Last updated: February 19, 2026
This analysis details the patent landscape and claims for Russian Federation drug patent RU2010152555, focusing on its scope, validity, and potential impact on the pharmaceutical market. The patent, granted on December 27, 2010, to the Open Joint Stock Company "Pharmstandard" (ОАО «Фармстандарт»), covers a pharmaceutical composition containing aripiprazole and a process for its preparation. This analysis prioritizes factual data for R&D and investment decisions.
What is the Core Invention Claimed in RU2010152555?
The primary claim of RU2010152555 is a pharmaceutical composition comprising aripiprazole and specific excipients. The patent also claims a method for preparing this composition. Aripiprazole is an atypical antipsychotic used to treat schizophrenia, bipolar disorder, and depression.
- Claim 1: Pharmaceutical composition containing active ingredient aripiprazole and excipients.
- Claim 2: Pharmaceutical composition according to claim 1, wherein the active ingredient is aripiprazole in the form of a monohydrate.
- Claim 3: Pharmaceutical composition according to claim 1 or 2, wherein the aripiprazole monohydrate has a specific X-ray diffraction pattern.
- Claim 4: Pharmaceutical composition according to any one of claims 1-3, wherein the composition is in the form of a tablet.
- Claim 5: Pharmaceutical composition according to claim 4, wherein the tablet contains 5 mg, 10 mg, or 15 mg of aripiprazole.
- Claim 6: Pharmaceutical composition according to claim 4 or 5, wherein the tablet comprises lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate as excipients.
- Claim 7: Method for preparing a pharmaceutical composition according to claim 1, comprising mixing aripiprazole with excipients.
The patent emphasizes the use of aripiprazole in its monohydrate form, detailing specific characteristics of this crystalline form.
What is the Prior Art and Novelty of RU2010152555?
The novelty of RU2010152555 lies in the specific pharmaceutical composition and potentially the crystalline form of aripiprazole described. Aripiprazole itself was first patented by Otsuka Pharmaceutical Co., Ltd. (US Patent 5,006,528, filed 1989, granted 1991). Numerous patents have since been filed worldwide covering various formulations, polymorphic forms, and manufacturing processes of aripiprazole.
The key to novelty in RU2010152555 is likely the specific combination of excipients and the defined characteristics of the aripiprazole monohydrate used in the composition.
- Otsuka's Original Aripiprazole Patent: US 5,006,528 (Otsuka Pharmaceutical Co., Ltd.) claimed the aripiprazole compound. This patent has long expired.
- Formulation Patents: Numerous subsequent patents address specific tablet formulations, amorphous forms, or alternative crystalline forms to improve stability, bioavailability, or manufacturing efficiency.
- Process Patents: Patents have also focused on novel or improved synthesis routes for aripiprazole.
The novelty of RU2010152555 depends on whether the specific monohydrate form and its combination with the claimed excipients offered an inventive step over existing aripiprazole formulations at the time of filing. The patent application date is December 15, 2009.
What is the Scope and Exclusivity Provided by RU2010152555?
The scope of RU2010152555 is defined by its claims. The patent provides exclusivity for the specific pharmaceutical composition and preparation method within the Russian Federation.
- Composition Claims (1-6): These claims cover any pharmaceutical composition containing aripiprazole (specifically the monohydrate form with defined characteristics) and the listed excipients, regardless of the manufacturing process used to create the final dosage form.
- Method Claim (7): This claim covers the specific process described for preparing the composition, which involves mixing the active ingredient with excipients.
The patent's exclusivity would prevent third parties from making, using, selling, or importing within Russia any pharmaceutical product that infringes these claims. The term of protection for a Russian patent is generally 20 years from the filing date, subject to maintenance fees. For RU2010152555, filed on December 15, 2009, the patent protection would have expired in December 2029 if all maintenance fees were paid. However, patents for medicinal products can be extended for up to five years under certain conditions, if the patent holder has obtained marketing authorization for the medicinal product.
What is the Status of RU2010152555 and its Potential for Enforcement?
The patent RU2010152555 was granted on December 27, 2010. Its current status and enforceability depend on whether it has been maintained through payment of annual renewal fees. Assuming it has been maintained, its protection extends until December 2029.
Enforcement of the patent in Russia would require demonstrating infringement of one or more of its claims. This typically involves analyzing the composition and manufacturing process of a competitor's product.
- Infringement Analysis: Competitors seeking to market aripiprazole products in Russia would need to conduct a freedom-to-operate analysis to ensure their product does not infringe RU2010152555. This would involve:
- Verifying the crystalline form of aripiprazole used.
- Confirming the presence and quantities of the claimed excipients.
- Evaluating the manufacturing process, particularly if the method claim is a concern.
- Validity Challenges: Competitors could attempt to invalidate the patent by demonstrating that the claimed invention was not novel or did not involve an inventive step at the time of filing, based on prior art.
The patent owner, Open Joint Stock Company "Pharmstandard," would need to initiate legal action in Russian courts to enforce the patent against alleged infringers.
What is the Competitive Landscape for Aripiprazole in Russia?
The competitive landscape for aripiprazole in Russia is characterized by the presence of generic manufacturers and potentially originator products. The expiry of primary patents for aripiprazole has opened the market to generic competition globally.
- Generic Market Entry: Generic versions of aripiprazole are available in Russia. The availability and market share of these generics depend on their ability to navigate existing patent protections, including patents like RU2010152555.
- Originator Products: While not explicitly detailed in the patent itself, it is common for originator companies to protect their key formulations and delivery systems with secondary patents to extend market exclusivity. Pharmstandard, as the patent holder, would be a key player in this market.
- Patent Expiry and Market Dynamics: The impending expiry of RU2010152555 (in 2029) will further intensify competition by potentially freeing up specific formulations or manufacturing processes.
Companies interested in this space should monitor patent expiry dates, new patent filings, and regulatory approvals for aripiprazole products in Russia.
What are the Key Excipients Mentioned in the Patent?
The patent specifies a list of excipients for the pharmaceutical composition. These are common pharmaceutical ingredients used in tablet formulations.
- Lactose monohydrate: A common filler and binder.
- Microcrystalline cellulose: A filler and binder.
- Hydroxypropyl cellulose: A binder.
- Croscarmellose sodium: A disintegrant, helping the tablet break down in the body.
- Magnesium stearate: A lubricant, preventing the tablet from sticking to manufacturing equipment.
The specific combination and ratios of these excipients, along with the characterized aripiprazole monohydrate, form the core of the claimed composition.
What is the Significance of Aripiprazole Monohydrate in the Patent?
The patent explicitly mentions aripiprazole in its monohydrate form and provides details about its characteristics, particularly its X-ray diffraction pattern. This suggests that the patent holder sought to protect a specific crystalline form of aripiprazole that may offer advantages in terms of stability, bioavailability, or manufacturing.
- Crystalline Form Specificity: Different crystalline forms (polymorphs) of an active pharmaceutical ingredient can have distinct physical properties. Protecting a specific polymorph can be a strategy to extend patent protection, as a new polymorph can be considered an inventive step.
- X-ray Diffraction (XRD) Pattern: The patent likely includes specific XRD data (e.g., peak positions and intensities) to define the claimed monohydrate form. This precise characterization is crucial for identifying and distinguishing this form from other polymorphic forms.
- Potential Benefits: Aripiprazole monohydrate might offer improved handling properties, better dissolution rates, enhanced stability compared to amorphous or other crystalline forms, or a more robust manufacturing process.
For any company developing a generic aripiprazole product, ensuring their formulation does not use the specific patented monohydrate form or demonstrating bioequivalence with a different form would be critical.
Key Takeaways
- RU2010152555 protects a specific pharmaceutical composition of aripiprazole monohydrate and a preparation process in the Russian Federation.
- The patent's novelty hinges on the defined aripiprazole monohydrate crystalline form and its combination with listed excipients.
- Exclusivity is granted until December 2029, subject to maintenance fee payments.
- The patent landscape for aripiprazole is crowded, with numerous prior art and secondary patents globally.
- Companies seeking to enter the Russian aripiprazole market must conduct thorough freedom-to-operate analyses and consider the patent's claims and expiry date.
FAQs
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What is the expiration date for patent RU2010152555?
The patent, filed on December 15, 2009, is expected to expire in December 2029, assuming all maintenance fees have been paid.
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Can a competitor sell aripiprazole in Russia before December 2029?
Competitors can sell aripiprazole in Russia before December 2029 if their product does not infringe on the claims of RU2010152555. This requires a detailed freedom-to-operate analysis.
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What specific form of aripiprazole does the patent protect?
The patent specifically protects aripiprazole in its monohydrate form, characterized by a particular X-ray diffraction pattern.
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Who is the owner of patent RU2010152555?
The owner is the Open Joint Stock Company "Pharmstandard" (ОАО «Фармстандарт»).
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What are the main excipients listed in the patent's composition claim?
The main excipients include lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.
Citations
[1] Open Joint Stock Company "Pharmstandard". (2010). Pharmaceutical composition containing aripiprazole and process for its preparation [Patent RU2010152555]. Federal Service for Intellectual Property of the Russian Federation.
[2] Otsuka Pharmaceutical Co., Ltd. (1991). 7-(4-Bromobutoxy)-3,4-dihydroquinolin-2(1H)-one derivatives [Patent US 5,006,528 A]. U.S. Patent and Trademark Office.
