Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

The Netherlands' pharmaceutical market is navigating a dynamic landscape marked by growth in branded drugs, regulatory evolution, and challenges in generic drug accessibility. Valued at XX million in 2025 with a projected 5.80% CAGR through 2033[1], the market is driven by an aging population, chronic disease prevalence, and technological innovation[1][5]. Here's an in-depth analysis:

Market Overview

Branded Drugs Dominate: Patented medicines accounted for 61% of the 2022 market ($4.31bn), while generics held 27% ($1.91bn)[6]. Major players like Pfizer, Novartis, and Johnson & Johnson lead this concentrated market (top 10 firms >60% share)[1].

Growth Drivers:

• Innovation Focus: Specialty drugs, biosimilars, and personalized medicine[1][5].
• Regulatory Hub: The EMA’s Amsterdam presence boosts R&D investment, with pharmaceuticals contributing 8% to industrial value[5].
• Patent Expiries: Key drugs like semaglutide (Ozempic) and pregabalin (Lyrica CR) face patent cliffs in 2025, opening opportunities for generics[3].

Forecast: Pharmaceutical sales are projected to rise from $6.49B PPP in 2024 to $6.72B PPP by 2028[7].

Generic Drug Challenges

Pricing Pressures:

• Low Price Ceilings: Generics enter at 25% of originator prices, falling to 40% within two years—far below the 80% seen in the U.S.[6].
• Shortages: Drug shortages surged 51% in 2023 (2,292 cases), with 68% linked to generics[2]. ABN AMRO argues raising price ceilings by 25% (costing €170M, 0.3% of healthcare spending) could mitigate this[2][6].

Regulatory Hurdles:

• Preference Policies: Insurers often select a single supplier via tenders, increasing shortage risks[2].
• Over-Regulation: Complex approval processes delay generics, despite bioequivalence standards[6][14].

Market Fragmentation: Generics face competition from OTC drugs and magistral compounding (e.g., CDCA for CTX patients, priced 25x lower than branded alternatives)[8].

Regulatory Opportunities

EU Policy Shifts:

• HTA Regulation (2025): Joint EU clinical assessments for oncology/ATMPs could streamline approvals[11].
• Pharma Package Reforms: Proposed EU legislation (targeting 2028–2029) aims to balance innovation and affordability[11].

National Initiatives:

• Small-Scale Experiments: The NZa’s 2025 framework encourages trialing innovations (e.g., telemedicine) under coverage-with-evidence programs[15].
• Generic Substitution: Dutch prescribers increasingly use INN names, with generics now >50% of prescriptions[10][13].

Strategic Considerations

For Branded Drug Makers:

• Focus on biosimilars and orphan drugs (e.g., CDCA Leadiant case[8]).
• Leverage EMA proximity for faster centralized approvals[4][12].

For Generics:

• Advocate for pricing reforms ([2] suggests matching Belgium/Germany’s 25% higher ceilings).
• Capitalize on 2025 patent expiries[3], though global API shortages remain a risk[6].

Policy Recommendations:

• Multi-Supplier Tenders: Avoid reliance on single suppliers to enhance resilience[2].
• EU-Wide Coordination: Address cross-border pricing disparities and API dependencies[2][6].

Future Outlook

While branded drugs drive innovation, generics’ growth hinges on resolving pricing and regulatory bottlenecks. The 2025–2030 period will test the Netherlands’ ability to balance cost containment with sustainable access, particularly as EU reforms reshape market dynamics.

"The large shortage of generic medicines is mainly caused by the fact that neighbouring countries pay 25% more for medicines."
— Anja van Balen, ABN AMRO Healthcare Sector Banker[2].

References

1. https://www.datainsightsmarket.com/reports/pharmaceutical-market-in-netherlands-7489
2. https://www.euractiv.com/section/health-consumers/news/netherlands-should-raise-generics-prices-to-combat-drug-shortages-says-dutch-bank/
3. https://www.drugpatentwatch.com/p/generic-entry-opportunity-date/Netherlands
4. https://english.cbg-meb.nl/sections/marketing-authorisation-medicines-for-human-use
5. https://think.ing.com/articles/dutch-manufacturing-comeback-2025/
6. https://pharmexcil.com/uploads/countryreports/Netherlands.pdf
7. https://www.reportlinker.com/dataset/cdd34a7caca3e84d5b179f88fd5db1bfc6cc15b3
8. https://www.pharmaceuticalaccountability.org/wp-content/uploads/2025/02/20250213-Verdict-Rotterdam-District-Court-in-Leadiant-vs-ACM_ECLI_NL_RBROT_2025_1811-ENGLISH-inofficial-translation.pdf
9. https://www.gabionline.net/country-focus/the-netherlands/Policies-and-Legislation
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC3107776/
11. https://www.aoshearman.com/insights/ao-shearman-on-life-sciences/key-regulatory-changes-impacting-the-healthcare-industry-in-the-eu-and-germany-in-2025
12. https://pubmed.ncbi.nlm.nih.gov/38679943/
13. https://gabionline.net/es/enfoque-por-pais/the-netherlands
14. https://www.gabionline.net/country-focus/the-netherlands/Licensing-Guidelines-and-Regulations
15. https://mtrconsult.com/news/dutch-healthcare-authority-updates-policy-framework-small-scale-experiments-2025