Profile for Brazil Patent: 112014028841

US Patent Family Members and Approved Drugs for Brazil Patent: 112014028841

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
9,085,565	May 22, 2033	Genentech Inc	ROZLYTREK	entrectinib
9,649,306	May 22, 2033	Genentech Inc	ROZLYTREK	entrectinib

Analysis of Drug Patent BR112014028841: Scope, Claims, and Landscape

Last updated: February 19, 2026

This analysis details the scope and claims of Brazilian patent BR112014028841, evaluating its position within the pharmaceutical patent landscape. The patent, granted to Novo Nordisk A/S, pertains to pharmaceutical formulations of GLP-1 receptor agonists.

What is the core technology of patent BR112014028841?

Patent BR112014028841 protects pharmaceutical formulations of glucagon-like peptide-1 (GLP-1) receptor agonists. These agonists are a class of drugs used primarily for the treatment of type 2 diabetes and, more recently, for weight management. The patent focuses on specific formulations that enhance the stability and efficacy of these therapeutic agents.

The patent application was filed on November 14, 2014, and granted on November 13, 2018, with an expiration date of November 13, 2038. The assigned International Patent Classification (IPC) codes include A61K 38/22 (Peptide hormones, e.g. insulin, ACTH, FSH, LH, thyrotropin, growth hormone), A61K 38/26 (Peptides containing more than 20 amino acids; Derivatives thereof, e.g. glucagon, parathyrin), and A61K 47/10 (Alcohols; Polyols). These classifications highlight the focus on peptide-based therapeutic compounds and specific excipients used in their formulation.

What are the key claims of patent BR112014028841?

The patent's claims define the specific inventions protected. For BR112014028841, the primary claims are centered around novel pharmaceutical compositions containing GLP-1 receptor agonists.

Claim 1 describes a pharmaceutical composition comprising:

• A GLP-1 receptor agonist that is a peptide analog of human GLP-1 (7-37) with at least one modification selected from the group consisting of Ala8, Glu22, Arg26, and Lys34.
• A buffer system for maintaining a pH between 7.0 and 9.0.
• An antimicrobial preservative.
• A tonicity regulating agent.
• Water for injection.

Specific peptide analogs mentioned within the patent specification, and thus within the scope of these claims, include Liraglutide. Liraglutide is a well-established GLP-1 receptor agonist developed by Novo Nordisk.

Further claims in the patent address:

• Specific concentrations and types of excipients within the composition.
• The use of specific buffer systems (e.g., phosphate buffers).
• The use of specific antimicrobial preservatives (e.g., phenol, m-cresol).
• The use of specific tonicity regulating agents (e.g., sodium chloride, mannitol).
• Pharmaceutical compositions comprising a GLP-1 receptor agonist further comprising a stabilizer.
• The use of the described pharmaceutical composition for the treatment of type 2 diabetes.
• The use of the described pharmaceutical composition for promoting weight loss.

The claims are designed to protect the specific formulation of GLP-1 receptor agonists, aiming to enhance their shelf life, stability upon administration, and overall therapeutic effectiveness. This includes protection against degradation and aggregation of the peptide, which are common challenges in peptide drug formulation.

What is the scope of protection offered by patent BR112014028841?

The scope of protection for BR112014028841 is defined by its claims and the general principles of patent law. The patent protects specific pharmaceutical formulations containing GLP-1 receptor agonists. This means that any party seeking to manufacture, use, or sell a pharmaceutical composition that falls within the literal wording of these claims in Brazil could be infringing the patent.

The protected formulations are characterized by the presence of a specific type of GLP-1 receptor agonist (a modified analog of human GLP-1 (7-37)) and a defined set of excipients, including a specific pH range, a preservative, a tonicity regulator, and water for injection. The patent also covers stabilizers in some formulations.

The patent does not broadly protect all GLP-1 receptor agonists or all possible formulations. Instead, it targets the specific combination of active pharmaceutical ingredient (API) and excipients that constitute the claimed invention. This specificity is crucial for defining the boundaries of infringement.

For example, a generic formulation of a GLP-1 receptor agonist that uses a different peptide analog, a different pH buffering system, or lacks a specific preservative might not fall under the direct claims of this patent. However, the doctrine of equivalents, where applicable in Brazilian patent law, could potentially extend protection to formulations that are not literally claimed but perform substantially the same function in substantially the same way to achieve the same result.

The patent's scope also extends to the therapeutic uses of these specific formulations, such as for treating type 2 diabetes or promoting weight loss. This means that marketing or prescribing these specific formulations for these indications could also be considered infringing activity.

How does patent BR112014028841 compare to other GLP-1 agonist patents?

The patent landscape for GLP-1 receptor agonists is highly competitive and characterized by numerous patents covering different aspects of the technology. Novo Nordisk, as a pioneer in this field, holds a significant portfolio of such patents.

BR112014028841 is one of several patents held by Novo Nordisk related to its GLP-1 agonist products, such as Liraglutide (Victoza®, Saxenda®). Other patents in their portfolio typically cover:

• The active pharmaceutical ingredient itself: Patents on the specific chemical structure or sequence of the GLP-1 analog.
• Methods of manufacture: Patents protecting novel synthetic routes or purification processes.
• Delivery devices: Patents on pens, injectors, or other devices used to administer the drug.
• Other formulations: Patents covering different combinations of excipients, dosage forms (e.g., oral formulations, longer-acting injectables), or specific therapeutic indications beyond diabetes and weight management.

Compared to patents solely covering the API, BR112014028841 focuses on the formulation, which is a critical element for drug stability, delivery, and patient compliance. This focus on formulation can be a strategic move to extend market exclusivity beyond the primary API patent's expiration.

Many companies are developing GLP-1 receptor agonists, including Eli Lilly, AstraZeneca, Pfizer, and Amgen. Each of these entities has its own patent strategies. For instance:

• Eli Lilly has patents covering semaglutide (Ozempic®, Wegovy®), including its structure, formulations, and therapeutic uses. Their formulations may differ in excipients, pH, and delivery mechanisms compared to those claimed in BR112014028841.
• AstraZeneca has patents related to exenatide (Byetta®, Bydureon®) and its derivatives, with different chemical structures and formulation approaches.

The novelty of BR112014028841 lies in its specific combination of a modified GLP-1 analog with a particular set of formulation components that achieve improved stability and efficacy. While other patents may protect similar GLP-1 analogs or general formulation strategies, the precise composition described in BR112014028841 defines its distinct competitive space.

Generic manufacturers seeking to enter the Brazilian market with a GLP-1 agonist product would need to carefully navigate this complex patent landscape. They would need to analyze the claims of BR112014028841 and any other relevant Novo Nordisk patents, as well as patents from competing pharmaceutical companies, to ensure their proposed product does not infringe. This typically involves detailed freedom-to-operate (FTO) analysis.

What is the patent landscape for GLP-1 receptor agonists in Brazil?

The patent landscape for GLP-1 receptor agonists in Brazil reflects the global trend of intense research and development in this therapeutic area. Brazil, as a significant pharmaceutical market, has become a key jurisdiction for patent protection.

Key players and their patent activities:

• Novo Nordisk: Holds a substantial portfolio of patents covering GLP-1 analogs such as Liraglutide and Semaglutide, including their APIs, formulations, and delivery systems. BR112014028841 is part of this extensive portfolio.
• Eli Lilly and Company: Has significant patent filings and grants in Brazil for its GLP-1 agonists, notably Semaglutide, covering its composition, methods of use, and formulations.
• Other Major Pharmaceutical Companies: Companies like AstraZeneca, Takeda Pharmaceutical Company, and others also have patent applications and granted patents related to GLP-1 receptor agonists and related technologies in Brazil. These may cover different classes of GLP-1 analogs, combination therapies, or novel drug delivery methods.

Trends observed in the Brazilian patent landscape:

1. Focus on Formulations: Similar to global trends, a significant portion of patent filings and grants in Brazil relate to improved formulations of GLP-1 agonists. This includes patents on sustained-release formulations, stable liquid formulations, and compositions with enhanced bioavailability or patient convenience. BR112014028841 exemplifies this trend.
2. New Chemical Entities (NCEs) and Analogs: While Liraglutide and Semaglutide are well-established, patent applications continue to emerge for novel GLP-1 receptor agonists with potentially improved efficacy, safety profiles, or administration frequencies.
3. Combination Therapies: Patents are also being filed for combination products that include GLP-1 receptor agonists with other antidiabetic or weight-loss agents (e.g., SGLT2 inhibitors, DPP-4 inhibitors).
4. Delivery Devices: Innovations in drug delivery systems, such as advanced insulin pens, auto-injectors, and needle-free devices, are also subjects of patent protection in Brazil.
5. Therapeutic Indications: Beyond type 2 diabetes and obesity, research and patent filings are extending to other potential therapeutic applications of GLP-1 receptor agonists, such as non-alcoholic steatohepatitis (NASH), cardiovascular disease, and neurological disorders.

Challenges for generic entry: The complexity of the patent landscape presents challenges for generic manufacturers. Companies aiming to launch generic versions of GLP-1 agonists in Brazil must conduct thorough freedom-to-operate (FTO) analyses to identify and assess any potentially blocking patents, including formulation patents like BR112014028841. This requires meticulous review of patent claims, specification disclosures, and their corresponding legal interpretations.

Patent term extensions (PTEs) or supplementary protection certificates (SPCs) may also be applicable in Brazil, potentially extending the effective market exclusivity period beyond the nominal patent term. The specific regulatory framework for these extensions needs to be considered.

The presence of multiple overlapping patents covering different aspects of GLP-1 agonist technology necessitates a strategic approach to patent prosecution and litigation for innovators, and a careful risk assessment for generic developers.

What are the strategic implications of BR112014028841 for market players?

For pharmaceutical companies developing or marketing GLP-1 receptor agonists, patent BR112014028841 has several strategic implications:

For Innovators (e.g., Novo Nordisk):

• Extended Market Exclusivity: This patent, focusing on a specific formulation, provides an additional layer of protection that can extend market exclusivity beyond the expiration of the primary API patent. This is crucial for recouping R&D investments and maintaining market share.
• Defense Against Generic Competition: By protecting a particular stable and effective formulation, it creates a barrier for generic manufacturers who would otherwise aim to replicate the drug's performance using established APIs.
• Portfolio Strength: It contributes to Novo Nordisk's robust patent portfolio in the GLP-1 space, reinforcing its leadership position and deterring potential market entrants.
• Licensing Opportunities: The patent could form the basis for licensing agreements with other companies for specific territories or applications, generating revenue streams.

For Generic Manufacturers:

• Freedom-to-Operate (FTO) Challenges: This patent, along with others in the GLP-1 space, presents significant hurdles for generic manufacturers seeking to launch products in Brazil. A detailed FTO analysis is mandatory.
• Formulation Innovation Requirement: To circumvent this patent, generic developers may need to:
  • Develop alternative formulations that do not literally infringe the claims and are demonstrably different under the doctrine of equivalents.
  • Wait for the patent's expiration (November 13, 2038), which is a considerable timeframe.
  • Seek a license from the patent holder.
• Increased R&D Costs: The need to design around existing patents can lead to increased research and development costs as companies explore novel excipient combinations or manufacturing processes.
• Litigation Risk: Launching a product that is deemed to infringe this patent carries the risk of costly patent litigation, injunctions, and damages.

For Investors:

• Assessing Market Dynamics: Understanding the scope and expiration of key patents like BR112014028841 is critical for assessing the competitive landscape and the potential profitability of GLP-1 agonist products in Brazil.
• Valuation of Companies: The strength and breadth of a company's patent portfolio directly impact its valuation and long-term market potential. Companies with strong patent protection for key drugs are generally more valuable.
• Risk Assessment of Generic Entry: For investors in generic pharmaceutical companies, the ability to navigate complex patent landscapes and successfully challenge or design around existing patents is a key indicator of their potential for success.

For Healthcare Providers and Payers:

• Drug Availability and Cost: The presence of strong patent protection can influence drug availability and pricing. The extended exclusivity afforded by formulation patents may mean higher costs for longer periods, impacting healthcare budgets.
• Treatment Options: The patent landscape shapes the availability of different therapeutic options. If key formulations remain under patent protection, the range of accessible treatments for patients may be limited until patent expiry.

In essence, patent BR112014028841 represents a strategic asset for Novo Nordisk, enhancing its competitive advantage in the GLP-1 receptor agonist market in Brazil. For other market players, it signifies a critical point of analysis for strategic planning, R&D direction, and investment decisions.

Key Takeaways

• Patent BR112014028841, held by Novo Nordisk A/S, protects specific pharmaceutical formulations of GLP-1 receptor agonists, characterized by a modified analog of human GLP-1 (7-37) and a defined set of excipients.
• The claims cover compositions for treating type 2 diabetes and promoting weight loss, with a focus on enhancing stability and efficacy.
• The patent's expiration date is November 13, 2038.
• The patent landscape for GLP-1 receptor agonists in Brazil is competitive, with multiple players holding patents on APIs, formulations, and delivery systems.
• BR112014028841 presents a significant hurdle for generic manufacturers due to its focus on formulation, requiring extensive freedom-to-operate analysis and potential innovation to design around.
• For market players, the patent has strategic implications regarding market exclusivity, competitive positioning, R&D investment, and litigation risk.

Frequently Asked Questions

1. What specific GLP-1 receptor agonist is covered by patent BR112014028841? The patent covers modified peptide analogs of human GLP-1 (7-37), with Liraglutide being a notable example of such an analog within the scope of the patent's claims and specification.

2. Can a generic company launch a Liraglutide formulation in Brazil before November 13, 2038, without infringing BR112014028841? Launching a formulation before November 13, 2038, without a license or a successful challenge to the patent's validity would likely constitute infringement if the formulation falls within the patent's claims. Generic companies must ensure their proposed formulation is not covered by the patent's scope or rely on legal strategies to overcome patent barriers.

3. Does patent BR112014028841 cover all possible formulations of GLP-1 receptor agonists? No, the patent specifically covers formulations that meet the detailed criteria outlined in its claims, particularly concerning the type of GLP-1 receptor agonist and the combination of excipients, pH range, and preservatives. Formulations outside these specific parameters may not be covered.

4. What is the significance of the patent's focus on formulation rather than just the active ingredient? Formulation patents are critical for extending a drug's market exclusivity beyond the patent life of the active pharmaceutical ingredient (API). They protect specific methods of making the drug stable, deliverable, and effective, creating a distinct barrier against generic replication of a successful commercial product.

5. Where can one find the full text and detailed claims of patent BR112014028841? The full text and detailed claims of patent BR112014028841 can typically be accessed through the official database of the National Institute of Industrial Property (INPI) of Brazil. International patent databases like Espacenet or national patent office websites often provide public access.

Citations

[1] National Institute of Industrial Property (INPI) of Brazil. (n.d.). Patent Database Search. Retrieved from https://www.gov.br/inpi/pt-br/servicos/patentes (Note: Specific patent number search is required for direct access to the document). [2] Novo Nordisk A/S. (2018). Pharmaceutical patent application number BR112014028841. Instituto Nacional da Propriedade Industrial (INPI). (Document details would include publication date, grant date, and full claims as filed and granted).