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Suppliers and packagers for generic pharmaceutical drug: OBETICHOLIC ACID
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OBETICHOLIC ACID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999 | NDA | Intercept Pharmaceuticals Inc | 69516-005-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-005-30) | 2016-05-27 |
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999 | NDA | Intercept Pharmaceuticals Inc | 69516-010-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-010-30) | 2016-05-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Global Supplier Landscape and Market Dynamics of Obeticholic Acid
Obeticholic acid, a farnesoid X receptor agonist, has emerged as a critical therapeutic agent for chronic liver diseases such as primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH). As patent protections expire and generic competition intensifies, understanding the global supplier ecosystem for this active pharmaceutical ingredient (API) becomes paramount for stakeholders in the pharmaceutical industry. This report provides a comprehensive analysis of obeticholic acid suppliers, manufacturing hubs, regulatory frameworks, and market trends shaping availability and pricing.
Global Supplier Landscape of Obeticholic Acid
Key Manufacturing Hubs and Regional Dominance
The production of obeticholic acid is concentrated in Asia, North America, and Europe, with India and China accounting for over 70% of global API supply[1][2][6]. India’s dominance is driven by cost-efficient manufacturing capabilities and a robust generic drug industry, with companies like Biophore India Pharmaceuticals, Kimia Biosciences, and Optimus Pharma leading exports to over 44 countries[1][6][9]. China’s role is bolstered by firms such as Aurisco Pharmaceutical and BrightGene Bio-Medical Technology, which cater to domestic demand and serve markets in Europe and Southeast Asia[1][2]. In contrast, U.S.-based suppliers like LGM Pharma focus on high-margin markets, leveraging FDA-compliant facilities to supply North American and European clients[4][10].
Regulatory Certifications and Quality Standards
Compliance with Good Manufacturing Practices (GMP) and certifications such as U.S. Drug Master Files (USDMF) and European CEPs is a critical differentiator. Biophore India and Alembic Pharmaceuticals hold USDMF approvals, enabling them to supply APIs for branded and generic formulations in regulated markets[1][12]. Similarly, LGM Pharma maintains FDA-compliant facilities, ensuring adherence to stringent purity and stability requirements[4][10]. Emerging suppliers in Bangladesh and Vietnam, however, often lack these certifications, limiting their market access to non-regulated regions[6].
Leading Suppliers and Competitive Strategies
Major API Manufacturers and Their Market Positioning
Biophore India Pharmaceuticals has positioned itself as a leader in niche APIs, with obeticholic acid constituting 15% of its portfolio. The company’s vertically integrated operations—from R&D to commercial-scale production—allow it to offer competitive pricing at $8,000–$10,000 per kilogram[1][9]. Intercept Pharmaceuticals, the originator of obeticholic acid (marketed as Ocaliva®), relies on contract manufacturers in Europe and the U.S. to meet demand for its branded product while retaining control over pediatric exclusivity extensions[3][5]. Post-patent expiration, generic manufacturers like Apotex Inc. and Msn Laboratories have entered the market, offering APIs at 30–40% lower prices[13].
Strategic Alliances and Licensing Agreements
Collaborations between innovators and generic suppliers are reshaping supply chains. For instance, Intercept Pharmaceuticals licenses obeticholic acid to ADVANZ PHARMA for commercialization in Europe and Canada, ensuring regional market penetration while outsourcing manufacturing to cost-effective partners[5]. Conversely, Sumitomo Dainippon Pharma relinquished rights to develop the drug in Japan and Korea but retained exclusivity in China, reflecting a focus on high-growth markets[7].
Regulatory and Patent Considerations
Patent Expirations and Generic Competition
Obeticholic acid’s composition-of-matter patent expired in 2023, triggering a surge in generic applications. Apotex Inc. and Msn Laboratories received FDA approval for 5 mg and 10 mg tablets in May 2023, undercutting Intercept’s branded pricing by 60%[13]. Despite this, formulation patents for dose-specific applications (e.g., NASH treatment) remain in force until 2030, creating a bifurcated market where generics compete only in non-protected indications[3][13].
Regulatory Hurdles for Emerging Suppliers
Suppliers in developing nations face challenges securing WHO prequalification or EU-Written Confirmations, which are prerequisites for tenders in Africa and Latin America[6][9]. For example, Bangladeshi exporters like Optimus Drugs Pvt Ltd have limited shipments to regional markets due to lacking CEP certifications, whereas Indian firms leverage their WHO-compliant facilities to supply 58% of global generic demand[6][9].
Market Dynamics and Pricing Trends
Demand Drivers and Therapeutic Expansion
The global obeticholic acid market, valued at $320 million in 2024, is projected to grow at a 6.8% CAGR through 2030, driven by rising PBC prevalence and off-label use in NASH[3][5]. Clinical trials investigating obeticholic acid for biliary atresia and severe alcohol-associated hepatitis further expand its addressable patient pool, with Phase III results expected by late 2025[3][7].
Pricing Disparities Across Regions
API pricing varies significantly by region:
- India and China: $6,000–$8,000/kg for generic-grade APIs[1][2]
- United States: $12,000–$15,000/kg for FDA-compliant material[4][10]
- Europe: €9,000–€11,000/kg for CEP-certified batches[5][9]
This disparity reflects differences in regulatory costs and profit margins, with European suppliers prioritizing premium pricing for high-purity APIs[5][9].
Supply Chain and Logistics Considerations
Export-Import Patterns and Trade Barriers
Volza’s trade data reveals 666 shipments of obeticholic acid between October 2023 and September 2024, with India accounting for 61% of exports[6]. Key corridors include:
- India → Bangladesh: 120 shipments (avg. 10 kg/month)
- China → Germany: 45 shipments (avg. 25 kg/month)
- U.S. → Canada: 18 shipments (avg. 50 kg/month)[6]
Tariff and non-tariff barriers, such as India’s 12% export duty on APIs, complicate logistics, prompting suppliers to reroute shipments through free-trade hubs like Singapore[6].
Cold Chain and Stability Challenges
Obeticholic acid’s thermolabile nature necessitates cold-chain logistics for long-distance transport. Suppliers in tropical regions like Vietnam face spoilage rates of 5–7%, whereas European manufacturers using lyophilized APIs report <1% wastage[6][9].
Clinical Developments and Future Outlook
Pipeline Applications and Market Expansion
Intercept Pharmaceuticals’ ongoing Phase III trial for biliary atresia (NCT04594694) could unlock a $200 million market by 2027 if approved[3]. Concurrently, combination therapies pairing obeticholic acid with bezafibrate show promise for PBC, potentially extending the drug’s lifecycle beyond generics[3][5].
Impact of Biosimilars and Next-Gen FXR Agonists
The emergence of biosimilars like INT-787 and novel FXR agonists threatens obeticholic acid’s market share. However, its established safety profile and low hepatotoxicity risk position it as a preferred first-line therapy in cost-sensitive markets[3][7].
Conclusion
The obeticholic acid supply chain is characterized by geographic specialization, regulatory stratification, and evolving competitive dynamics. While Indian and Chinese suppliers dominate volume production, U.S. and European manufacturers retain premium pricing power through quality differentiation. For stakeholders, diversifying supplier networks, securing long-term contracts with GMP-certified partners, and monitoring clinical developments will be critical to navigating this complex landscape. The interplay between generic entrants and indication-specific patents will further dictate market accessibility, making strategic agility a cornerstone of success.
"The global API market for obeticholic acid is poised for fragmentation, with regional suppliers leveraging cost advantages while innovators focus on therapeutic differentiation." – PharmaCompass Market Analysis[9]
References
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/obeticholic-acid
- https://m.chemicalbook.com/Manufacturers/obeticholic-acid.htm
- https://www.pharmaceutical-technology.com/data-insights/obeticholic-acid-intercept-pharmaceuticals-biliary-atresia-likelihood-of-approval/
- https://pharmaoffer.com/api-excipient-supplier/obeticholic-acid/united-states
- https://www.advanzpharma.com/news/2022/advanz-pharma-to-acquire-intercepts-business-in-europe-canada-and-all-other-markets-outside-of-the-u-s
- https://www.volza.com/p/obeticholic-acid/manufacturers/
- https://www.sumitomo-pharma.com/news/20180215-1.html
- https://www.tradeindia.com/manufacturers/obeticholic-acid.html
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/obeticholic-acid
- https://pharmaoffer.com/api-excipient-supplier/obeticholic-acid
- https://www.volza.com/p/obeticholic-acid/
- https://www.pharmacompass.com/us-drug-master-files-dmfs/obeticholic-acid
- https://pharsight.greyb.com/ingredient/obeticholic-acid-patent-expiration
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