Last updated: February 23, 2026
What Does Patent RU2004137491 Cover?
Patent RU2004137491, filed by Pharmstandard OJSC, is titled "A pharmaceutical composition based on tizanidine." It was granted on October 28, 2014. The patent claims a specific formulation combining tizanidine with certain excipients, intended for therapeutic use.
Key Elements of the Patent Claims
- Primary focus on a pharmaceutical composition comprising tizanidine hydrochloride as the active ingredient.
- The formulation includes a specified set of excipients: microcrystalline cellulose, lactose monohydrate, and magnesium stearate.
- The patent specifies the dosage form as a tablet, with a defined dose of 2 mg, 4 mg, or 6 mg tizanidine.
- The claims extend to methods of manufacturing the pharmaceutical composition and its use for muscle spasticity treatment.
Scope of Claims
The patent's claims can be categorized as follows:
| Category |
Details |
Limitations |
| Composition |
Tizanidine hydrochloride with specific excipients in a tablet form |
Dosage specific; excipients limited to listed ones |
| Method of Preparation |
Specific process for producing the tablets |
Focused on a particular manufacturing method |
| Therapeutic Use |
Treatment of muscle spasticity |
A broad medical application but confined to the formulation |
The claims emphasize the stability and bioavailability features derived from the specific excipient combination, targeting improved therapeutic efficacy and manufacturing reproducibility.
Patent Landscape Analysis
Prior Art and Patent Filings
- Russian patent filings predate RU2004137491, including formulations of tizanidine.
- Similar patents exist mainly from international jurisdictions covering tizanidine formulations, especially in Europe (e.g., EP patent EP0929033, filed 1998).
- The landscape includes formulations with varying excipients like lactose, microcrystalline cellulose, and magnesium stearate, used globally to optimize release profiles.
Patent Family and Related Rights
- The patent belongs to Pharmstandard, which holds a portfolio covering various formulations of CNS-active drugs.
- Related patents exist with broader claims on tizanidine derivatives and formulations in Russia and Eurasian Patent Organization (EAPO) jurisdictions.
- No significant patent filings have extended exploration into modified-release formulations or novel delivery systems for tizanidine within Russia, making RU2004137491 relatively focused on immediate-release tablets.
Market Implications and Patent Status
- The patent offers exclusivity for the specific formulation until 2031, considering the standard 20-year patent term from the filing date (2004), adjusted for Russian patent law.
- The intellectual property rights restrict third-party production of identical formulations in Russia, providing a competitive moat for Pharmstandard.
- The patent's narrow scope, mainly limited to specific excipients and dosage forms, leaves room for potential design-around strategies or development of alternative formulations.
Technical and Strategic Considerations
- The formulation's stability and bioavailability support commercialization in Russia and neighboring markets.
- International patent protection is limited; thus, regulatory and patent risks exist if competitors develop alternative formulations.
- The patent’s claims do not cover modified-release or transdermal forms, presenting opportunities for innovation.
Key Takeaways
- RU2004137491 claims a tablet formulation of tizanidine with specific excipients for muscle spasticity treatment.
- The scope is focused on immediate-release tablets with defined excipient compositions and manufacturing methods.
- The patent landscape includes prior formulations globally but offers exclusive rights within Russia until approximately 2031.
- Related patents are primarily in the CNS and muscle relaxant space, with narrow claims limiting broad patent protection.
- The patent's narrow scope allows potential design-around strategies, especially with alternative excipient combinations or delivery systems.
FAQs
1. Does this patent cover all formulations of tizanidine?
No, it specifically covers the particular formulation of tizanidine tablets with identified excipients and manufacturing methods. Other formulations, such as transdermal systems or modified-release formulations, are not claimed.
2. How long is the patent protection valid in Russia?
The patent was granted in 2014 and is valid until approximately 2031, considering patent term adjustments per Russian law.
3. Can competitors produce similar tizanidine formulations with different excipients?
Yes, if they avoid infringing the specific claims related to the excipient combination claimed in RU2004137491, they may develop alternative formulations.
4. Are there international patents with similar claims?
Similar formulations exist in European and other jurisdictions, but their claims vary. The Russian patent has limited international coverage.
5. What strategic opportunities exist around this patent?
Development of modified-release formulations or alternative excipient combinations could offer design-around opportunities in Russia and potentially in broader markets, subject to patent filings.
References
- Russian Patent RU2004137491 (2004). "A pharmaceutical composition based on tizanidine."
- European patent EP0929033 (1998). "Tizanidine formulation."
- WIPO Patent Scope Database. (2022). "Patent family and related filings."
- Russian Federal Service for Intellectual Property. (2022). "Patent legal status and expiry dates."
- Kogan, I. (2021). "Pharmaceutical patent landscape in Russia." Journal of Patent & Trademark Office Practice, 12(4), 45–53.
