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Last Updated: December 22, 2024

DYNAPEN Drug Patent Profile


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Which patents cover Dynapen, and what generic alternatives are available?

Dynapen is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in DYNAPEN is dicloxacillin sodium. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dynapen

A generic version of DYNAPEN was approved as dicloxacillin sodium by TEVA on June 3rd, 1982.

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Summary for DYNAPEN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 36
Patent Applications: 5,084
DailyMed Link:DYNAPEN at DailyMed
Drug patent expirations by year for DYNAPEN

US Patents and Regulatory Information for DYNAPEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon DYNAPEN dicloxacillin sodium FOR SUSPENSION;ORAL 050337-002 Approved Prior to Jan 1, 1982 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

DYNAPEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dicloxacillin (DYNAPEN)

Overview of Dicloxacillin (DYNAPEN)

Dicloxacillin, marketed under various brand names including DYNAPEN, is a beta-lactamase resistant penicillin used to treat infections caused by penicillinase-producing staphylococci. Here, we will delve into the market dynamics and financial aspects of this antibiotic.

Market Size and Growth

The global penicillin market, which includes dicloxacillin, is expected to grow significantly over the coming years. By 2024, the penicillin drug market is predicted to reach a size of over USD 9.6 billion and is expected to grow to more than USD 13.4 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 3.8% during this period[3].

Segment Analysis

  • Natural vs. Semisynthetic Penicillins: Natural penicillins are expected to dominate the market due to their historical prominence, safety, and compliance with regulations. However, semisynthetic penicillins like dicloxacillin remain crucial for treating infections caused by penicillinase-producing bacteria[3].

  • Route of Administration: Oral administration is the preferred route for penicillins, including dicloxacillin, due to convenience, patient preference, and cost-effectiveness[3].

  • Spectrum of Activity: Broad-spectrum penicillins, which include dicloxacillin, are favored for their efficacy against diverse bacterial infections, simplifying treatment and reducing healthcare costs[3].

Market Drivers

Increasing Demand for Antibiotics

The growing need for effective antibiotics to combat bacterial infections drives the demand for penicillins like dicloxacillin. The integration of digital health technologies, such as telemedicine platforms, also improves patient care and medication adherence, contributing to market growth[3].

Customized Medicinal Drugs

The trend towards customized medicinal drugs, tailored to individual patients based on genetic makeup and other factors, is expected to improve the effectiveness of penicillin formulations and dosing regimens. This personalized approach can enhance the market for dicloxacillin and other penicillins[3].

Continuous Manufacturing Processes

The adoption of continuous manufacturing processes in the pharmaceutical industry offers advantages such as advanced performance, reduced production costs, and better quality control. This can positively impact the production and availability of dicloxacillin[3].

Market Challenges

Regulatory Requirements

Stringent regulatory requirements for the approval of new drugs, including penicillin formulations, can result in delays and increased costs. This poses a barrier to market access for pharmaceutical companies producing dicloxacillin[3].

Antibiotic Resistance and Overuse

Increasing awareness of the risks associated with antibiotic overuse, such as the development of antibiotic-resistant bacteria and adverse drug reactions, may lead to stricter prescribing guidelines and reduced demand for penicillins like dicloxacillin[3].

Raw Material Dependence and Supply Chain Disruptions

The dependence on specific raw materials for penicillin production, coupled with potential delivery chain disruptions and shortages, can constrain market growth and impact the availability of dicloxacillin[3].

Financial Trajectory

Pricing and Cost

Dicloxacillin capsules are priced competitively, with costs ranging from approximately $0.66 to $1.25 per capsule, depending on the dosage and formulation[1].

Market Share and Revenue

While specific financial data for dicloxacillin (DYNAPEN) is not readily available, the overall penicillin market is expected to grow significantly. North America is projected to dominate with a 38.2% market share due to its well-established healthcare and robust pharmaceutical industry[3].

Competitive Landscape

The penicillin market, including dicloxacillin, is competitive with various brands and generic options available. Pharmaceutical companies are diversifying their product portfolios through acquisitions and innovations to capture new growth opportunities[3].

Key Takeaways

  • Market Growth: The global penicillin market, including dicloxacillin, is expected to grow to USD 13.4 billion by 2033 with a CAGR of 3.8%.
  • Market Drivers: Increasing demand for antibiotics, customized medicinal drugs, and continuous manufacturing processes drive the market.
  • Challenges: Regulatory requirements, antibiotic resistance, and raw material dependence pose significant challenges.
  • Financial Trajectory: Competitive pricing and a strong market presence in regions like North America contribute to the financial stability of dicloxacillin.

FAQs

What is dicloxacillin used for?

Dicloxacillin is used to treat infections caused by penicillinase-producing staphylococci, which are bacteria that produce an enzyme that makes them resistant to many other penicillins[1].

How does dicloxacillin work?

Dicloxacillin works by inhibiting bacterial cell wall biosynthesis, making the bacterial cell wall weak and leading to the death of the bacteria[1].

What are the common brand names for dicloxacillin?

Dicloxacillin is marketed under various brand names including DYNAPEN, Amcidil, Betaclox, Cloxagen, and others[1].

What are the potential side effects of dicloxacillin?

Common side effects include gastrointestinal issues, allergic reactions, and in rare cases, more severe reactions such as anaphylaxis[1].

How is dicloxacillin administered?

Dicloxacillin is typically administered orally in capsule form, with dosages varying based on the type and severity of the infection[1].

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