The pharmaceutical giant Novo Nordisk is navigating a complex week, confronting issues in two major markets that highlight the pressures on its blockbuster drug franchise. Regulatory concerns in the United States coincide with a significant legal setback in India, testing the company’s operational and strategic resilience.
U.S. Supply Chain Infiltrated by Counterfeit Products
U.S. health regulators confirmed on Friday the seizure of dozens of counterfeit Ozempic units (Semaglutid 1 mg) that had entered the authorized supply chain. The Food and Drug Administration (FDA) specifically noted the number was in the “dozens,” alleviating some initial fears of a more widespread infiltration involving thousands of pens.
The fakes were identified bearing the batch number PAR1229, which is a legitimate Novo Nordisk number. The critical distinguishing feature is on the packaging: the counterfeit products display “EXP/LOT” to the left of the expiration date and lot number, whereas on authentic packages this information is placed above them. The company is collaborating with authorities to trace the source of this breach.
Indian Court Ruling Paves Way for Generic Competition
Simultaneously, the competitive landscape in India shifted following a judicial decision. The Supreme Court in New Delhi denied Novo Nordisk’s request for an interim injunction against Dr. Reddy’s Laboratories. This ruling carries specific implications:
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- Permitted: Dr. Reddy’s can now produce semaglutide in India and export it to countries where Novo Nordisk does not hold patent protection.
- Restricted: The sale of this generic version within the Indian domestic market remains prohibited until March 2026, when Novo’s relevant patent expires.
In a swift strategic response, Novo Nordisk announced it will officially launch Ozempic in India in December 2025—mere months before the patent cliff.
Setback in Neurological Drug Development
These market-specific challenges arrive following recent clinical disappointments. In late November, the Phase 3 trials EVOKE and EVOKE+ for an oral semaglutide formulation targeting early Alzheimer’s disease failed to meet their primary endpoint of slowing cognitive decline. This outcome has, for now, dashed hopes of expanding the company’s neurological treatment portfolio.
The focus remains squarely on safeguarding the core diabetes and obesity medication business. The supply chain incident, while described as limited in scale, represents a serious though rare event that could impact short-term market confidence. The Indian court decision exemplifies the mounting pressure from patent expirations that Novo Nordisk faces in key emerging markets.
Investors will likely monitor whether the confirmed limited scope of the counterfeit incident (“dozens” of units) sufficiently dispels concerns about systemic supply chain vulnerabilities. Meanwhile, March 2026 looms as the starting point for generic competition in one of the world’s most populous markets.
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