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Last Updated: December 22, 2024

DOPRAM Drug Patent Profile


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When do Dopram patents expire, and when can generic versions of Dopram launch?

Dopram is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in DOPRAM is doxapram hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the doxapram hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dopram

A generic version of DOPRAM was approved as doxapram hydrochloride by CHARTWELL INJECTABLE on January 10th, 2003.

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Summary for DOPRAM
Drug patent expirations by year for DOPRAM
Drug Prices for DOPRAM

See drug prices for DOPRAM

Recent Clinical Trials for DOPRAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nederlands Neonataal Netwerk (N3), the NetherlandsPhase 3
Erasmus Medical CenterPhase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 3

See all DOPRAM clinical trials

Pharmacology for DOPRAM

US Patents and Regulatory Information for DOPRAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma DOPRAM doxapram hydrochloride INJECTABLE;INJECTION 014879-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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

DOPRAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doxapram (Dopram)

Introduction to Doxapram (Dopram)

Doxapram, commonly known by its brand name Dopram, is a short-acting respiratory stimulant used primarily to treat acute respiratory insufficiency in patients with chronic obstructive pulmonary disease (COPD) and other conditions such as postoperative respiratory depression and drug-induced respiratory depression[4].

Market Size and Growth

The market for respiratory stimulants, including doxapram, is influenced by several factors. While specific market size data for doxapram alone is not readily available, the broader respiratory drug market provides context. The global respiratory drugs market is growing due to increasing incidences of respiratory diseases, technological advancements, and a rising preference for non-invasive treatment methods.

For instance, the global market for topical drug delivery, which includes some respiratory treatments, is projected to grow at a CAGR of 6.3% from 2024 to 2031, reaching USD 177.97 billion by 2031[3].

Key Market Drivers

Increasing Incidence of Respiratory Diseases

The rising prevalence of COPD, asthma, and other respiratory conditions drives the demand for respiratory stimulants like doxapram. As the global population ages and urbanization increases, the incidence of these diseases is expected to rise, thereby boosting the market[3].

Technological Advancements

Advancements in drug formulations and delivery systems enhance the efficacy and safety of respiratory stimulants. Innovations in intravenous formulations, for example, can improve the administration and effectiveness of doxapram[4].

Preference for Non-Invasive Treatments

There is a growing preference for non-invasive and less intrusive treatment methods, which can include the use of respiratory stimulants as an alternative to more invasive procedures. This trend supports the market growth for drugs like doxapram[3].

Market Restraints

Regulatory Challenges

The development and approval of new respiratory drugs, including doxapram formulations, are subject to stringent regulatory requirements. These regulations can slow down market entry and impact the financial trajectory of the drug[1].

Competition from Alternative Treatments

The respiratory drug market is highly competitive, with various treatment options available. Alternative treatments, such as inhalers and other respiratory medications, can compete with doxapram for market share[3].

Financial Flows and Reimbursement

Product Movement and Financial Flows

In the U.S. pharmacy distribution system, the financial flows for doxapram involve several key players. Manufacturers sell the drug to wholesalers, who then supply it to pharmacies. Pharmacies are reimbursed by Pharmacy Benefit Managers (PBMs) and third-party payers. Manufacturers also provide rebates to PBMs, which can reduce the net prescription costs[2].

Pricing and Cost Considerations

The pricing of doxapram can vary based on the region and the specific formulation. For example, the cost of doxapram hydrochloride injection can range from $2.52 to $4.67 per mL, depending on the supplier and the market[4].

Competitive Landscape

Key Players

The market for respiratory stimulants includes several key players, although doxapram is not as widely marketed as some other respiratory drugs. Companies like Hikma Pharmaceuticals, Baxter Laboratories, and Bedford Pharmaceuticals are involved in the production and distribution of doxapram[4].

Strategic Collaborations

Strategic collaborations and partnerships are crucial in the pharmaceutical industry. These collaborations can help in the development of new formulations, improve distribution channels, and enhance market penetration for drugs like doxapram.

Regional Analysis

Global Market Distribution

The global market for respiratory drugs is distributed across various regions, with North America, Europe, and the Asia-Pacific region being significant markets. The demand for doxapram is likely to be higher in regions with a high incidence of respiratory diseases[1].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, offer significant growth opportunities due to increasing healthcare spending and a growing awareness of respiratory diseases. These markets are expected to drive the future growth of the respiratory stimulant market[3].

Regulatory Landscape

Approval and Compliance

Doxapram has been approved for use in various countries, including the United States, where it is used as a temporary measure in hospitalized patients with acute respiratory insufficiency superimposed on COPD. Regulatory compliance is critical for maintaining market presence and ensuring the safety and efficacy of the drug[4].

Future Regulatory Trends

Future regulatory trends, including stricter safety standards and more stringent approval processes, can impact the market dynamics for doxapram. Manufacturers must stay abreast of these changes to ensure continued market access.

Technological Trends

Innovations in Drug Formulations

Technological advancements in drug formulations are expected to play a significant role in the future of respiratory stimulants. Innovations such as improved intravenous formulations and more efficient delivery systems can enhance the efficacy and safety of doxapram[3].

Digital Health Integration

The integration of digital health technologies, such as monitoring devices and telehealth services, can improve patient outcomes and enhance the use of respiratory stimulants like doxapram.

SWOT Analysis

Strengths

  • Established Use: Doxapram has an established use in treating acute respiratory insufficiency.
  • Quick Action: It acts rapidly, making it a valuable option in emergency situations.
  • Wide Distribution: Available through various pharmaceutical companies and distribution channels.

Weaknesses

  • Short Duration of Action: Doxapram has a brief duration of action, requiring frequent administration.
  • Side Effects: It can cause side effects such as hypertension and increased heart rate.
  • Competition: Faces competition from other respiratory treatments.

Opportunities

  • Growing Demand: Increasing incidence of respiratory diseases offers growth opportunities.
  • Technological Advancements: Innovations in drug formulations and delivery systems.
  • Emerging Markets: Potential for growth in emerging markets.

Threats

  • Regulatory Changes: Stricter regulatory requirements can impact market access.
  • Competition from Alternatives: Other respiratory treatments and medications.
  • Economic Factors: Economic downturns can affect healthcare spending and drug sales.

Future Outlook

Market Projections

While specific market projections for doxapram are not available, the broader respiratory drug market is expected to grow significantly. The global topical drug delivery market, for instance, is projected to reach USD 177.97 billion by 2031, indicating a positive trend for respiratory treatments[3].

Challenges and Opportunities

The future of doxapram will be shaped by its ability to adapt to regulatory changes, technological advancements, and market competition. Opportunities in emerging markets and the growing demand for non-invasive treatments are expected to drive growth.

Key Takeaways

  • Established Market Presence: Doxapram has an established use in treating acute respiratory insufficiency.
  • Growing Demand: Increasing incidence of respiratory diseases drives market growth.
  • Technological Advancements: Innovations in drug formulations and delivery systems are crucial.
  • Regulatory Compliance: Adherence to regulatory standards is essential for market access.
  • Emerging Markets: Significant growth opportunities exist in emerging markets.

FAQs

What is Doxapram Used For?

Doxapram is used to treat acute respiratory insufficiency in patients with chronic obstructive pulmonary disease (COPD) and other conditions such as postoperative respiratory depression and drug-induced respiratory depression[4].

How Does Doxapram Work?

Doxapram works by stimulating the central nervous system and increasing respiratory rate and tidal volume. It acts through the peripheral carotid chemoreceptors[4].

What Are the Side Effects of Doxapram?

Common side effects include hypertension, increased heart rate, and other cardiovascular effects. It can also cause nausea, vomiting, and other gastrointestinal symptoms[4].

Who Are the Key Players in the Doxapram Market?

Key players include Hikma Pharmaceuticals, Baxter Laboratories, and Bedford Pharmaceuticals, among others[4].

What Are the Future Growth Prospects for Doxapram?

The future growth of doxapram is expected to be driven by increasing demand for respiratory treatments, technological advancements, and opportunities in emerging markets[3].

Sources

  1. Cognitivemarketresearch.com: Doxapram Hydrochloride Market Report 2024 (Global Edition)[1].
  2. Drugchannels.net: Follow the Dollar: The U.S. Pharmacy Distribution and Reimbursement System[2].
  3. Globenewswire.com: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031 Globally at 6.3% CAGR[3].
  4. DrugBank Online: Doxapram: Uses, Interactions, Mechanism of Action[4].

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