In the fast-evolving pharmaceutical landscape, timing is everything. Whether you’re preparing a generic launch or defending an originator brand, understanding the full scope of patent and regulatory exclusivity can mean the difference between a missed opportunity and a strategic win.
At Saanvi Pharma Consulting, we help clients decode the complex layers of protection that surround pharmaceutical molecules — from country-specific patent rules to regulatory exclusivities — so they can move with confidence and precision.
🔍 Beyond the Patent Expiry: What You Might Be Missing
Public expiry dates are just the tip of the iceberg. Here’s what often lies beneath:
- A compound patent may expire, but formulation or method-of-use patents can still block entry.
- Regulatory exclusivities like SPCs, orphan drug extensions, and pediatric incentives can shift timelines by years.
- Claim language — broad, narrow, or ambiguous — affects both infringement risk and design-around strategies.
- Jurisdictional differences mean that a launch window in Germany may look very different from Canada or India.
- Some markets offer regulatory workarounds, while others enforce strict linkage systems.
đź“Š Data-Driven Insights
- Over 50% of top-selling drugs have secondary patents that extend protection by 5–10 years.
- In the EU, SPCs can add up to 5 years, plus 6 months for pediatric extensions.
- A 2025 study found that delayed generic entry for just four drugs (including Imatinib) led to €3.2 billion in excess spending across Germany, France, and Italy.
đź“‹ How We Evaluate Market Entry for Generics
Our strategic workflow includes:
- Baseline LOE Analysis Using INPADOC and national registers to identify compound patent expiry.
- Secondary Patent Mapping Reviewing formulation, polymorph, and method-of-use claims.
- Regulatory Exclusivity Review SPCs, orphan drug status, pediatric extensions — jurisdiction by jurisdiction.
- Claim Interpretation Assessing infringement risk and design-around potential.
- Jurisdictional Comparison Mapping exclusivity rules, litigation history, and launch windows.
- Entry Forecasting Aligning regulatory filings, manufacturing timelines, and commercial strategy.
🧠Questions We Help You Answer
- Can we launch in Germany before France?
- Is our formulation blocked by a method-of-use claim?
- What’s the earliest we can file without triggering litigation?
- Are there low-risk markets we’re overlooking?
These are the kinds of questions we help solve — with tailored patent searches, claim interpretation, and loss-of-exclusivity forecasting designed for pharma innovators and generic challengers alike.
💬 Let’s Talk
If you’re navigating patent cliffs, exclusivity layers, or strategic launch planning, we’re here to help. Contact Saanvi Pharma Consulting for expert guidance that blends regulatory insight with commercial foresight.
References
1. I-MAK. Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving Up Drug Costs. I-MAK Report, August 2018. Available from: https://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf
2. European Medicines Agency (EMA). Data Exclusivity – Glossary Entry. EMA Website, 2023. Available from: https://www.ema.europa.eu/en/glossary-terms/data-exclusivity
3. Health Action International. Generics Competition in the EU, US and Canada. HAI Report, December 2019. Available from: https://haiweb.org/storage/2019/12/Generics-competition-in-the-EU-US-and-Canada.pdf
4. World Intellectual Property Organization (WIPO). PATENTSCOPE Database: International Patent Search System. WIPO Website, 2025. Available from: https://www.wipo.int/en/web/patentscope
5. Cockburn, Iain & MacGarvie, Megan & MĂĽller, Elisabeth. Patent Thickets, Licensing and Innovative Performance. Industrial and Corporate Change. 2010.19. 899-925. 10.2139/ssrn.1328844.