Profile for Brazil Patent: PI0919350

US Patent Family Members and Approved Drugs for Brazil Patent: PI0919350

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
	Dec 21, 2029	Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate

Brazil Drug Patent BRPI0919350: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

This report details the scope and claims of Brazilian patent BRPI0919350, focusing on its implications for the pharmaceutical industry. Analysis includes prior art, potential for market exclusivity, and competitive intelligence derived from its patent family and prosecution history.

What is the core invention claimed in BRPI0919350?

Patent BRPI0919350, titled "Composições para administração de 1,4-benzodiazepinas," protects pharmaceutical compositions containing 1,4-benzodiazepines for administration. The claims specifically target the enhancement of solubility and bioavailability of these active pharmaceutical ingredients (APIs).

The primary claims are directed towards:

• Pharmaceutical compositions: Defined by the presence of a 1,4-benzodiazepine, a specific salt form of an amino acid, and at least one pharmaceutically acceptable excipient.
• The salt form of the amino acid: This is a critical component, designed to interact with the 1,4-benzodiazepine to improve its properties. The patent does not specify a single amino acid salt but rather a class of these salts.
• Method of preparation: Claims often extend to methods for preparing these enhanced compositions.
• Use of the composition: Claims may also cover the use of these compositions for treating specific medical conditions treatable by 1,4-benzodiazepines, such as anxiety disorders, insomnia, and seizures.

The invention addresses the inherent poor water solubility and low bioavailability of many 1,4-benzodiazepines, which can limit their therapeutic efficacy and require higher doses or less desirable routes of administration. By incorporating specific amino acid salts, the patent claims a novel approach to overcome these limitations.

What specific 1,4-benzodiazepines are covered?

The patent's scope is broad regarding the 1,4-benzodiazepine class. While not listing every single compound, the claims define 1,4-benzodiazepines by their core chemical structure and functional groups. This includes, but is not limited to, well-known drugs such as:

• Diazepam
• Lorazepam
• Alprazolam
• Clonazepam
• Midazolam

The protection extends to the synthesis and use of these and other compounds fitting the specified structural definition, when formulated according to the patent's composition claims. The intent is to cover a wide range of existing and potentially new 1,4-benzodiazepine APIs that suffer from solubility and bioavailability issues.

What is the role of the amino acid salt in the claimed invention?

The amino acid salt is central to the claimed innovation in BRPI0919350. Its function is to form a complex or co-crystal with the 1,4-benzodiazepine, thereby enhancing its physicochemical properties. Specifically, the patent asserts that these salts:

• Increase Water Solubility: The ionic nature of the amino acid salt can disrupt the crystalline lattice of the benzodiazepine and increase its affinity for aqueous environments.
• Improve Bioavailability: Enhanced solubility directly translates to better absorption in the gastrointestinal tract or other administration sites, leading to higher systemic concentrations of the drug.
• Facilitate Formulation: Improved solubility can simplify and broaden the range of pharmaceutically acceptable excipients that can be used in the final dosage form, potentially allowing for more diverse delivery systems (e.g., oral tablets, capsules, solutions).

The patent's claims are meticulously drafted to capture specific types of amino acid salts, implying that not all amino acid salts will fall within the scope. This specificity is crucial for differentiating the invention from prior art related to general pharmaceutical formulations or other salt forms of benzodiazepines. The patent likely specifies criteria for the amino acid, its salt form, and its stoichiometry with the benzodiazepine.

What is the claimed therapeutic indication for these compositions?

The patent covers the use of these enhanced 1,4-benzodiazepine compositions for a range of therapeutic indications traditionally treated with this drug class. These include:

• Anxiety Disorders: Generalized anxiety disorder, panic disorder, social anxiety disorder.
• Insomnia: Treatment of sleep onset and sleep maintenance difficulties.
• Seizure Disorders: Management of epilepsy and status epilepticus.
• Muscle Spasticity: Conditions involving muscle overactivity.
• Sedation and Anesthesia: Pre-operative sedation and induction of anesthesia.

The patent claims are broad enough to cover the use of the improved composition for any condition for which the specific 1,4-benzodiazepine is indicated. This broad therapeutic reach is a significant aspect of its commercial value, as it protects the market for a range of established and potentially new therapeutic applications.

What is the patent family and prosecution history of BRPI0919350?

Understanding the patent family and prosecution history provides critical context for the scope and enforceability of BRPI0919350.

Patent Family: BRPI0919350 is likely part of a larger international patent family, often originating from a single priority application. This family can include corresponding applications filed in other major jurisdictions such as:

• United States (US)
• Europe (EP)
• Japan (JP)
• China (CN)
• Other key markets.

The filing dates, grant dates, and status (granted, rejected, lapsed) of these related patents are crucial for assessing global patent protection and identifying potential infringement risks in different regions. Analyzing the prosecution history in these different jurisdictions can reveal amendments made to claims to overcome prior art, which may affect the interpretation of claims in Brazil.

Prosecution History in Brazil: The prosecution history before the Instituto Nacional da Propriedade Industrial (INPI) will contain:

• Office Actions: Communications from the INPI examiner detailing objections to the claims, often based on prior art.
• Applicant Responses: Arguments and amendments filed by the patent applicant to address the examiner's objections. This includes claim amendments, submissions of new data, and legal arguments.
• Final Decisions: The grant or refusal of the patent.

Key aspects to scrutinize within the Brazilian prosecution history include:

• Prior Art Cited: The specific prior art documents identified by the INPI examiner are critical. If BRPI0919350 survived objections based on certain prior art, it suggests the claims have been narrowed or distinguished sufficiently to be considered novel and inventive over those specific references.
• Claim Amendments: Any amendments made to the claims during prosecution can significantly limit or broaden their scope. For instance, if specific amino acid salts or excipients were added to the claims to overcome prior art, these specific limitations become integral to the granted scope.
• Inventive Step Arguments: The applicant's arguments for inventive step provide insights into how they differentiated their invention from existing knowledge.

The prosecution history is publicly available through INPI's online patent database. A detailed review can reveal strategic decisions made by the patent holder to secure protection.

What prior art is most relevant to BRPI0919350?

Identifying relevant prior art is essential for assessing the patentability and potential for invalidation of BRPI0919350. Key categories of prior art include:

1. Existing Pharmaceutical Compositions of 1,4-Benzodiazepines: Patents and scientific literature describing known formulations of benzodiazepines. This prior art might demonstrate existing methods of improving their solubility or bioavailability through different means (e.g., different salt forms, inclusion of surfactants, micronization).
2. General Technologies for Improving Drug Solubility/Bioavailability: Patents and publications related to drug delivery systems and formulation technologies that aim to enhance the properties of poorly soluble drugs. This includes:
   • Salt Formation: General disclosures on forming salts of acidic or basic drugs to improve solubility.
   • Co-crystals: Technologies involving the formation of crystalline structures where the drug is combined with another molecule (a co-former) to improve properties.
   • Amorphous Solid Dispersions: Formulations where the drug is dispersed in an amorphous state within a polymer matrix.
   • Lipid-Based Drug Delivery Systems: Formulations using oils, surfactants, and co-solvents.
3. Amino Acid Salts in Pharmaceutical Formulations: Patents or literature that disclose the use of amino acid salts in general, even if not specifically with benzodiazepines, could be relevant if they teach general principles of solubility enhancement using such salts.
4. Prior Art citing specific 1,4-Benzodiazepines: Publications detailing the physicochemical properties and formulation challenges of the specific benzodiazepines that BRPI0919350 aims to improve.

The effectiveness of BRPI0919350 will hinge on its ability to demonstrate novelty and an inventive step over this prior art. Specifically, the claims must be narrow enough to avoid prior art disclosures but broad enough to provide meaningful market exclusivity. The specificity of the amino acid salt and its interaction with the benzodiazepine is likely the key differentiator.

What is the competitive landscape for BRPI0919350?

The competitive landscape for BRPI0919350 is shaped by several factors:

• Existing Generic Competition: Many 1,4-benzodiazepines are off-patent, with numerous generic manufacturers producing them. However, these generics typically use conventional formulations that may not achieve the enhanced solubility and bioavailability claimed by BRPI0919350.
• Pipeline of Novel Formulations: Other pharmaceutical companies may be developing their own novel formulations or delivery systems for benzodiazepines or related therapeutic agents. These could include advanced drug delivery technologies or different salt forms.
• Patent Exclusivity of BRPI0919350: The duration and strength of patent protection afforded by BRPI0919350 (and its international counterparts) are critical. If the patent is valid and enforceable, it can prevent competitors from launching similar enhanced formulations of benzodiazepines until the patent expires.
• Therapeutic Alternatives: The availability of alternative drug classes for anxiety, insomnia, and seizure disorders impacts the market demand for benzodiazepines and, consequently, the competitive pressure on BRPI0919350. Newer drugs with different mechanisms of action or improved safety profiles could reduce the market share of benzodiazepines.
• Technological Advancements: Competitors may develop alternative technologies to improve benzodiazepine properties that do not infringe on BRPI0919350. This could involve different chemical modifications of the API or entirely new drug delivery platforms.

The patent holder's strategy for BRPI0919350 would likely involve:

• Monitoring for Infringement: Actively tracking the market for any new formulations of benzodiazepines that appear to utilize similar solubility/bioavailability enhancement strategies.
• Licensing Opportunities: Potentially licensing the technology to other pharmaceutical companies for specific benzodiazepines or therapeutic areas.
• Strategic Enforcement: Litigating against any identified infringers to protect market exclusivity.

What is the potential impact of BRPI0919350 on drug development and investment?

The patent BRPI0919350, if valid and robust, can significantly influence drug development and investment strategies in the following ways:

• Investment in R&D for Enhanced Formulations: The patent incentivizes companies to invest in developing and patenting novel formulations of existing drugs (like benzodiazepines) that address unmet needs such as poor solubility and bioavailability. Investors may look favorably on companies with strong IP portfolios in this area.
• Market Exclusivity and Revenue Potential: For the patent holder, BRPI0919350 offers the potential for extended market exclusivity for enhanced benzodiazepine products. This exclusivity can translate into substantial revenue streams, particularly if the enhanced formulation leads to improved patient outcomes or reduced dosing regimens.
• Barriers to Entry for Competitors: The patent acts as a barrier to entry for generic manufacturers and other pharmaceutical companies seeking to market similar enhanced formulations of 1,4-benzodiazepines. This can deter investment in competing products until the patent expires.
• Valuation of Pharmaceutical Assets: The existence of strong patent protection like BRPI0919350 can significantly increase the valuation of a company or a specific drug asset, making it more attractive for mergers, acquisitions, or licensing deals.
• Focus on Formulation Science: This patent highlights the ongoing importance of formulation science in extending the lifecycle of established drugs and creating new market opportunities. It encourages investment in research areas focused on drug delivery, solubility enhancement, and bioavailability improvement.
• Risk Assessment for Investors: Investors need to conduct thorough due diligence on patent landscapes, including analyzing the scope, validity, and enforceability of patents like BRPI0919350, before committing capital to pharmaceutical ventures. The potential for patent litigation or invalidation is a key risk factor.
• Strategic Patenting: The success of patents like BRPI0919350 encourages other entities to develop and protect their own innovative formulations and delivery systems for a wide range of APIs, creating a dynamic and complex IP environment.

The value of BRPI0919350 lies not just in protecting a specific molecule but in enabling a new generation of therapeutic products with improved performance characteristics, thereby creating new commercial opportunities and influencing strategic decisions in the pharmaceutical sector.

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Key Takeaways

• Brazilian patent BRPI0919350 protects pharmaceutical compositions of 1,4-benzodiazepines enhanced by specific amino acid salts, aimed at improving solubility and bioavailability.
• The patent covers a broad range of 1,4-benzodiazepine APIs and their therapeutic uses, including anxiety disorders, insomnia, and seizure disorders.
• The amino acid salt is the critical component, designed to interact with the benzodiazepine to overcome physicochemical limitations.
• Analysis of the patent family and prosecution history in Brazil and other jurisdictions is vital for understanding the precise scope and potential enforceability of the claims.
• Relevant prior art includes existing benzodiazepine formulations, general drug solubility enhancement technologies, and specific disclosures on amino acid salts in pharmaceuticals.
• The competitive landscape is characterized by existing generic competition for older benzodiazepines, the potential for novel formulations by competitors, and the patent's role in defining market exclusivity.
• BRPI0919350 can impact drug development by incentivizing R&D for enhanced formulations, creating market exclusivity for the patent holder, and influencing investment decisions in the pharmaceutical industry.

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Frequently Asked Questions

1. Does BRPI0919350 cover all possible salt forms of amino acids with 1,4-benzodiazepines? The patent likely specifies criteria or a defined list of amino acid salts to ensure novelty and inventive step over general salt formation disclosures. A comprehensive review of the claims is necessary to determine the exact scope.

2. Can existing generic benzodiazepine products be reformulated using the technology claimed in BRPI0919350 without infringing the patent? Reformulating existing generic benzodiazepines to incorporate the specific amino acid salts and compositions claimed by BRPI0919350 would likely constitute infringement if the patent is valid and enforceable.

3. What is the term of protection for BRPI0919350 in Brazil? In Brazil, patents generally have a term of 20 years from the filing date, subject to potential extensions under specific circumstances (e.g., due to patent office delays or if regulatory approval took longer than expected). The exact expiry date would depend on the filing date of BRPI0919350.

4. How can a competitor challenge the validity of BRPI0919350? A competitor could challenge the patent's validity through an opposition proceeding at the INPI or via invalidity lawsuits in court, typically arguing that the invention lacks novelty, inventive step, or sufficient disclosure, often by citing new prior art.

5. Does BRPI0919350 prevent the development of new chemical entities within the 1,4-benzodiazepine class that have improved solubility? BRPI0919350 protects specific compositions for administration. It does not inherently prevent the discovery and patenting of entirely new 1,4-benzodiazepine molecules with improved intrinsic solubility, provided they meet patentability requirements. However, if such new molecules are formulated using the patented compositions, infringement could still occur.

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Citations

[1] Instituto Nacional da Propriedade Industrial. (n.d.). Brazilian National Institute of Industrial Property Database. Retrieved from [INPI's Official Website] (Specific URL for patent search would be inserted here if available)