Dactinomycin - Generic Drug Details

What are the generic drug sources for dactinomycin and what is the scope of freedom to operate?

Dactinomycin is the generic ingredient in two branded drugs marketed by Recordati Rare, Am Regent, Eugia Pharma, Hikma, Hisun Pharm Hangzhou, Meitheal, and Xgen Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for dactinomycin. Four suppliers are listed for this compound.

Summary for dactinomycin

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	47
Patent Applications:	2,651
Drug Prices:	Drug price trends for dactinomycin
What excipients (inactive ingredients) are in dactinomycin?	dactinomycin excipients list
DailyMed Link:	dactinomycin at DailyMed

See drug prices for dactinomycin

Recent Clinical Trials for dactinomycin

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 1/Phase 2
xiang yang	N/A
University of Birmingham	Phase 1/Phase 2

See all dactinomycin clinical trials

Pharmacology for dactinomycin

Drug Class	Actinomycin
Mechanism of Action	Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for dactinomycin

Anti-Bacterial Agents

Antibiotics, Antineoplastic

Nucleic Acid Synthesis Inhibitors

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dactinomycin

L01DA	Actinomycines
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for dactinomycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	090304-001	Mar 16, 2010		DISCN	No	No
Hisun Pharm Hangzhou	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	207232-001	Jul 16, 2019	AP	RX	No	No
Recordati Rare	COSMEGEN	dactinomycin	INJECTABLE;INJECTION	050682-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Xgen Pharms	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203999-001	May 20, 2019	AP	RX	No	No
Eugia Pharma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385-001	Nov 9, 2017	AP	RX	No	Yes
Meitheal	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	213463-001	Nov 13, 2020	AP	RX	No	No
Am Regent	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	202562-001	Aug 23, 2013		DISCN	No	No

Dactinomycin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dactinomycin

Introduction to Dactinomycin

Dactinomycin, also known by its brand name Cosmegen, is a chemotherapeutic agent used primarily in the treatment of various types of cancer, including Wilms’ tumor, rhabdomyosarcoma, Ewing sarcoma, and certain testicular cancers. Here, we will delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Forecast

The global Dactinomycin market is projected to experience significant growth over the coming years. As of 2023, the market size was valued at USD 6.9 billion and is expected to reach USD 7.81 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.27% from 2024 to 2031[4].

Key Drivers of Market Growth

Rising Incidence of Cancers

The increasing global incidence of cancers, particularly those that Dactinomycin is used to treat, is a major driver of market growth. This trend is expected to continue, driven by an aging population and other demographic factors[4].

Advancements in Cancer Treatment Protocols

Ongoing research and clinical trials are likely to expand the therapeutic applications of Dactinomycin, making it a more integral part of oncology treatment protocols. New combinations and applications of the drug could further boost its usage[4].

Aging Population

The growing and aging population is associated with an increased incidence of cancer, which in turn drives the demand for effective cancer treatments like Dactinomycin[4].

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 lead to new and improved treatment options[4].

Availability of Generic Versions

The entry of generic versions of Dactinomycin into the market can make the drug more accessible and affordable, leading to increased use in various healthcare settings[4].

Geographical Market Dynamics

North America

North America is a prominent market for Dactinomycin, characterized by advanced healthcare infrastructure, extensive research and development activities, and a high prevalence of cancer. These factors drive the demand for effective therapeutic options like Dactinomycin[4].

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 infrastructure supports the adoption of Dactinomycin[4].

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[4].

Middle East and Africa

While smaller, the Middle East and Africa markets 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[4].

Competitive Landscape

The Dactinomycin market is characterized by a mix of established and emerging players. Key companies in this market include Pfizer Inc., Teva Pharmaceutical Industries Ltd., Fresenius Kabi AG, Mylan N.V., and Hikma Pharmaceuticals PLC, among others. These companies are involved in various market-related activities such as new product releases, collaborations, mergers and acquisitions, and significant developments in the field of oncology[4].

Challenges and Restraints

Regulatory Challenges

The approval process for new drugs or generics can be lengthy and complicated. Changes in regulations or increased scrutiny from health authorities can delay market entry and affect supply, posing a challenge to the growth of the Dactinomycin market[4].

High Development Costs

The costs associated with research, development, and clinical trials are substantial. This can deter companies from investing heavily in Dactinomycin, impacting its availability and competition in the market[4].

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 potentially reduce the demand for Dactinomycin[4].

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[4].

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[4].

Financial Trajectory

The financial trajectory of the Dactinomycin market is positive, with a projected CAGR of 8.27% from 2024 to 2031. Here are some key financial indicators:

• Market Size in 2023: USD 6.9 billion[4].
• Projected Market Size in 2031: USD 7.81 billion[4].
• CAGR: 8.27% from 2024 to 2031[4].

Segmentation and Revenue Streams

The Dactinomycin market is segmented based on application, product type, and geography.

• Application: Alkylating agent, hormone, plant medicine[1].
• Product Type: Injection, implants[1].
• Geography: North America, Europe, Asia-Pacific, Middle East and Africa, and South America[1].

Each segment contributes to the overall revenue, with the oncology segment being the most significant due to the drug's primary use in cancer treatment.

Key Takeaways

• The Dactinomycin market is expected to grow significantly, driven by the rising incidence of cancers and advancements in cancer treatment protocols.
• The market is segmented by application, product type, and geography, with North America and Europe being key regions.
• The competitive landscape includes major pharmaceutical companies, and the market faces challenges such as regulatory hurdles, high development costs, and competition from other therapies.
• The financial trajectory is positive, with a projected CAGR of 8.27% from 2024 to 2031.

FAQs

What is Dactinomycin used for?

Dactinomycin is used to treat certain types of cancer, including Wilms’ tumor, rhabdomyosarcoma, Ewing sarcoma, and certain testicular cancers[2].

What are the side effects of Dactinomycin?

Common side effects include hair loss, nausea, vomiting, and more serious effects such as bone marrow problems, increased risk of other cancers, and severe tissue damage if the drug leaks from the vein during injection[2].

What is the projected market size of Dactinomycin by 2031?

The Dactinomycin market is projected to reach USD 7.81 billion by 2031[4].

Which regions are the most significant for the Dactinomycin market?

North America and Europe are the most significant regions, followed by the Asia-Pacific region, which is experiencing rapid growth[4].

What are the key challenges facing the Dactinomycin market?

Key challenges include regulatory hurdles, high development costs, competition from other therapies, side effects and toxicity, and pricing pressure[4].

Cited Sources:

1. Market Research Intellect, "Global Dactinomycin Market Size and Forecast", October 2024.
2. Mayo Clinic, "Dactinomycin (intravenous route)", February 01, 2024.
3. Research and Markets, "Dactinomycin Global Market Size, Competitors & Forecast".
4. Verified Market Research, "Dactinomycin Market Size, Share, Scope, Trends And Forecast".