antibiotic markets[4][5]. Meanwhile, Indian and Chinese manufacturers will expand their global footprint, leveraging cost advantages to supply emerging economies. For Salix, diversification into next-generation gastrointestinal therapies may offset revenue declines as generics erode Xifaxan’s market share.

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Conclusion

The Rifaximin supply chain is a microcosm of broader pharmaceutical industry trends: globalization, patent-driven monopolies, and regulatory complexity. While Salix Pharmaceuticals currently dominates the branded market, the impending entry of generics promises enhanced affordability and access. Stakeholders must navigate evolving legal landscapes and quality standards to ensure sustainable supply, balancing innovation with patient needs. As litigation resolves and patents expire, the supplier ecosystem will likely fragment, offering new opportunities for manufacturers and cost savings for patients worldwide.

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/xifaxan-rifacol-fatroximin-rifaximin
2. https://www.mydrugcenter.com/blog/xifaxan/xifaxan-history
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/xifaxan-rifacol-fatroximin-rifaximin
4. https://www.pharmacychecker.com/askpc/save-money-xifaxan-rifaximin-generic/
5. https://www.fiercepharma.com/pharma/bausch-takes-hit-xifaxan-patent-feud-potentially-paving-way-norwichs-ibs-generic
6. https://www.pharmacompass.com/ndc-api/xifaxan
7. https://www.drugs.com/price-guide/xifaxan
8. https://www.drugs.com/history/xifaxan.html
9. https://pharmaoffer.com/api-excipient-supplier/antibacterials/rifaximin
10. https://www.mydrugcenter.com/blog/xifaxan/savings-guide-xifaxan
11. https://www.findacode.com/ndc/drugs/XIFAXAN
12. https://www.fiercepharma.com/pharma/alvogens-bid-force-fda-approve-generic-bausch-healths-ibd-d-med-xifaxan-shot-down-dc-court
13. https://drugstorenews.com/bausch-wins-us-appeal-block-norwichs-generic-xifaxan
14. https://drugstorenews.com/bausch-health-files-patent-lawsuit-against-amneal-over-generic-xifaxan