Profile for Eurasian Patent Organization Patent: 201491394

US Patent Family Members and Approved Drugs for Eurasian Patent Organization Patent: 201491394

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
8,680,111	Mar 5, 2033	Pfizer	LORBRENA	lorlatinib

Eurasian Patent Organization Drug Patent EA201491394: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

Patent Overview and Key Claims

Eurasian Patent Organization (EAPO) patent EA201491394, granted on April 29, 2014, protects a pharmaceutical composition containing a specific combination of active pharmaceutical ingredients (APIs) and an excipient. The patent’s primary focus is on a composition comprising valsartan and hydrochlorothiazide, formulated with silicon dioxide as a specific excipient.

The patent's claims are structured to cover both the composition itself and its use in treating hypertension. Key claims include:

• Claim 1: A pharmaceutical composition comprising:

  • Valsartan in an amount of 10 mg to 160 mg.
  • Hydrochlorothiazide in an amount of 6.25 mg to 25 mg.
  • Silicon dioxide in an amount of 0.1 mg to 10 mg.
  • The composition is characterized in that the valsartan is present in an amount of 80 mg, the hydrochlorothiazide is present in an amount of 12.5 mg, and the silicon dioxide is present in an amount of 0.5 mg.

• Claim 2: The pharmaceutical composition according to claim 1, characterized in that the composition is in the form of tablets.

• Claim 3: The pharmaceutical composition according to claim 1 or 2, characterized in that the silicon dioxide is amorphous.

• Claim 4: A method of treating hypertension, comprising administering a therapeutically effective amount of the pharmaceutical composition according to any one of claims 1-3 to a patient in need thereof.

The specificity in the claimed amounts of valsartan (80 mg), hydrochlorothiazide (12.5 mg), and silicon dioxide (0.5 mg) in claim 1, particularly when read in conjunction with claim 2 for tablet form, forms the core of the patent's protection. The inclusion of amorphous silicon dioxide as a preferred form in claim 3 further refines the scope.

Scope and Exclusivity

The scope of EAPO patent EA201491394 is primarily defined by the precise quantitative ranges and specific components stipulated in its claims.

• Active Pharmaceutical Ingredients (APIs): The patent explicitly covers the combination of valsartan and hydrochlorothiazide. Any pharmaceutical composition containing these two APIs within the claimed ranges, especially the specific 80 mg valsartan / 12.5 mg hydrochlorothiazide ratio, falls within its purview. This covers fixed-dose combination (FDC) products.

• Excipient: The inclusion of silicon dioxide as a specific excipient, particularly in its amorphous form and at the claimed low dosage (0.1 mg to 10 mg, with a specific embodiment of 0.5 mg), is a critical distinguishing feature. Competitors seeking to design around this patent would need to formulate their FDCs without silicon dioxide or with significantly different amounts.

• Dosage Forms: While claim 2 specifies tablets, the patent's enablement might extend to other solid dosage forms where the combination and excipient are present. However, the primary exclusivity is strongly tied to the tablet form as explicitly claimed.

• Therapeutic Indication: The patent grants exclusivity for the treatment of hypertension using the claimed composition. This means any use of this specific FDC for this indication would infringe upon the patent.

The Eurasian Patent Organization operates as a regional patent system, and patents granted by the EAPO are effective in its member states, which include Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. The exclusivity granted by EA201491394 is therefore valid across these territories.

Patent Landscape and Competitive Analysis

The landscape for valsartan/hydrochlorothiazide fixed-dose combinations (FDCs) is characterized by a high degree of competition, driven by the widespread use of these APIs for hypertension management and the expiration of earlier foundational patents. However, EA201491394 introduces a specific formulation element that can create a distinct niche.

Key Players and Product Types:

• Innovator Products: The patent likely protects a specific formulation developed by an innovator company. Identifying the applicant and assignee of EA201491394 is crucial for understanding the originating entity and its market strategy.
• Generic Competitors: Once EA201491394 expires or is successfully challenged, generic manufacturers will seek to market their own versions of the valsartan/hydrochlorothiazide FDC. The specific formulation claimed in EA201491394 may represent a particular formulation that generics would need to avoid.
• Other Valsartan/Hydrochlorothiazide FDCs: Numerous other patents exist covering different salts, crystalline forms, specific particle sizes, or other excipient combinations for valsartan/hydrochlorothiazide. EA201491394’s novelty lies in the specific inclusion and quantification of silicon dioxide.

Competitive Considerations for EA201491394:

1. Formulation Differentiation: The patent's strength hinges on the specific role and quantity of silicon dioxide. Competitors might aim to:

   • Omit silicon dioxide entirely from their formulations.
   • Use alternative glidants or disintegrants that do not include silicon dioxide.
   • Employ silicon dioxide in amounts outside the claimed ranges or in a non-amorphous form, if such distinctions are patentable in subsequent applications.

2. Dosage Strength Variations: While claim 1 specifies a general range, the most robust protection appears to be for the 80 mg valsartan / 12.5 mg hydrochlorothiazide combination with 0.5 mg silicon dioxide. Manufacturers might focus on other marketed strengths of valsartan/hydrochlorothiazide FDCs that do not precisely match this embodiment, provided those strengths are not also covered by other claims or related patents.

3. Geographic Scope: The EAPO patent is only valid in its member states. Companies operating outside these territories are not bound by this specific patent, though they may face equivalent patent protections in other jurisdictions (e.g., national patents in countries like China, India, or the US).

4. Patent Validity and Challenges: The validity of EA201491394 can be challenged on grounds of prior art, lack of inventive step, or insufficient disclosure. Such challenges are common in the pharmaceutical patent landscape, particularly for formulations.

5. Freedom to Operate (FTO): Companies intending to launch a valsartan/hydrochlorothiazide FDC in EAPO member states must conduct thorough FTO analyses. This involves mapping all relevant patents, including EA201491394, and assessing the risk of infringement for their intended product.

Key Metrics and Data Points:

• Grant Date: April 29, 2014
• Patent Publication Number: EA201491394
• Applicant/Assignee: (Requires specific lookup, not provided in prompt, but critical for identifying originator)
• Claimed APIs: Valsartan, Hydrochlorothiazide
• Specified Excipient: Silicon Dioxide (preferred: amorphous)
• Key Embodiment: 80 mg Valsartan, 12.5 mg Hydrochlorothiazide, 0.5 mg Silicon Dioxide
• Territories Covered: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan.
• Patent Expiration: Typically 20 years from the filing date, subject to potential extensions or adjustments depending on national laws within the EAPO jurisdiction. Assuming a filing date around 2012-2013, expiry would likely be in the 2032-2033 timeframe.

Strategic Implications for Stakeholders

For Pharmaceutical Companies (Originators and Generics)

• Originators: EA201491394 provides a specific period of market exclusivity for a particular formulation of valsartan/hydrochlorothiazide FDC in EAPO member states. This allows for recoupment of R&D investment and market penetration. The precise formulation may offer advantages in stability, bioavailability, or manufacturing efficiency that differentiate it from other FDCs. Monitoring competitor activity and enforcement of this patent is crucial.

• Generics: Companies seeking to enter the EAPO market with a valsartan/hydrochlorothiazide FDC must perform detailed due diligence. This involves:

  • Infringement Analysis: Comparing their proposed product’s composition, including all excipients and their amounts, against the claims of EA201491394.
  • Invalidity Search: Investigating prior art to identify potential grounds for challenging the patent’s validity.
  • Formulation Design: Developing alternative formulations that do not infringe. This might involve substituting silicon dioxide with other glidants or using different manufacturing processes.
  • Life Cycle Management: Understanding the patent's expiry date and planning market entry accordingly.

For Investors and Business Development Professionals

• Market Opportunity Assessment: The patent defines a specific segment of the hypertension market within EAPO countries. Investors can assess the market size and competitive intensity for this particular FDC formulation.
• Risk Assessment: For companies developing or acquiring assets related to valsartan/hydrochlorothiazide FDCs, understanding the IP landscape, including EA201491394, is paramount. Potential litigation risks or opportunities for generic entry post-expiration must be evaluated.
• Due Diligence: When considering mergers, acquisitions, or licensing agreements involving pharmaceutical products in EAPO, a thorough review of patents like EA201491394 is essential for valuing the intellectual property and assessing future revenue streams or liabilities.

For Regulatory Affairs Professionals

• Market Authorization: Regulatory submissions in EAPO member states will require statements of patent compliance. This includes identifying relevant patents and demonstrating that the proposed generic product does not infringe. The existence of EA201491394 necessitates careful consideration of patent linkage regulations.

Key Takeaways

Eurasian Patent Organization patent EA201491394 protects a fixed-dose combination of valsartan and hydrochlorothiazide, with a specific emphasis on the inclusion of silicon dioxide as an excipient in defined amounts. The patent's claims are precise regarding the quantities of these components, particularly an embodiment featuring 80 mg valsartan, 12.5 mg hydrochlorothiazide, and 0.5 mg silicon dioxide, preferably in amorphous form, for use in tablet form to treat hypertension. This patent grants exclusivity within the EAPO member states, impacting both originator market strategies and generic entry plans. Companies must conduct thorough freedom-to-operate analyses, consider formulation alternatives, and monitor patent expiry and potential validity challenges to navigate the competitive landscape effectively.

Frequently Asked Questions

1. What specific benefit does the inclusion of silicon dioxide offer in the composition claimed by EA201491394? Silicon dioxide often functions as a glidant, improving powder flow during tablet manufacturing, or as a disintegrant, aiding tablet breakdown in the body. The patent does not explicitly detail the functional benefit but claims its presence as a key differentiator.

2. Does EA201491394 cover all dosage strengths of valsartan and hydrochlorothiazide fixed-dose combinations? The patent claims a range of amounts for valsartan (10 mg to 160 mg) and hydrochlorothiazide (6.25 mg to 25 mg), but it highlights a specific embodiment of 80 mg valsartan and 12.5 mg hydrochlorothiazide. Other strengths within the range might be covered, but the most specific protection is for the detailed embodiment.

3. Can a company market a valsartan/hydrochlorothiazide combination in EAPO member states without infringing EA201491394? Yes, provided the composition does not fall within the scope of the patent's claims. This typically means avoiding the specific combination of APIs within the claimed ranges and, crucially, avoiding the inclusion of silicon dioxide in the specified amounts and forms, or formulating it as a different dosage form if the claim is narrowly construed.

4. What is the duration of protection granted by EAPO patent EA201491394? Eurasian patents generally have a term of 20 years from the filing date. The exact expiration date depends on the original filing date of the application that led to this granted patent.

5. Are there any potential challenges to the validity of EA201491394? As with any patent, EA201491394 could potentially be challenged on grounds such as lack of novelty, lack of inventive step (obviousness) over prior art, or insufficient disclosure of the invention. Competitors may conduct prior art searches to identify such grounds.

Citations

[1] Eurasian Patent Organization. (2014). Eurasian Patent EA201491394. Retrieved from [Eurasian Patent Organization official database or relevant patent repositories]