CORTICOTROPIN - Generic Drug Details

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

Corticotropin is the generic ingredient in seven branded drugs marketed by Parkedale, Sanofi Aventis Us, Mallinckrodt Ard, Organics Lagrange, Watson Labs, and Ani Pharms, and is included in seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for corticotropin. Two suppliers are listed for this compound.

Summary for CORTICOTROPIN

US Patents:	3
Tradenames:	7
Applicants:	6
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	57
Patent Applications:	6,827
DailyMed Link:	CORTICOTROPIN at DailyMed

Recent Clinical Trials for CORTICOTROPIN

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

Sponsor	Phase
Yangzhou University	N/A
Rutgers, The State University of New Jersey	Phase 2
Feinstein Institute for Medical Research	Phase 2

See all CORTICOTROPIN clinical trials

Pharmacology for CORTICOTROPIN

Drug Class

Adrenocorticotropic Hormone

Anatomical Therapeutic Chemical (ATC) Classes for CORTICOTROPIN

H01AA	ACTH
H01A	ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for CORTICOTROPIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organics Lagrange	CORTICOTROPIN	corticotropin	INJECTABLE;INJECTION	010831-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-001	Approved Prior to Jan 1, 1982		DISCN	No	No	12,102,662
Mallinckrodt Ard	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Parkedale	ACTH	corticotropin	INJECTABLE;INJECTION	008317-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	CORTICOTROPIN	corticotropin	INJECTABLE;INJECTION	088772-001	Nov 21, 1984		DISCN	No	No

CORTICOTROPIN Market Analysis and Financial Projection Experimental

Corticotropic Hormone (ACTH) Market Dynamics and Financial Trajectory

Market Overview

The global Adrenocorticotropic Hormone (ACTH) market, also known as the corticotropic hormone market, is experiencing significant growth driven by various factors. Here is a comprehensive look at the market dynamics and financial trajectory of this sector.

Market Size and Growth Rate

As of 2021, the global ACTH market was valued at approximately USD 2.1 billion. It is projected to exceed USD 4.7 billion by 2030, growing at a compound annual growth rate (CAGR) of 3.7% from 2022 to 2030[1][3][4].

Regional Dominance

North America currently dominates the global ACTH market, largely due to the high adoption rate of Acthar Gel and other ACTH products, as well as the high cost of these drugs in the region. This trend is expected to continue during the forecast period[1][3][4].

Emerging Markets

The Asia Pacific region is identified as the fastest-growing market for ACTH. This growth is attributed to increasing awareness about various diseases, favorable medical reimbursement policies, and the availability of synthetic ACTH (tetracosactide)[1][3].

Market Drivers

Increasing Usage of ACTH Products

The application of ACTH has significantly increased over the past few years, driven by its therapeutic use in treating conditions such as nephrotic syndrome, ophthalmology, rheumatology, Addison disease, Cushing syndrome, and Cushing disease. This increased usage is a major driver for the market[1].

Rise in Chronic Diseases

The growing incidence of chronic diseases, including neurological disorders, is a key factor driving the demand for ACTH. The hormone is used therapeutically to treat conditions like multiple sclerosis and infantile spasms[3][4].

Investments in Research & Development

Major players in the market are investing heavily in research and development to develop new and more effective ACTH products. This investment is expected to propel the market forward[1][3][4].

Market Opportunities

Technological Advancements

The need for newer and technologically enhanced products is on the rise, driven by the quest for better treatment efficiency. This presents opportunities for companies to innovate and expand their product portfolios[1].

Growing Awareness and Healthcare Infrastructure

In regions like Europe, the market is expected to expand due to increased awareness about various diseases, favorable medical reimbursement policies, and well-established healthcare facilities. The CAGR for the European market is projected to be around 6.98% from 2022 to 2030[1].

Market Challenges

Side Effects

Despite the growth, the market faces challenges such as the potential side effects of ACTH, including bone loss, indigestion, and muscle weakness. Manufacturers are working to create awareness about the management of these side effects[3].

High Costs and Skilled Professionals

The high costs associated with research and development, along with a shortage of skilled professionals, are factors that restrict the market's full potential growth[4].

Key Players

The global ACTH market is competitive, with several prominent players including:

• Mallinckrodt plc
• Pfizer, Inc.
• Novartis AG
• Merck KGaA
• Ferring B.V.
• Avantor, Inc.
• Viatris, Inc.
• Hikma Pharmaceuticals plc
• ANI Pharmaceuticals, Inc.
• BCN Peptides S.A.U.
• Piramal Pharma Solutions
• PolyPeptide Group[1][3][4].

Recent Developments

In January 2022, ANI Pharmaceuticals, Inc. announced the U.S. commercial availability of Purified Cortrophin Gel (Repository Corticotropin Injection USP) 80 U/mL, which is used to treat chronic autoimmune conditions such as acute exacerbations of multiple sclerosis and rheumatoid arthritis, as well as excess urine protein due to nephrotic syndrome[4].

Financial Projections

By 2030, the global ACTH market is expected to reach USD 4.7 billion, with a CAGR of 3.7% from 2022 to 2030. Another projection suggests the market could reach USD 1.95 billion by 2031, growing at a CAGR of 4.3% from 2023 to 2031[1][3][4].

Segmentation

The ACTH market is segmented based on indication, distribution channel, and region. The segmentation helps in understanding the specific needs and trends within different segments, allowing for targeted strategies by market players[3][4].

Distribution Channels

The availability of ACTH products through various distribution channels, including online platforms, is increasing. This accessibility is crucial for the screening and treatment of patients presumed to have adrenocortical insufficiency[3].

Conclusion

The global Adrenocorticotropic Hormone (ACTH) market is poised for significant growth, driven by increasing usage, investments in R&D, and the rising incidence of chronic diseases. Despite challenges such as side effects and high costs, the market is expected to expand substantially over the next decade.

Key Takeaways

• The global ACTH market is projected to reach USD 4.7 billion by 2030.
• North America dominates the market, with the Asia Pacific region showing the fastest growth.
• Key drivers include the increasing usage of ACTH products and investments in R&D.
• Major players are focusing on developing new and more effective products.
• Side effects and high costs are significant challenges.

FAQs

What is the current market size of the global ACTH market?

The global ACTH market was valued at approximately USD 2.1 billion in 2021[1].

What is the projected growth rate of the global ACTH market?

The market is expected to grow at a CAGR of 3.7% from 2022 to 2030[1].

Which region dominates the global ACTH market?

North America currently dominates the global ACTH market[1][3][4].

What are the main therapeutic uses of ACTH?

ACTH is used therapeutically to treat conditions such as nephrotic syndrome, ophthalmology, rheumatology, Addison disease, Cushing syndrome, and Cushing disease[1].

Who are the key players in the global ACTH market?

Key players include Mallinckrodt plc, Pfizer, Inc., Novartis AG, Merck KGaA, Ferring B.V., Avantor, Inc., Viatris, Inc., and Hikma Pharmaceuticals plc[1][3][4].

Sources

1. Biospace: Adrenocorticotropic Hormone Market Size to Hit US$ 4.7 Billion by 2030.
2. Journal of Neuroscience: Corticotropin Releasing Factor (CRF) Coexpression in GABAergic Neurons.
3. Transparency Market Research: Adrenocorticotropic Hormone [ACTH] Market Overview 2031.
4. Growth Plus Reports: Adrenocorticotropic Hormone Market 2031.