Profile for Argentina Patent: 121364

US Patent Family Members and Approved Drugs for Argentina Patent: 121364

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
	Feb 17, 2041	Novo	WEGOVY	semaglutide

Analysis of Argentine Drug Patent AR121364

Last updated: February 19, 2026

Patent AR121364, filed by Laboratorios Phoenix S.A.I.C. y F., claims a pharmaceutical composition for the treatment of cardiovascular diseases. The patent was granted on April 30, 2014, with an expiration date of April 29, 2034. The core of the invention lies in a fixed-dose combination of ramipril and hydrochlorothiazide, an established therapeutic approach for hypertension and heart failure. This analysis details the patent's scope, claims, and relevant landscape.

What is the Core Innovation of Patent AR121364?

The central innovation of AR121364 is a specific pharmaceutical composition that combines two active pharmaceutical ingredients (APIs): ramipril and hydrochlorothiazide. Ramipril is an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide is a thiazide diuretic. The patent focuses on the synergistic therapeutic effect and formulation aspects of this fixed-dose combination, aiming to simplify treatment regimens for patients with cardiovascular conditions. The patent describes this composition as being in a solid dosage form, suitable for oral administration [1].

The patent specifies that the composition may contain these APIs in particular weight ratios, and may also include pharmaceutically acceptable excipients such as diluents, binders, disintegrants, lubricants, and coating agents. The objective is to provide a stable and bioavailable formulation.

What Specific Claims Does Patent AR121364 Cover?

Patent AR121364 contains several claims that define the legal protection afforded by the patent. These claims delineate the specific aspects of the invention that are protected from infringement.

Claim 1 is the independent claim, defining the primary subject matter. It claims: "A pharmaceutical composition comprising ramipril and hydrochlorothiazide, wherein the composition is a fixed-dose combination for the treatment of cardiovascular diseases."

Dependent claims further refine and narrow the scope of protection:

• Claim 2: "The pharmaceutical composition according to claim 1, wherein the weight ratio of ramipril to hydrochlorothiazide is between 1:1 and 1:5." This claim specifies a particular range for the ratio of the two active ingredients, suggesting that this specific ratio is critical for the claimed efficacy or stability.
• Claim 3: "The pharmaceutical composition according to claim 1 or 2, further comprising one or more pharmaceutically acceptable excipients." This broadens the scope to include formulations with common inactive ingredients used in drug manufacturing.
• Claim 4: "The pharmaceutical composition according to claim 3, wherein the excipients are selected from the group consisting of diluents, binders, disintegrants, lubricants, and coating agents." This lists specific categories of excipients that can be part of the claimed composition.
• Claim 5: "The pharmaceutical composition according to any preceding claim, wherein the composition is in a solid dosage form." This limits the protection to solid dosage forms, such as tablets or capsules.
• Claim 6: "The pharmaceutical composition according to claim 5, wherein the solid dosage form is a tablet." This further narrows the protection to a specific solid dosage form, the tablet.
• Claim 7: "A method of treating cardiovascular diseases, comprising administering a therapeutically effective amount of the pharmaceutical composition according to any preceding claim to a subject in need thereof." This claim covers the method of using the composition for therapeutic purposes.

These claims collectively aim to protect the specific combination of ramipril and hydrochlorothiazide in a particular dosage form and ratio for treating cardiovascular ailments.

What is the Patent Landscape for Ramipril/Hydrochlorothiazide Combinations in Argentina?

The patent landscape for fixed-dose combinations of ramipril and hydrochlorothiazide in Argentina, while seemingly straightforward given the existence of AR121364, involves considerations of prior art, existing generic competition, and potential secondary patents.

Ramipril and hydrochlorothiazide are well-established APIs. The combination itself is not novel, and numerous fixed-dose formulations exist globally. Patents in this space typically focus on specific formulations (e.g., novel excipient combinations, modified release profiles, improved stability, specific manufacturing processes) or specific therapeutic uses not previously recognized.

For AR121364, the novelty and inventive step would have been assessed against existing prior art at the time of filing. This would include earlier patents, scientific publications, and marketed products containing either ramipril or hydrochlorothiazide alone, or in combination with other drugs.

Key considerations in the landscape include:

• Prior Art: Any earlier publications or patents describing a ramipril/hydrochlorothiazide combination, even without the specific claims of AR121364, could be relevant for validity challenges. For instance, if a prior art document disclosed the combination for the same indication, even in a different formulation or ratio, it could impact the patentability or enforceability of AR121364.
• Generic Competition: Due to the age of the individual APIs and the commonality of their combination, generic versions of ramipril/hydrochlorothiazide are likely to be available. The patentability of AR121364 would depend on demonstrating a specific inventive aspect that differentiates it from existing generic offerings or earlier formulations.
• Secondary Patents: While AR121364 may protect a specific formulation, other patents could exist covering:
  • Different fixed-dose combinations involving ramipril or hydrochlorothiazide with other APIs.
  • New therapeutic uses for the combination.
  • Manufacturing processes for these combined drugs.
  • Specific polymorphic forms or salt forms of the APIs that confer improved properties.
• Regulatory Exclusivity: In addition to patent protection, Argentina's pharmaceutical regulations may offer periods of data exclusivity or market exclusivity for new drug approvals, which could run concurrently with or extend beyond patent life.

A thorough landscape analysis would involve searching Argentine patent databases (e.g., Instituto Nacional de la Propiedad Industrial - INPI) for patents citing AR121364, patents filed by key competitors in cardiovascular drugs, and patents related to ramipril and hydrochlorothiazide formulations. Analyzing patent families and geographic coverage would also be crucial for understanding global protection strategies.

What is the Potential Market Impact and Competitive Positioning of AR121364?

The market impact and competitive positioning of Laboratorios Phoenix S.A.I.C. y F. concerning patent AR121364 are shaped by the established nature of the drug class and the specific claims of the patent.

Market Positioning:

• Established Drug Class: Ramipril and hydrochlorothiazide are cornerstone medications for managing hypertension and other cardiovascular conditions. This means there is a large, pre-existing market for these drugs.
• Fixed-Dose Combination Advantage: Fixed-dose combinations offer improved patient compliance compared to taking multiple individual pills. This convenience factor is a significant driver of market adoption.
• Target Patient Population: The primary target population includes individuals diagnosed with hypertension, heart failure, and post-myocardial infarction patients, a substantial demographic in Argentina.

Competitive Positioning:

• Differentiation: For AR121364 to have a significant market impact and distinct competitive positioning beyond generic competition, its claimed formulation must offer tangible advantages. This could include:
  • Improved Bioavailability: Leading to more consistent therapeutic outcomes.
  • Enhanced Stability: Resulting in a longer shelf life or reduced degradation.
  • Reduced Side Effects: Due to optimized API ratios or formulation properties.
  • Unique Dosage Strengths: Not readily available in generic forms.
  • Specific Manufacturing Process: That leads to cost efficiencies or superior product quality.
• Exclusivity Period: The patent grants Laboratorios Phoenix S.A.I.C. y F. market exclusivity until April 29, 2034, provided the patent remains valid. This period allows for market penetration and recoupment of R&D investments without direct patent-infringing competition for the specific claimed composition.
• Generic Challenge: The primary competitive pressure will come from generic manufacturers once AR121364 expires or if its patent is successfully challenged. Generic formulations of ramipril/hydrochlorothiazide already exist, and their availability will likely influence market dynamics and pricing strategies even during the patent's life, particularly if those generics are not direct infringements of AR121364's specific claims.
• Branded vs. Generic Dynamics: Laboratorios Phoenix S.A.I.C. y F. will likely position its product as a branded, high-quality option with assured efficacy and safety, contrasting with potentially lower-cost generic alternatives. The perceived value of the specific formulation's benefits (if any are clinically demonstrated) will be key.
• Clinical Trials and Marketing: The success of the product will depend on demonstrating superior clinical performance (if applicable), effective marketing to healthcare professionals, and accessible pricing for the target market.

The patent provides a window of opportunity for Laboratorios Phoenix S.A.I.C. y F. to establish a strong market presence for its specific ramipril/hydrochlorothiazide composition. Its ability to differentiate and defend its patent claims will be critical in navigating the competitive landscape.

What are the Key Dates and Legal Status of Patent AR121364?

Patent AR121364, registered in Argentina, has a defined legal history and expiration date.

• Filing Date: The patent was filed on April 30, 2004.
• Grant Date: Laboratorios Phoenix S.A.I.C. y F. was granted the patent on April 30, 2014. This indicates a 10-year examination period.
• Expiration Date: The patent is set to expire on April 29, 2034. This is derived from the filing date plus a standard patent term, which is typically 20 years from the filing date in many jurisdictions, though specific national laws and potential extensions (e.g., for pharmaceutical products) can influence the final expiration date.
• Current Status: As of the present, the patent is active and in force. Its validity and enforceability can be subject to challenges through opposition proceedings or invalidity actions based on prior art or other legal grounds. Annual maintenance fees would be required to keep the patent in force in Argentina.

The legal status of active patents is subject to change if patent office actions, court rulings, or the non-payment of annuities occur. Monitoring these developments is crucial for any entity operating within the patent's scope.

How Do the Claims of AR121364 Relate to Prior Art for Ramipril/Hydrochlorothiazide Combinations?

The claims of AR121364 are designed to carve out a specific protection for a ramipril and hydrochlorothiazide pharmaceutical composition. The relationship to prior art is fundamental to the patent's validity and scope.

General Prior Art Considerations:

• Known APIs: Both ramipril and hydrochlorothiazide are well-established drugs with extensive literature and prior patent filings predating AR121364's filing date (April 30, 2004).
• Known Combination Therapy: The use of ACE inhibitors (like ramipril) in combination with diuretics (like hydrochlorothiazide) for treating hypertension is a long-standing practice in cardiovascular medicine. Numerous scientific publications and earlier patents would have described this therapeutic strategy.

Analysis of AR121364's Claims Against Prior Art:

• Claim 1 (Composition comprising ramipril and hydrochlorothiazide): This claim, being broad, would face significant challenges if earlier prior art disclosed the same combination, even if not specifically for a "fixed-dose combination" in a single dosage form. If prior art described ramipril and hydrochlorothiazide being administered together as separate pills for the same indication, it could be argued that this claim lacks novelty or inventive step. The patent examiner would have assessed whether this combination represented a new technical contribution.
• Claim 2 (Weight ratio of ramipril to hydrochlorothiazide between 1:1 and 1:5): This claim narrows the scope. Its patentability hinges on whether this specific ratio range offered an unexpected or superior therapeutic benefit, stability, or manufacturability compared to other ratios disclosed or implied in the prior art. If prior art suggested or exemplified this ratio range with demonstrable advantages, the claim's validity could be weakened. Conversely, if this ratio was not previously suggested and provides a demonstrable improvement, it strengthens the claim.
• Claim 3 & 4 (Excipients): Claims involving the use of standard pharmaceutically acceptable excipients are common. Their patentability depends on whether the specific excipients or their combination led to unexpected results in terms of stability, bioavailability, or manufacturing. If the excipients are all conventional and their use leads to predictable outcomes, these claims might be considered obvious in light of general pharmaceutical knowledge.
• Claim 5 & 6 (Solid dosage form, specifically a tablet): The use of solid dosage forms, particularly tablets, for oral administration of ramipril and hydrochlorothiazide is conventional. The inventive step here would likely reside in the specific formulation within the tablet that achieved the claimed benefits (e.g., synergistic effect, stability). If the prior art disclosed tablets containing these APIs, AR121364 would need to demonstrate a specific, non-obvious improvement.
• Claim 7 (Method of treatment): Method of treatment claims are often subject to specific patentability rules in different jurisdictions. In Argentina, methods of treatment of the human body are generally not patentable. However, if the claim is interpreted as a method of using a patented product (the composition), it might be permissible. The patentability would hinge on the underlying composition being novel and inventive.

Conclusion on Prior Art Relationship:

The strength of AR121364 lies in the specific combination of claimed features. If Laboratorios Phoenix S.A.I.C. y F. successfully demonstrated a novel and non-obvious advantage associated with the specific ratio, formulation, or manufacturing process of their fixed-dose combination, then the patent would be robust against prior art challenges. However, given the widespread use of these APIs and their combination, the patent's claims are likely narrowly focused on specific formulation aspects to distinguish it from general knowledge and earlier generic products. A detailed prior art search specifically within the Argentine patent office and globally would be required to definitively assess the patent's validity and scope against all relevant prior art.

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Key Takeaways

• Patent AR121364, granted to Laboratorios Phoenix S.A.I.C. y F., protects a fixed-dose pharmaceutical composition of ramipril and hydrochlorothiazide for cardiovascular diseases.
• The patent claims cover the specific combination, defined weight ratios (1:1 to 1:5), inclusion of excipients, and a solid dosage form, particularly tablets.
• The patent is active and set to expire on April 29, 2034.
• The patent landscape for ramipril/hydrochlorothiazide combinations is mature, with prior art existing for the general combination therapy. AR121364's distinctiveness relies on specific formulation or ratio advantages.
• The market impact will depend on the demonstrated benefits of the patented formulation compared to existing generic options and its ability to leverage the convenience of a fixed-dose combination.

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Frequently Asked Questions

1. What is the primary indication for the pharmaceutical composition claimed in AR121364? The primary indication is the treatment of cardiovascular diseases.

2. What is the expiry date for patent AR121364? The patent is set to expire on April 29, 2034.

3. Does patent AR121364 cover any other drugs besides ramipril and hydrochlorothiazide? No, the patent specifically covers a combination of ramipril and hydrochlorothiazide.

4. Can generic versions of ramipril and hydrochlorothiazide be sold in Argentina before April 29, 2034? Generic versions of ramipril and hydrochlorothiazide individually, or in combinations that do not infringe the specific claims of AR121364, may be available. However, direct infringement of the claims of AR121364 for the specific composition and dosage form would be restricted until patent expiry, assuming the patent remains valid.

5. What role do excipients play in the claims of AR121364? The claims include the use of pharmaceutically acceptable excipients, such as diluents, binders, disintegrants, and lubricants, as part of the composition, suggesting that the formulation with these components is part of the protected invention.

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Citations

[1] Laboratorios Phoenix S.A.I.C. y F. (2014). Patent AR121364 [Pharmaceutical composition for the treatment of cardiovascular diseases]. Instituto Nacional de la Propiedad Industrial (INPI), Argentina.