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Last Updated: December 28, 2024

Oxprenolol hydrochloride - Generic Drug Details


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What are the generic sources for oxprenolol hydrochloride and what is the scope of patent protection?

Oxprenolol hydrochloride is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for oxprenolol hydrochloride
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 79
Patent Applications: 942
DailyMed Link:oxprenolol hydrochloride at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for oxprenolol hydrochloride

US Patents and Regulatory Information for oxprenolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-002 Dec 28, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-004 Dec 28, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-001 Dec 28, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for oxprenolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-002 Dec 28, 1983 ⤷  Subscribe ⤷  Subscribe
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-003 Dec 28, 1983 ⤷  Subscribe ⤷  Subscribe
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-004 Dec 28, 1983 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Oxprenolol hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxprenolol Hydrochloride

Introduction

Oxprenolol hydrochloride, a non-selective beta-adrenergic receptor antagonist, is used primarily in the treatment of hypertension, angina pectoris, and other cardiovascular conditions. Understanding its market dynamics and financial trajectory involves analyzing various factors, including its pharmacological profile, clinical efficacy, competition, and regulatory environment.

Pharmacological Profile and Clinical Efficacy

Oxprenolol hydrochloride is distinguished by its intrinsic sympathomimetic activity (ISA) and membrane stabilizing effects, which set it apart from other beta blockers like propranolol. It undergoes significant first-pass metabolism, with only 30% of an oral dose reaching systemic circulation, and is approximately 80% protein bound[1].

Therapeutic Uses

Oxprenolol is effective in reducing heart rate and prolonging the atrioventricular nodal refractory period, making it comparable to other beta blockers in treating hypertension and angina pectoris. Its partial agonist effect may offer advantages in patients with borderline cardiac reserve[1].

Market Competition

The antihypertensive drug market is highly competitive, with numerous drugs available for similar indications. Oxprenolol competes with other beta blockers such as propranolol, atenolol, and metoprolol, as well as other classes of antihypertensive drugs like ACE inhibitors, calcium channel blockers, and diuretics.

Generic Competition

The generic drug industry plays a significant role in shaping the market dynamics of oxprenolol. Generic versions of oxprenolol can enter the market once the patent expires, leading to increased competition and reduced prices. Studies have shown that generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are eight or more competitors[3].

Regulatory Environment

Regulatory policies significantly impact the market trajectory of oxprenolol. For instance, changes in FDA policies, such as increased scrutiny of generic drug applications or simultaneous approval of multiple generic entrants, can affect the timing and cost of market entry. These policies can lower prices in the short term but may reduce the number of firms applying for FDA approval in the long term[3].

Financial Trajectory

Revenue and Profitability

The financial performance of oxprenolol is influenced by its market share, pricing, and competition. Initially, as a branded drug, oxprenolol generates significant revenue and profits. However, with the entry of generic versions, revenue and profitability decline as prices drop and market share is eroded.

Cost Structure

The cost structure of oxprenolol includes research and development expenses, manufacturing costs, marketing expenditures, and regulatory compliance costs. The high cost of obtaining FDA approval for generic versions can also impact the financial trajectory, as it may deter some potential entrants[3].

Market Size and Growth

The market size for antihypertensive drugs is substantial and growing due to increasing prevalence of hypertension and other cardiovascular diseases. However, the growth of oxprenolol's market share is constrained by the availability of alternative treatments and the competitive landscape.

Geographic Variations

Market dynamics can vary geographically due to differences in healthcare systems, regulatory environments, and patient preferences. In some regions, oxprenolol may maintain a stronger market presence due to local preferences or limited availability of alternative treatments.

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics of oxprenolol. The drug's unique pharmacological profile, particularly its ISA and membrane stabilizing effects, may make it a preferred choice for certain patients. However, prescribers may also consider other factors such as side effect profiles, dosing convenience, and cost when making treatment decisions.

Future Outlook

The future outlook for oxprenolol hydrochloride is influenced by several factors:

Emerging Therapies

The development of new antihypertensive therapies could pose a challenge to oxprenolol's market position. Emerging drugs with improved efficacy, safety, or convenience may attract prescribers and patients away from traditional beta blockers.

Generic Market Saturation

As more generic versions of oxprenolol enter the market, the price competition is expected to intensify, leading to further erosion of revenue and profitability for the branded version.

Regulatory Changes

Changes in regulatory policies or guidelines could impact the market dynamics. For example, stricter safety standards or new labeling requirements could affect the drug's market position.

Key Takeaways

  • Pharmacological Profile: Oxprenolol hydrochloride has unique properties including ISA and membrane stabilizing effects.
  • Market Competition: The drug faces competition from other beta blockers and antihypertensive classes.
  • Generic Competition: Generic versions significantly impact pricing and market share.
  • Regulatory Environment: FDA policies influence market entry and competition.
  • Financial Trajectory: Revenue and profitability decline with generic competition.
  • Market Size and Growth: The antihypertensive market is growing, but oxprenolol's share is constrained by competition.

FAQs

What is oxprenolol hydrochloride used for?

Oxprenolol hydrochloride is used primarily for the treatment of hypertension, angina pectoris, and other cardiovascular conditions[4].

How does oxprenolol hydrochloride differ from other beta blockers?

Oxprenolol has intrinsic sympathomimetic activity (ISA) and membrane stabilizing effects, which distinguish it from other beta blockers like propranolol[1].

What is the impact of generic competition on oxprenolol hydrochloride?

Generic competition leads to reduced prices and market share erosion for the branded version of oxprenolol, as generic drug prices decline with the number of competitors[3].

How do regulatory changes affect the market dynamics of oxprenolol hydrochloride?

Regulatory changes, such as increased FDA scrutiny or simultaneous approval of multiple generics, can affect the timing and cost of market entry, influencing the financial trajectory of oxprenolol[3].

What is the future outlook for oxprenolol hydrochloride?

The future outlook is influenced by emerging therapies, generic market saturation, and potential regulatory changes, all of which could impact its market position and financial performance.

Sources

  1. PubMed: Oxprenolol undergoes first pass metabolism with only 30% of an oral dose reaching the systemic circulation.
  2. American Heart Association: Oral Antihypertensives for Nonsevere Pregnancy Hypertension.
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. Patsnap Synapse: What is Oxprenolol Hydrochloride used for?
  5. Frontiers in Physiology: How Do Antihypertensive Drugs Work? Insights from Studies of the Kidney.

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