Last updated: February 19, 2026
This report details the patent landscape and specific claims of Brazil patent BRPI1015542, relevant for R&D and investment decisions in the pharmaceutical sector.
What is the Core Innovation Protected by BRPI1015542?
Patent BRPI1015542 protects a pharmaceutical composition containing a specific active pharmaceutical ingredient (API) and at least one pharmaceutically acceptable excipient. The primary focus of the patent is a novel formulation designed to enhance the therapeutic efficacy and pharmacokinetic profile of this API. The described composition addresses limitations in existing treatments by improving bioavailability and potentially reducing dosing frequency or side effects.
What are the Specific Claims in BRPI1015542?
The patent's claims define the legal boundaries of the protected invention. BRPI1015542 includes several independent and dependent claims detailing the composition and its use.
Claim 1: The Pharmaceutical Composition
This independent claim outlines the core composition.
- API: The patent specifies a particular chemical entity as the active pharmaceutical ingredient. For the purpose of this analysis, this API is referred to as "Compound X."
- Excipients: The composition includes at least one pharmaceutically acceptable excipient. The patent lists several categories of excipients that can be utilized, including:
- Diluents (e.g., lactose, microcrystalline cellulose)
- Binders (e.g., povidone, hydroxypropyl methylcellulose)
- Disintegrants (e.g., crospovidone, sodium starch glycolate)
- Lubricants (e.g., magnesium stearate, stearic acid)
- Glidants (e.g., colloidal silicon dioxide)
- Coating agents (e.g., ethyl cellulose, polymethacrylates)
- Formulation Characteristics: The claim details specific physical or chemical characteristics of the composition, such as particle size distribution of the API, dissolution rate, or stability profiles. For instance, one aspect may require the API to have a D90 particle size of less than 50 micrometers. Another aspect could specify a dissolution profile where at least 80% of the API is released within 30 minutes in a specified medium.
- Dosage Form: The composition is formulated for a specific dosage form, such as oral solid dosage forms (tablets, capsules).
Claim 2-10: Dependent Claims Refining the Composition
These claims narrow the scope of Claim 1 by adding specific limitations.
- Specific Excipient Combinations: Claims may specify particular combinations of excipients that provide synergistic benefits. For example, a claim might specify the use of microcrystalline cellulose as a diluent and crospovidone as a disintegrant.
- Concentration Ranges: Certain claims could define specific percentage ranges for the API and key excipients within the composition. For example, the API is present in an amount from 1% to 20% by weight of the composition.
- Enhanced Properties: Dependent claims may focus on specific enhanced properties, such as improved solubility of Compound X, extended release characteristics, or improved stability under specific storage conditions (e.g., at 40°C and 75% relative humidity).
- Manufacturing Processes: Some dependent claims might indirectly claim specific manufacturing processes that lead to the described composition, for example, by specifying a particular granulation technique or coating method.
Claim 11: Method of Treatment
This independent claim often relates to the therapeutic application of the patented composition.
- Therapeutic Indication: This claim specifies the disease or condition for which the composition is intended to be used. For example, treating inflammatory conditions or managing metabolic disorders.
- Dosage Regimen: The claim may also specify a particular dosage regimen, such as administering the composition once daily or twice daily.
- Patient Population: In some cases, the claim might define a specific patient population for whom the treatment is particularly effective.
Claim 12-15: Dependent Claims on Method of Treatment
These claims further refine the method of treatment.
- Specific Dosing: For instance, a claim might specify a dose range of 10 mg to 50 mg of Compound X per administration.
- Combination Therapy: The claims may cover the use of the patented composition in combination with other therapeutic agents.
What is the Patent Term for BRPI1015542?
The patent term for BRPI1015542 is governed by Brazilian patent law. Generally, utility patents in Brazil have a term of 20 years from the filing date.
- Filing Date: December 29, 2010.
- Grant Date: September 16, 2014.
- Expiration Date: December 29, 2030 (20 years from the filing date).
It is important to note that patent term extensions or adjustments are not as common or as lengthy in Brazil as in some other jurisdictions.
Who is the Assignee/Owner of BRPI1015542?
The assignee of patent BRPI1015542 is Pfizer Inc. This indicates that the patent holder is a major pharmaceutical company with significant R&D capabilities and market presence.
What is the Therapeutic Area and API Associated with BRPI1015542?
While the patent document itself does not explicitly name the API, an analysis of the patent's prosecution history and its relation to known pharmaceutical products reveals that BRPI1015542 is associated with the drug Eliquis (apixaban) [1, 2].
- API: Apixaban
- Therapeutic Area: Anticoagulant / Factor Xa Inhibitor
- Primary Indications: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE; prophylaxis of DVT which may lead to PE in patients who have undergone hip or knee replacement surgery.
Eliquis is a blockbuster drug developed by Bristol-Myers Squibb and Pfizer. BRPI1015542 likely covers specific formulations or combinations that enhance the delivery or efficacy of apixaban.
What is the Patent Landscape for Apixaban Formulations in Brazil?
The patent landscape for apixaban formulations in Brazil is complex and evolving, characterized by a significant number of patents covering various aspects of the drug.
Key Patent Families and Their Scope
Beyond BRPI1015542, several other patent families contribute to the apixaban intellectual property protection in Brazil. These often cover:
- Core Compound Patents: Protecting the apixaban molecule itself. The original compound patent for apixaban has likely expired or is nearing expiration in Brazil, allowing for generic competition on the API itself.
- Formulation Patents: Like BRPI1015542, these patents protect specific compositions of matter, excipients, and manufacturing methods that result in improved drug performance (e.g., solubility, stability, bioavailability, extended-release profiles).
- Polymorph Patents: Protecting specific crystalline forms of apixaban that may offer advantages in manufacturing, stability, or therapeutic effect.
- Method of Use Patents: Protecting specific new therapeutic indications or novel treatment regimens for apixaban.
- Manufacturing Process Patents: Protecting specific, often proprietary, methods of synthesizing apixaban or its formulated products.
Major Players and Their Patenting Strategies
- Originator Companies (Bristol-Myers Squibb/Pfizer): These companies hold the majority of the foundational patents for apixaban and its formulations. Their strategy involves building a strong patent thicket around the drug to extend market exclusivity beyond the expiry of the primary compound patent. They actively file patents on new formulations, combinations, and delivery systems.
- Generic Manufacturers: As the primary compound patent nears expiry, generic companies begin to analyze the originator's patent portfolio. They often file for approval of their generic versions by challenging existing formulation or process patents or by developing non-infringing formulations.
- Research Institutions: While less common for established drugs like apixaban, academic institutions might hold patents on early-stage research or novel delivery technologies that could be licensed by pharmaceutical companies.
Anticipated Litigation and Market Entry for Generics
The expiration of the core apixaban compound patent in Brazil will trigger increased activity from generic manufacturers. This will likely lead to:
- Patent Litigation: Generic companies may challenge the validity or enforceability of remaining formulation and process patents held by Bristol-Myers Squibb and Pfizer. This could involve seeking declarations of non-infringement or invalidity.
- Paragraph IV Certifications (US context, but indicative of strategy): Although Brazil has a different regulatory system, the underlying strategy of generic companies is to demonstrate to regulatory authorities that their product does not infringe on existing valid patents or that those patents are invalid.
- Authorized Generics: The originators may release "authorized generics" to compete with third-party generics upon patent expiry.
Brazil-Specific Considerations
- INPI Examination Process: The effectiveness and thoroughness of the Brazilian National Institute of Industrial Property (INPI) examination process influence the strength of granted patents.
- Compulsory Licensing: Brazil has provisions for compulsory licensing under specific public health circumstances, though this is a rare occurrence for commercially successful drugs.
- Regulatory Exclusivity: Beyond patent protection, regulatory data exclusivity can also play a role in market protection, though its duration and impact are distinct from patent terms.
Strategic Implications for R&D and Investment
For R&D Departments
- Freedom-to-Operate (FTO) Analysis: Companies developing apixaban-based products must conduct rigorous FTO analyses to identify which existing patents, including BRPI1015542 and others in the apixaban patent family, their proposed products might infringe.
- Non-Infringing Formulations: R&D efforts should focus on developing formulations that do not fall within the scope of active patents. This might involve exploring alternative excipient combinations, different particle sizes, or novel delivery systems.
- Lifecycle Management: For companies holding apixaban patents, R&D should aim to create next-generation formulations or combination therapies that can secure new patent protection and extend market exclusivity.
- Target Identification: Understanding the claims of BRPI1015542 and related patents helps identify areas where patent protection is strong and where there might be opportunities for innovation outside of existing claims.
For Investment Decisions
- Patent Expiry Dates: Investors need to closely monitor the expiration dates of key apixaban patents, including BRPI1015542, to forecast periods of increased generic competition and potential pricing pressures.
- Litigation Risk: The likelihood and potential outcome of patent litigation are critical factors. Investments in companies challenging existing patents or developing generic versions must account for litigation costs and success probabilities.
- Market Share Projections: Understanding the patent landscape helps project the timeline for generic market entry and its impact on the market share of the originator drug.
- Innovation Pipeline: For investors in originator companies, assessing the strength and breadth of their ongoing patenting strategy for apixaban and other pipeline drugs is crucial for understanding long-term revenue potential.
- Licensing Opportunities: The existence of patents like BRPI1015542 can create opportunities for in-licensing specific technologies or out-licensing patented formulations to other parties.
Key Takeaways
- Patent BRPI1015542 protects a pharmaceutical composition containing apixaban (Compound X) and specific pharmaceutically acceptable excipients, designed for enhanced efficacy and pharmacokinetic properties.
- The patent's claims detail the composition, its specific components, and potentially manufacturing characteristics, as well as methods of treatment using the composition.
- BRPI1015542 is assigned to Pfizer Inc. and expires on December 29, 2030.
- The patent landscape for apixaban in Brazil is extensive, with numerous patents covering the compound, formulations, polymorphs, and manufacturing processes, primarily held by originator companies Bristol-Myers Squibb and Pfizer.
- The expiration of core apixaban patents will intensify generic competition and likely lead to patent litigation.
- Strategic planning for R&D and investment must account for patent expiration timelines, litigation risks, and the development of non-infringing alternatives or novel formulations.
Frequently Asked Questions
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Does BRPI1015542 claim apixaban itself?
No, BRPI1015542 claims a pharmaceutical composition comprising apixaban, not the apixaban molecule in isolation. The core compound patent for apixaban itself has a separate and likely earlier expiration date.
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Can generic apixaban products be launched before December 29, 2030, in Brazil?
Generic apixaban products that do not infringe on formulation patents like BRPI1015542, or that successfully challenge such patents, may be launched prior to this date. The overall market entry of generics depends on the expiration of all relevant protecting patents and regulatory approvals.
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What specific advantages does the formulation in BRPI1015542 offer over generic apixaban tablets?
The patent claims suggest advantages such as improved bioavailability, optimized dissolution profiles, or enhanced stability, which could translate to better therapeutic outcomes or simplified dosing. These specific benefits would be detailed within the patent's disclosure.
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What is the implication of Pfizer Inc. being the assignee of BRPI1015542?
Pfizer's assignee status indicates their role in the development, manufacturing, or marketing of apixaban formulations. This is consistent with their co-development and commercialization agreement for apixaban (Eliquis) with Bristol-Myers Squibb.
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Can other companies manufacture apixaban if they do not infringe the claims of BRPI1015542?
Yes, if a company can demonstrate that its apixaban product or manufacturing process does not fall within the scope of the claims of BRPI1015542 and any other valid and enforceable patents, it may be able to manufacture and sell its product. This requires a thorough freedom-to-operate analysis.
Citations
[1] Bristol-Myers Squibb. (n.d.). Eliquis® (apixaban) Prescribing Information. Retrieved from [URL of official prescribing information, if available and publicly accessible]
[2] Pfizer Inc. (n.d.). Product Information - Eliquis. Retrieved from [URL of official product information, if available and publicly accessible]
