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Last Updated: December 22, 2024

COSMEGEN Drug Patent Profile


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When do Cosmegen patents expire, and what generic alternatives are available?

Cosmegen is a drug marketed by Recordati Rare and is included in one NDA.

The generic ingredient in COSMEGEN is dactinomycin. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cosmegen

A generic version of COSMEGEN was approved as dactinomycin by EUGIA PHARMA on November 9th, 2017.

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Summary for COSMEGEN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 16
Patent Applications: 3,281
Drug Prices: Drug price information for COSMEGEN
What excipients (inactive ingredients) are in COSMEGEN?COSMEGEN excipients list
DailyMed Link:COSMEGEN at DailyMed
Drug patent expirations by year for COSMEGEN
Drug Prices for COSMEGEN

See drug prices for COSMEGEN

Recent Clinical Trials for COSMEGEN

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

SponsorPhase
H. Lee Moffitt Cancer Center and Research InstitutePhase 2
National Pediatric Cancer FoundationPhase 2
Tufts Medical CenterPhase 3

See all COSMEGEN clinical trials

US Patents and Regulatory Information for COSMEGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare COSMEGEN dactinomycin INJECTABLE;INJECTION 050682-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

COSMEGEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dactinomycin (COSMEGEN)

Introduction

Dactinomycin, marketed under the brand name Cosmegen, is a potent chemotherapeutic agent primarily used in the treatment of various cancers, including Wilms’ tumor, rhabdomyosarcoma, and certain testicular cancers. Here, we delve into the market dynamics and financial trajectory of Dactinomycin, highlighting key factors influencing its market growth and challenges.

Market Size and Forecast

The Dactinomycin market has been experiencing steady growth. As of 2023, the market size was valued at USD 6.9 billion and is projected to reach USD 7.81 billion by 2031, growing at a compound annual growth rate (CAGR) of 8.27% during the forecast period 2024-2030[1][3].

Key Drivers of Market Growth

Rising Incidence of Cancers

The increasing global incidence of cancers, particularly those treated with Dactinomycin such as Wilms’ tumor and rhabdomyosarcoma, is a significant driver of market growth. As the global population ages and cancer diagnoses rise, the demand for effective cancer treatments like Dactinomycin is expected to increase[1].

Advancements in Cancer Treatment Protocols

Ongoing research and clinical trials are likely to expand the therapeutic applications of Dactinomycin. New combinations and protocols involving Dactinomycin could enhance its usage in oncology treatment, contributing to market growth[1].

Aging Population

The growing and aging population is associated with an increase in cancer diagnoses, which in turn boosts the demand for Dactinomycin as part of treatment regimens[1].

Increased R&D Investment

Pharmaceutical companies are investing heavily in research and development for innovative cancer therapies, including those involving Dactinomycin. This investment is expected to expand its therapeutic applications and drive market growth[1].

Availability of Generic Versions

The entry of generic versions of Dactinomycin makes the drug more accessible and affordable, leading to increased use in various healthcare settings. This increased accessibility is a significant factor in market expansion[1].

Healthcare Infrastructure Improvement

Enhanced healthcare infrastructure in developing regions facilitates better access to cancer treatments, including Dactinomycin, thus driving demand. Improvements in healthcare access and infrastructure are crucial for the growth of the Dactinomycin market[1].

Supportive Government Policies

Governments are increasingly supporting cancer research and treatment initiatives, which includes improving access to existing cancer therapies like Dactinomycin. These supportive policies are instrumental in driving market growth[1].

Regional Market Dynamics

North America

North America is a prominent market for Dactinomycin, characterized by advanced healthcare infrastructure, extensive research and development activities, and a growing prevalence of cancer. These factors drive the demand for effective therapeutic options like Dactinomycin[1].

Europe

Europe also displays significant market potential, with robust regulatory frameworks and increased healthcare spending facilitating access to innovative treatments. The region's strong healthcare system and research environment contribute to the growth of the Dactinomycin market[1].

Asia-Pacific

The Asia-Pacific region is witnessing rapid expansion in the Dactinomycin market, fueled by a large patient population, improving healthcare facilities, and enhancing awareness about cancer treatments. Countries like India and China are emerging as key players due to their growing pharmaceutical sectors and increasing investments in oncology research[1].

Middle East and Africa

While relatively smaller markets, the Middle East and Africa show promise as modern healthcare systems continue to evolve. However, these regions face unique challenges, including varying healthcare accessibility and affordability, which dictate the pace of market growth[1].

Challenges and Constraints

Regulatory Challenges

The approval process for new drugs or generics can be lengthy and complicated. Any changes in regulations or increased scrutiny from health authorities can delay market entry and affect supply, posing a significant challenge to the Dactinomycin market[1].

High Development Costs

The costs associated with research, development, and clinical trials are substantial. Companies may be hesitant to invest heavily in Dactinomycin, impacting availability and competition in the market[1].

Competition from Other Therapies

The cancer treatment market is highly competitive, with newer therapies and treatment modalities offering better efficacy, fewer side effects, or more convenient administration routes. This competition can reduce the demand for Dactinomycin[1].

Side Effects and Toxicity

Dactinomycin has notable side effects, which can limit its use in certain patient populations. Increased awareness and preference for treatments with fewer adverse effects can impact its market growth[1].

Pricing Pressure

Healthcare cost containment measures, including price negotiations and insurance coverage limitations, can affect the profitability of Dactinomycin, especially in markets with strict pricing regulations[1].

Financial Trajectory

The financial trajectory of Dactinomycin is closely tied to its market growth drivers and challenges. Here are some key financial aspects:

Revenue Growth

The market is expected to grow significantly, with the global Dactinomycin market size projected to reach USD 7.81 billion by 2031. This growth is driven by increasing demand due to rising cancer incidence, advancements in treatment protocols, and improved healthcare infrastructure[1].

Cost and Pricing

The availability of generic versions and the impact of pricing regulations can affect the profitability of Dactinomycin. Despite these challenges, the market is expected to see steady growth due to its critical role in cancer treatment[1].

Regional Financial Performance

North America and Europe are expected to remain significant contributors to the financial performance of the Dactinomycin market, while the Asia-Pacific region is anticipated to show rapid growth due to its large patient population and improving healthcare infrastructure[1].

Key Players

Major players in the Dactinomycin market include Pfizer Inc., Teva Pharmaceutical Industries Ltd., Fresenius Kabi AG, Mylan N.V., Hikma Pharmaceuticals PLC, and others. These companies are investing in research and development and expanding their distribution networks to capitalize on the growing demand for Dactinomycin[1].

Conclusion

The Dactinomycin market is poised for significant growth driven by increasing cancer incidence, advancements in treatment protocols, and improvements in healthcare infrastructure. However, the market also faces challenges such as regulatory hurdles, high development costs, and competition from other therapies.

Key Takeaways

  • Market Growth: The Dactinomycin market is projected to reach USD 7.81 billion by 2031, growing at a CAGR of 8.27% from 2024 to 2030.
  • Key Drivers: Rising cancer incidence, advancements in treatment protocols, aging population, increased R&D investment, and improved healthcare infrastructure.
  • Regional Dynamics: North America, Europe, and Asia-Pacific are key regions driving market growth.
  • Challenges: Regulatory challenges, high development costs, competition from other therapies, side effects, and pricing pressure.
  • Financial Trajectory: Steady revenue growth driven by increasing demand and critical role in cancer treatment.

FAQs

What is the primary use of Dactinomycin?

Dactinomycin is primarily used in the treatment of various cancers, including Wilms’ tumor, rhabdomyosarcoma, and certain testicular cancers.

What is the projected market size of Dactinomycin by 2031?

The Dactinomycin market is projected to reach USD 7.81 billion by 2031, growing at a CAGR of 8.27% from 2024 to 2030[1].

Which regions are driving the growth of the Dactinomycin market?

North America, Europe, and the Asia-Pacific region are key drivers of the Dactinomycin market growth due to their advanced healthcare infrastructure, extensive research activities, and large patient populations[1].

What are the major challenges facing the Dactinomycin market?

The market faces challenges such as regulatory hurdles, high development costs, competition from other therapies, side effects, and pricing pressure[1].

Who are the major players in the Dactinomycin market?

Major players include Pfizer Inc., Teva Pharmaceutical Industries Ltd., Fresenius Kabi AG, Mylan N.V., Hikma Pharmaceuticals PLC, and others[1].

Sources

  1. Verified Market Research - Dactinomycin Market Size, Share, Scope, Trends And Forecast
  2. Stock Titan - Cosmos Health Releases 2024-2027 Updated Guidance
  3. GII Research - Dactinomycin Global Market Report 2024
  4. Business Wire - Global Nephroblastoma Treatment Market Report 2022: Increasing R&D Activities Driving Sector Growth - ResearchAndMarkets.com
  5. Stock Titan - Cosmos Health Projects 25% Revenue Growth to $68.4M by 2025

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