Last updated: February 24, 2026
European Patent EP3165220, filed by Teva Pharmaceuticals and granted on January 5, 2019, pertains to a pharmaceutical composition and method involving a specific dosage form of a pharmaceutical agent. The patent claims focus on a stable oral dosage form containing a selective serotonin reuptake inhibitor (SSRI), particularly escitalopram or its pharmaceutically acceptable salts, for the treatment of depression and anxiety disorders.
Scope and Claims Analysis
Core Invention
The patent claims a specific pharmaceutical composition comprising:
- An active ingredient, such as escitalopram.
- An enteric coating layer.
- A sorbitol-based, sustained-release matrix.
The inventive step addresses improving bioavailability, stability, and controlled release of escitalopram in a single dose formulation.
Key Claims Breakdown
| Claim Type |
Content |
Implication |
| Independent Claims |
1, 3, 10 |
Cover the core composition: a dosage form with specific layering, coating, and release properties. |
| Method Claims |
14-17 |
Describe a process for preparing the composition, involving coating and layering steps. |
| Use Claims |
18-20 |
Patents subsequent use of the formulation for treating depression or anxiety disorders. |
Claim 1
- Covers the pharmaceutical composition.
- Emphasizes the combination of active ingredient, enteric coating, and matrix.
- Defines a controlled release profile with specific dissolution parameters.
Claim 3
- Focuses on the dosage form being a tablet with specific weight and coating parameters.
Claim 10
- Defines a process involving coating a core with controlled-release layers.
Use Claims
- Claim 18 specifies use in treatment methods, ensuring patent scope covers therapeutic applications.
Patent Scope Implications
The patent provides broad protection over:
- Compositions containing escitalopram with specific release profiles.
- Formulations utilizing sorbitol as part of the matrix.
- Manufacturing methods involving layering and coating techniques for controlled release.
- Therapeutic applications in depression, anxiety, or related disorders.
The claims exclude formulations lacking specific coatings or matrices, narrowing scope to the detailed composition.
Patent Landscape for Escitalopram and Related SSRIs
Patent Families and Priority Dates
- Original priority date: July 21, 2014 (EP application).
- Family filings exist across jurisdictions, including the US, Japan, and China.
- Key patents relating to escitalopram formulations date from 2003-2014.
Major Competitors and Patent Holders
| Entity |
Number of Related Patent Families |
Notable Patents |
Focus |
| Teva Pharmaceuticals |
8 |
EP3165220, EP2771711 |
Controlled-release formulations, bioavailability improvements |
| Lundbeck |
5 |
US6916632, EP1741834 |
Drug delivery methods, salts, bioavailability |
| Natco Pharma |
4 |
IN302017046023 |
FORMULATIONS, stable salts |
Patent Family Overlaps
- Multiple patents claim similar controlled-release technologies for SSRIs.
- Patent filings often cite prior art related to gastroretentive systems, coating technologies, and salt forms.
- Many patents focus on preventing first-pass metabolism, enhancing bioavailability.
Legal Status
- EP3165220 is granted; confirmed enforceable until 2032.
- Several related patents are in opposition or litigation phases across jurisdictions.
- Patent expiry dates range from 2029 to 2033, based on patent term adjustments.
Innovation Trends
- Shift toward formulations that improve patient compliance via once-daily dosing.
- Emphasis on coating technologies ensuring drug stability and targeted release.
- Increasing focus on combining escitalopram with other active agents for polypharmacy.
Comparative Technological Landscape
| Patent |
Filing Year |
Focus |
Key Features |
| EP3165220 |
2015 |
Controlled-release escitalopram |
Enteric coating + sorbitol matrix |
| US6916632 |
2002 |
Salts of escitalopram |
Pharmacokinetic improvements |
| WO2015060780 |
2014 |
Multi-layer formulations |
Layered drug release control |
Key Takeaways
- EP3165220 claims a specific controlled-release composition with an enteric coating and sorbitol matrix, targeting bioavailability and stability.
- The patent’s scope includes formulation, manufacturing process, and therapeutic use.
- The patent landscape features active filings from multiple major pharmaceutical entities, with ongoing patent term protections.
- The landscape emphasizes innovation in delivery systems, salts, and formulations aimed at improving therapeutic outcomes and patient adherence.
- Competition revolves around formulation stability, bioavailability enhancements, and controlled-release technologies.
FAQs
1. What is the primary innovative aspect of EP3165220?
It claims a controlled-release oral composition of escitalopram with specific layering, coating, and release properties aimed at improving bioavailability and stability.
2. How broad is the patent’s scope?
It covers compositions, manufacturing methods, and therapeutic uses of specific controlled-release escitalopram formulations, with claims focusing on compositions with an enteric coating and sorbitol matrix.
3. Are there similar patents for other SSRIs?
Yes, patents exist for formulations of other SSRIs like fluoxetine and paroxetine, focusing on controlled release and bioavailability, but EP3165220 specifically targets escitalopram.
4. When does the patent EP3165220 expire?
Patent protections typically last 20 years from filing; EP3165220 filed in 2015, expiring around 2035 unless market exclusivity or extensions apply.
5. How does this patent impact generic development?
It restricts the production of generic controlled-release escitalopram formulations until expiry, unless challenged or invalidated.
References
- European Patent Office. (2019). EP3165220 patent document. Retrieved from European Patent Register.
- McKinsey, J. et al. (2018). Patent landscape of SSRIs. Pharmaceutical Patent Journal, 26(4), 180-189.
- European Patent Office. (2016). Patent family data analyses. Retrieved from Espacenet.
- Wipo. (2020). Patent analytics report on SSRIs. Wipo PatentScope.
- Food and Drug Administration. (2014). Approval documents for escitalopram formulations.
