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Last Updated: April 22, 2025

CAPOZIDE 25/15 Drug Patent Profile


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Which patents cover Capozide 25/15, and what generic alternatives are available?

Capozide 25/15 is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in CAPOZIDE 25/15 is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.

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Summary for CAPOZIDE 25/15
Drug patent expirations by year for CAPOZIDE 25/15
Recent Clinical Trials for CAPOZIDE 25/15

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SponsorPhase
GlaxoSmithKlinePhase 1

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US Patents and Regulatory Information for CAPOZIDE 25/15

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Apothecon CAPOZIDE 25/15 captopril; hydrochlorothiazide TABLET;ORAL 018709-001 Oct 12, 1984 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Expired US Patents for CAPOZIDE 25/15

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Apothecon CAPOZIDE 25/15 captopril; hydrochlorothiazide TABLET;ORAL 018709-001 Oct 12, 1984 4,105,776 ⤷  Try for Free
Apothecon CAPOZIDE 25/15 captopril; hydrochlorothiazide TABLET;ORAL 018709-001 Oct 12, 1984 4,217,347 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 2 of 2 entries

International Patents for CAPOZIDE 25/15

See the table below for patents covering CAPOZIDE 25/15 around the world.

CountryPatent NumberTitleEstimated Expiration
Australia 1955476 ⤷  Try for Free
Austria A98977 ⤷  Try for Free
Austria A39380 ⤷  Try for Free
Norway 763820 ⤷  Try for Free
Switzerland 642542 ARZNEIMITTEL, ENTHALTEND EINE KOMBINATION AUS EINEM PROLINDERIVAT UND EINEM DIURETIKUM. ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory for CAPOZIDE 25/15

Introduction

CAPOZIDE 25/15, a combination of captopril and hydrochlorothiazide, is a widely used antihypertensive medication. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers.

Mechanism and Uses

CAPOZIDE combines an ACE inhibitor (captopril) and a thiazide diuretic (hydrochlorothiazide), making it effective for treating hypertension. The blood pressure lowering effects of these components are approximately additive, allowing for flexible dosing strategies[1].

Market Position

Generic Drug Market

CAPOZIDE, being a generic drug, operates within a highly competitive market. The generic drug industry is characterized by mid-single-digit percent annual price erosion, but it is expected to see modest revenue growth in 2024. This trend suggests that while prices may decrease, the overall demand for generic drugs, including CAPOZIDE, is likely to remain stable or grow slightly[3].

Competition and Pricing

The pharmaceutical industry, particularly the generic segment, faces intense competition. Price-fixing litigation and increased FDA inspections of foreign manufacturing facilities are potential risks that could impact the pricing and availability of CAPOZIDE. However, these factors also drive innovation and compliance, which can stabilize the market in the long run[3].

Prescription Trends and Usage

Prescription Volume

The use of medicines in the United States has been on the rise, with Americans filling 5.8 billion prescriptions in 2018, a 2.7% increase from the previous year. While CAPOZIDE is not specifically highlighted in these statistics, the overall trend indicates a growing demand for antihypertensive medications. Given its efficacy and tolerability, CAPOZIDE is likely to benefit from this trend[4].

Patient Out-of-Pocket Costs

Patient out-of-pocket costs for prescriptions have been a significant concern. However, the use of manufacturer coupons and other cost-offsetting strategies has helped manage these costs. For CAPOZIDE, being a generic drug, the out-of-pocket costs are generally lower compared to branded drugs, making it more accessible to patients[4].

Clinical Efficacy and Patient Response

Clinical Trials

Clinical trials have shown that CAPOZIDE is effective and well-tolerated in various patient populations, including black patients with mild to moderate essential hypertension. Studies have demonstrated that patients respond equally well to different doses of CAPOZIDE, with significant reductions in blood pressure observed[5].

Patient Compliance

The efficacy and tolerability of CAPOZIDE contribute to high patient compliance. Since it can be taken once daily and has a favorable side effect profile, patients are more likely to adhere to their treatment regimen, which can lead to better health outcomes and reduced healthcare costs in the long term.

Financial Trajectory

Revenue Growth

The revenue growth for CAPOZIDE is influenced by the broader trends in the generic drug market. While price erosion is a challenge, the increasing demand for antihypertensive medications and the stable market position of CAPOZIDE suggest modest revenue growth. The pharmaceutical industry's overall net spending is projected to increase from $344 billion in 2018 to $420 billion in 2023, with generic drugs playing a significant role in this growth[4].

Cost and Pricing Strategies

The financial performance of CAPOZIDE is also influenced by cost and pricing strategies. Given the competitive nature of the generic drug market, manufacturers often engage in pricing strategies that balance revenue goals with patient affordability. This may include discounts, rebates, and other incentives to maintain market share.

Regulatory Environment

FDA Inspections and Compliance

The regulatory environment, particularly FDA inspections of foreign manufacturing facilities, can impact the production and distribution of CAPOZIDE. Compliance with FDA regulations is crucial to ensure the quality and safety of the drug, which in turn affects its market availability and financial performance[3].

Policy Changes and Reforms

Impact on Pricing and Access

Policy changes, especially those related to Medicare programs, can significantly impact the pricing and access to CAPOZIDE. For instance, reforms that extend to the commercial market could lead to a decline in out-of-pocket costs and a reduction in net spending, which might affect the revenue trajectory of CAPOZIDE[4].

Key Takeaways

  • Market Stability: The generic drug market, including CAPOZIDE, is expected to see modest revenue growth despite mid-single-digit percent annual price erosion.
  • Clinical Efficacy: CAPOZIDE has been shown to be effective and well-tolerated in various patient populations, contributing to high patient compliance.
  • Regulatory Compliance: Adherence to FDA regulations is critical for maintaining market availability and ensuring the quality and safety of CAPOZIDE.
  • Pricing Strategies: Manufacturers must balance revenue goals with patient affordability through various pricing strategies.
  • Policy Impact: Policy changes, especially those affecting Medicare programs, can influence the pricing and access to CAPOZIDE.

FAQs

Q: What is CAPOZIDE 25/15 used for?

A: CAPOZIDE 25/15 is used for the treatment of hypertension. It combines an ACE inhibitor (captopril) and a thiazide diuretic (hydrochlorothiazide) to lower blood pressure.

Q: How does CAPOZIDE 25/15 compare to other antihypertensive medications?

A: CAPOZIDE 25/15 is effective and well-tolerated, with a favorable side effect profile. Its combination of captopril and hydrochlorothiazide makes it a popular choice for managing hypertension.

Q: What are the potential risks associated with CAPOZIDE 25/15?

A: Potential risks include neutropenia/agranulocytosis and other side effects associated with ACE inhibitors and thiazide diuretics. Regular monitoring is recommended to mitigate these risks[1].

Q: How does the regulatory environment impact CAPOZIDE 25/15?

A: FDA inspections and compliance with regulations are crucial for ensuring the quality and safety of CAPOZIDE. Non-compliance can lead to market disruptions and financial losses[3].

Q: What is the outlook for the financial performance of CAPOZIDE 25/15?

A: The financial performance of CAPOZIDE 25/15 is expected to be stable with modest revenue growth, driven by increasing demand for antihypertensive medications and the overall growth in the generic drug market[4].

Sources

  1. RxList: Capozide (Captopril and Hydrochlorothiazide): Side Effects, Uses ...
  2. CMS: Physician Group Practice Demonstration Quality Measurement and ...
  3. S&P Global: Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue ...
  4. IQVIA: Medicine Use and Spending in the U.S. - IQVIA
  5. PubMed: Treating black hypertensives with capozide - PubMed

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