Suppliers and packagers for AUBAGIO

AUBAGIO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992	NDA	Genzyme Corporation	58468-0210-1	1 BLISTER PACK in 1 CARTON (58468-0210-1) / 5 TABLET, FILM COATED in 1 BLISTER PACK	2013-05-01
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992	NDA	Genzyme Corporation	58468-0210-3	1 BLISTER PACK in 1 CARTON (58468-0210-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK	2013-05-01
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992	NDA	Genzyme Corporation	58468-0210-4	1 BOTTLE in 1 CARTON (58468-0210-4) / 30 TABLET, FILM COATED in 1 BOTTLE	2013-05-01
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992	NDA	Genzyme Corporation	58468-0211-2	1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK	2013-05-01

Aubagio (Teriflunomide) Supplier Landscape: A Comprehensive Analysis of Pharmaceutical Manufacturing and Distribution

Last updated: April 19, 2025

Aubagio® (teriflunomide), a once-daily oral therapy for relapsing forms of multiple sclerosis (MS), has established itself as a critical treatment option since its approval in 2012. Developed and originally manufactured by Sanofi Genzyme, Aubagio’s supplier ecosystem has expanded significantly following patent expirations, enabling generic entrants and diversifying the global supply chain. This report examines the multifaceted supplier network for Aubagio, encompassing branded and generic manufacturers, active pharmaceutical ingredient (API) producers, and distribution channels, while analyzing market dynamics and regulatory considerations.

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Branded Manufacturing and Sanofi’s Role in Aubagio Production

Sanofi Genzyme, the specialty care division of Sanofi, remains the cornerstone of Aubagio’s branded production. The drug is manufactured at Sanofi’s state-of-the-art digital facility in Framingham, Massachusetts, which utilizes fully automated, paperless processes to enhance productivity and reduce environmental impact[1]. This facility, recognized for its innovation, supports Sanofi’s global distribution network, which includes 69 manufacturing sites across 32 countries[1].

Sanofi’s commitment to Aubagio is evident in its extensive clinical program, involving over 5,000 trial participants and real-world data from 110,000 patients[2]. Despite losing exclusivity in key markets, Sanofi continues to supply branded Aubagio, particularly in regions where generics are not yet approved. However, the company faced a 74% decline in Aubagio sales in Q4 2023 due to generic competition, underscoring the shifting market dynamics[6].

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Generic Teriflunomide Manufacturers and Market Penetration

The U.S. Food and Drug Administration (FDA) approved the first generic teriflunomide tablets in 2018, catalyzing a wave of market entrants. As of 2025, major generic suppliers include:

• Teva Pharmaceuticals: Approved in 2018 for 7 mg and 14 mg strengths[3].
• Natco Pharma: Received FDA clearance in May 2023[3].
• Sandoz: Entered the market in 2019 and expanded to 14 mg in 2020[3].
• Zydus Pharmaceuticals: Approved in 2018, leveraging its expertise in MS therapies[3].

These companies have capitalized on teriflunomide’s off-patent status, offering bioequivalent alternatives at significantly lower prices. For example, generic teriflunomide is available for $89.29 per 14 mg tablet compared to Sanofi’s branded version at $131.37[5]. This price disparity has driven rapid adoption of generics, particularly in cost-sensitive markets like Australia, where Alphapharm markets teriflunomide as Terimide[5].

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Active Pharmaceutical Ingredient (API) Suppliers and Production Networks

Teriflunomide API sourcing is critical to both branded and generic drug manufacturing. Key API suppliers include:

Primary API Manufacturers

1. Shilpa Medicare Ltd (India): A leader in API production with USFDA-approved facilities, supplying teriflunomide to multiple generic manufacturers[7][12].
2. PharmaZell (Germany): Provides high-purity teriflunomide API, adhering to European Medicines Agency (EMA) standards[7].
3. AXXO GmbH (Germany): Specializes in GMP-certified APIs for global distribution[7].
4. Sanofi (France): Maintains in-house API production for branded Aubagio, ensuring quality control[12].

Regional Suppliers

• Weijie Pharmaceuticals (China): Focuses on cost-effective API production for Asian markets[7].
• Biocon (India): Leverages fermentation technology to scale teriflunomide synthesis[7].

These suppliers operate under stringent regulatory frameworks, with certifications such as ISO 9001 and WHO-GMP ensuring compliance[12]. The teriflunomide API market is projected to grow at a 6.2% CAGR through 2030, driven by increasing MS prevalence and generic demand[13].

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Distribution Channels and Specialty Pharmacy Partnerships

Aubagio and its generics are distributed through a mix of authorized distributors and specialty pharmacies. Sanofi’s authorized network includes major pharmaceutical wholesalers such as Cardinal Health and McKesson, ensuring reliable supply to hospitals and clinics[9]. Specialty pharmacies like Accredo and CVS Specialty manage 90-day supplies for chronic MS patients, often coordinating with insurance providers to streamline access[8].

International distribution is facilitated by entities like North Drugstore, which sources branded Aubagio from New Zealand and generics from Australia, highlighting the globalization of the supply chain[5]. However, challenges persist, including counterfeit products from unverified online platforms, prompting regulatory warnings[3].

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Regulatory and Market Challenges

Patent Expirations and Competition

Sanofi’s loss of exclusivity in the U.S. (2023) and EU (2024) enabled generics to capture ~40% of the teriflunomide market by 2025[6]. This shift forced Sanofi to prioritize pipeline assets like tolebrutinib while maintaining Aubagio’s presence in pediatric MS, where it holds orphan drug exclusivity in the EU until 2026[2].

Pricing and Reimbursement Pressures

Generic entrants have reduced treatment costs by up to 60%, pressuring payers to favor teriflunomide over newer MS therapies[8]. In response, Sanofi offers patient assistance programs, though coverage remains fragmented in emerging markets.

Supply Chain Resilience

API production disruptions during the COVID-19 pandemic underscored reliance on Indian and Chinese suppliers. Companies like Shilpa Medicare and Natco Pharma have since diversified manufacturing sites to mitigate geopolitical and logistical risks[7][12].

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Future Outlook and Strategic Recommendations

The Aubagio supplier ecosystem is poised for further evolution. Key trends include:

• Biologics Competition: Monoclonal antibodies like ofatumumab may erode teriflunomide’s market share, necessitating cost reductions[10].
• Emerging Markets Expansion: Generic manufacturers are targeting regions with high MS incidence, such as Southeast Asia and Latin America.
• Sustainability Initiatives: Sanofi’s digital manufacturing model, which reduces carbon emissions by 30%, could set new industry standards[1].

Strategic Recommendations for Stakeholders:

1. Generic Manufacturers: Invest in clinical trials for pediatric MS to differentiate products.
2. API Suppliers: Adopt continuous manufacturing technologies to lower production costs.
3. Regulators: Strengthen oversight of online pharmacies to combat counterfeit teriflunomide.

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Key Takeaways

• Sanofi Genzyme remains a key supplier of branded Aubagio, supported by advanced manufacturing infrastructure.
• Generic teriflunomide is available from Teva, Natco, and Sandoz, driving affordability and market access.
• API production is concentrated in India and Germany, with rigorous quality controls ensuring global supply.
• Distribution relies on specialty pharmacies and authorized wholesalers, though counterfeit risks persist.

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FAQs

1. Is generic teriflunomide as effective as Aubagio?
   Yes, generics undergo rigorous bioequivalence testing to match the safety and efficacy of the branded product[3][8].

2. How does Sanofi ensure Aubagio’s supply chain reliability?
   Sanofi utilizes a global network of 69 manufacturing sites and digitalized production processes to mitigate disruptions[1][6].

3. Which countries are leading in teriflunomide API production?
   India and Germany dominate API manufacturing, with companies like Shilpa Medicare and PharmaZell leading output[7][12].

4. What are the risks of purchasing Aubagio online?
   Unverified pharmacies may distribute counterfeit products lacking therapeutic efficacy[3][5].

5. Will Aubagio remain relevant amid new MS therapies?
   Its oral administration and pediatric approvals ensure continued use, though market share may decline with biologic advancements[2][10].

“The European approval of Aubagio in pediatrics means young people with MS have a new treatment option, and importantly—one that can offer meaningful improvement in managing this serious disease.” – Sanofi Genzyme Representative[2]

Sources Cited
[1][2][3][5][6][7][8][9][10][12][13]

References

1. https://www.drugs.com/medical-answers/makes-aubagio-made-3561210/
2. https://www.sanofi.com/en/media-room/press-releases/2021/2021-06-18-13-45-00-2249701
3. https://www.drugs.com/availability/generic-aubagio.html
4. https://www.pharmacompass.com/manufacturers-suppliers-exporters/aubagio
5. https://www.northdrugstore.com/buy-aubagio.html
6. https://www.biospace.com/sanofi-hit-with-600m-net-loss-in-q4-amid-generic-competition
7. https://pharmaoffer.com/api-excipient-supplier/immunosuppressants/aubagio
8. https://www.medicalnewstoday.com/articles/drugs-aubagio-cost
9. https://www.sanofi.us/assets/dot-us/pages/images/contact-us/faq/Sanofi-U.S.-ADR-List-Update-as-of-August-2024.pdf
10. https://www.uhcprovider.com/content/dam/provider/docs/public/prior-auth/drugs-pharmacy/commercial/h-p/PA-Notification-MS.pdf
11. https://www.tosun-pharm.com/services/api-sourcing/
12. https://pharmaoffer.com/api-excipient-supplier/immunosuppressants/teriflunomide/iso9001
13. https://pmarketresearch.com/hc/linagliptin-tablets-market/teriflunomide-api-market