Suppliers and packagers for SAXENDA

SAXENDA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321	NDA	Novo Nordisk	0169-2800-15	5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTIC	2014-12-31
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321	NDA	Novo Nordisk	0169-2800-90	1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 3 mL in 1 SYRINGE, PLASTIC	2014-12-31
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321	NDA	Novo Nordisk	0169-2800-97	1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC	2014-12-31
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321	NDA	A-S Medication Solutions	50090-4257-0	5 SYRINGE, PLASTIC in 1 CARTON (50090-4257-0) / 3 mL in 1 SYRINGE, PLASTIC	2014-12-31

Comprehensive Analysis of Suppliers for the Pharmaceutical Drug Saxenda

Saxenda (liraglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, has emerged as a prominent medication for chronic weight management since its FDA approval in 2014[13]. Manufactured by Novo Nordisk, the drug’s global supply chain has faced significant challenges due to unprecedented demand, regulatory complexities, and regional distribution dynamics. This report examines the multifaceted supplier ecosystem for Saxenda, including primary manufacturers, regional distributors, pricing strategies, and recent developments shaping its availability.

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Novo Nordisk as the Primary Manufacturer

Development and Production of Saxenda

Novo Nordisk, a Denmark-based pharmaceutical company, holds exclusive manufacturing rights for Saxenda[3][13]. The drug’s active ingredient, liraglutide, is produced via recombinant DNA technology and formulated as a pre-filled, multi-dose pen for subcutaneous injection[4][16]. Saxenda’s production is centralized in Novo Nordisk’s facilities in Denmark, with significant investments in capacity expansion to address growing demand. In 2021, the company allocated $2.58 billion to construct new manufacturing sites and upgrade its Kalundborg complex, followed by an additional $2.3 billion in 2023 to enhance active pharmaceutical ingredient (API) production[2][7]. Despite these efforts, supply constraints persist due to the drug’s popularity and off-label use[2][9].

Patent Status and Generic Alternatives

As of April 2025, no therapeutically equivalent generic version of Saxenda is available in the U.S.[8]. However, Biocon Limited, an Indian biopharmaceutical firm, announced a semi-exclusive agreement with Medix in May 2024 to commercialize a vertically integrated generic liraglutide (gSaxenda) in Mexico[7]. This marks the first generic entry in a non-ICH country, targeting a $37 million addressable market[7]. Novo Nordisk retains patent exclusivity in major markets, though competitive pressures from Eli Lilly’s Mounjaro (tirzepatide) and its own Wegovy (semaglutide) have influenced strategic production shifts[2][9].

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Regional Distribution Networks

North America and Europe

In the U.S., Novo Nordisk distributes Saxenda through wholesalers like AmerisourceBergen and Cardinal Health, with retail pharmacies and online platforms such as K Health offering direct access[1][9]. The company’s savings card program reduces costs to $25 per 30-day supply for insured patients, though shortages have led pharmacies to prioritize existing users[1][2]. In Europe, Cloud Pharmacy in the UK provides Saxenda at £79.99 per pen, emphasizing follow-up care and alternatives like Wegovy[5].

Asia-Pacific Markets

India serves as a critical hub for Saxenda suppliers, with Novo Nordisk India Pvt Ltd producing pens priced at ₹2,100–₹6,500 ($25–$80) through distributors like Suraj Traders and Premier Medical Agency[6][14]. South Korea’s supply chain faced scrutiny in 2019 when Zuellig Pharma, Novo Nordisk’s exclusive distributor, was accused of antitrust violations for marginalizing smaller wholesalers[15]. Meanwhile, unauthorized smuggling of Saxenda into China—where it remains unapproved—highlighted cross-border demand disparities[12].

Latin America and Emerging Markets

Medix, a Mexican specialty pharmaceutical company, partnered with Biocon in 2024 to introduce gSaxenda, leveraging Novo Nordisk’s API production for regional affordability[7]. Brazil and Argentina rely on imports from Novo Nordisk’s Danish facilities, though tariffs and regulatory delays complicate accessibility[7][12].

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Supply Chain Challenges and Shortages

Demand Outpacing Production

Saxenda’s global sales surged by 52% in 2022, reaching $1.6 billion, driven by obesity epidemic trends and off-label prescriptions[2][10]. Novo Nordisk acknowledged in July 2023 that supply would remain constrained through 2024, attributing shortages to “demand increases at a substantial rate”[2][9]. Concurrently, competing GLP-1 agonists like Mounjaro and Ozempic faced similar bottlenecks, exacerbating scarcity[2][9].

Impact on Patients and Alternatives

Patients in the U.S. report difficulties refilling prescriptions, with the FDA categorizing Saxenda as “Limited Availability” through 2025[9]. Healthcare providers increasingly recommend transitioning to Wegovy or Zepbound, though these face their own supply limitations[9][11]. In response, Novo Nordisk prioritized higher-dose Wegovy pens (1.7mg/2.4mg) to retain existing users[2].

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Pricing and Cost-Saving Strategies

U.S. and European Pricing Models

Saxenda’s U.S. list price averages $1,349 per month, though insured patients pay as little as $25 via manufacturer coupons[1][9]. Uninsured individuals may access discounts up to $200 per prescription or utilize cost-comparison tools across pharmacies[1][5]. In the UK, Cloud Pharmacy offers bulk pricing at £374.99 for a five-pen supply, while EU markets enforce stricter price caps[5][6].

Emerging Market Affordability

Indian suppliers provide Saxenda at a fraction of Western costs, with generic liraglutide priced as low as ₹258 ($3) per unit[6][14]. Mexico’s gSaxenda initiative aims to reduce prices by 40%, aligning with public health goals to address obesity rates exceeding 70%[7].

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Legal and Regulatory Considerations

Antitrust and Distribution Disputes

Novo Nordisk’s exclusive partnership with Zuellig Pharma in South Korea sparked antitrust investigations in 2019, highlighting tensions between multinational manufacturers and local wholesalers[15]. Similarly, the U.S. FDA issued warnings against fraudulent online pharmacies selling counterfeit Saxenda, emphasizing risks of unregulated suppliers[8][10].

Litigation and Compliance

In 2023, Novo Nordisk faced lawsuits alleging inadequate disclosure of Saxenda’s side effects and promotional practices violating industry codes[10]. The company suspended direct-to-consumer advertising for Wegovy to mitigate demand spikes, reflecting broader regulatory pressures on GLP-1 agonists[2][10].

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Future Outlook and Strategic Expansions

Capacity Investments

Novo Nordisk’s $3.7 billion investment in Danish API facilities aims to double liraglutide output by 2026, aligning with projected obesity treatment market growth[2][7]. Biocon’s entry into Mexico signals potential for generic expansions in LATAM, though regulatory hurdles persist[7].

Digital Health Integration

Online platforms like Ro’s GLP-1 Supply Tracker and telemedicine services (e.g., K Health) are reshaping patient access, particularly during shortages[1][9]. These tools enhance transparency but require stringent oversight to prevent abuse[9][10].

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Conclusion

Saxenda’s supplier ecosystem reflects a delicate balance between innovation, demand, and regulatory compliance. Novo Nordisk remains the dominant player, yet partnerships with Biocon and regional distributors underscore efforts to broaden access. Persistent shortages and pricing disparities highlight systemic challenges in global pharmaceutical supply chains, necessitating coordinated strategies among manufacturers, regulators, and healthcare providers.

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“Our partnership with Biocon will bring quality and affordability into the pharmacological options for the physician, which supports our vision.” — Carlos Abelleyra, CEO of Medix [7]

References

1. https://khealth.com/prescription/saxenda-online/
2. https://www.fiercepharma.com/pharma/obesity-drug-shortage-expands-saxenda-novo-nordisk-warns-limited-supply-2023-and-beyond
3. https://www.novonordisk.co.nz/content/dam/nncorp/nz/en/pdfs/leaflets/Saxenda-cmi-v4.pdf
4. https://www.clinicaltrialsarena.com/projects/saxenda-liraglutide-obesity/
5. https://www.cloudpharmacy.co.uk/online-doctor/weight-loss-treatments/saxenda-weight-loss-pen/
6. https://dir.indiamart.com/impcat/saxenda-injection.html
7. https://www.biocon.com/biocon-limited-signs-semi-exclusive-distribution-and-supply-deal-for-the-commercialization-of-generic-saxenda-liraglutide-in-mexico-with-medix/
8. https://www.drugs.com/availability/generic-saxenda.html
9. https://ro.co/weight-loss/saxenda-shortage/
10. https://www.robertkinglawfirm.com/personal-injury/saxenda-lawsuit/
11. https://www.empr.com/home/news/supply-of-weight-loss-drug-saxenda-likely-limited-through-2023/
12. https://www.fiercepharma.com/pharma-asia/lured-by-high-demand-korean-wholesaler-smuggled-novo-s-obesity-med-to-china
13. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=36770
14. https://dir.indiamart.com/bengaluru/saxenda-injection.html
15. https://www.koreabiomed.com/news/articleView.html?idxno=4987
16. https://www.medsupplysolutions.com/product/saxenda-6mg-ml/