ACTH Drug Patent Profile

Which patents cover Acth, and when can generic versions of Acth launch?

Acth is a drug marketed by Parkedale, Sanofi Aventis Us, and Mallinckrodt Ard. and is included in three NDAs. There is one patent protecting this drug.

The generic ingredient in ACTH is corticotropin. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.

DrugPatentWatch^® Generic Entry Outlook for Acth

Indicators of Generic Entry

Summary for ACTH

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	7
Drug Prices:	Drug price information for ACTH
DailyMed Link:	ACTH at DailyMed

See drug prices for ACTH

US Patents and Regulatory Information for ACTH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parkedale	ACTH	corticotropin	INJECTABLE;INJECTION	008317-002	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
Mallinckrodt Ard	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-004	Feb 29, 2024		RX	Yes	Yes
Parkedale	ACTH	corticotropin	INJECTABLE;INJECTION	008317-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-002	Approved Prior to Jan 1, 1982		DISCN	No	No

ACTH Market Analysis and Financial Projection Experimental

The Adrenocorticotropic Hormone (ACTH) market is experiencing significant growth driven by various market dynamics and financial factors. Here are the key points:

Market Size and Growth

• Market Value: The global ACTH market size was valued at USD 2.1 billion in 2021 and is predicted to exceed USD 4.7 billion by 2030, with a compound annual growth rate (CAGR) of 3.7% from 2022 to 2030[1][3].
• Segmentation: The market is segmented by source (natural and synthetic), indication (rheumatology, neurology, nephrotic syndrome, ophthalmology, and others), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies)[4].

Market Drivers

• Increased Usage: The application of ACTH has increased significantly over the past few years, leading to a huge demand for ACTH products. It is administered for treating various conditions such as nephrotic syndrome, ophthalmology, rheumatology, Addison disease, Cushing syndrome, and Cushing disease[1][4].
• Rising Healthcare Expenditure: Improving healthcare infrastructure and rising healthcare expenditure are significant factors influencing the growth rate of the ACTH market[4].
• Awareness and Reimbursement Policies: Increase in awareness about various diseases and favorable medical reimbursement policies are driving the market in regions like Europe[1].

Market Opportunities

• North America Dominance: North America dominated the global ACTH market in 2020 and is likely to continue this trend during the forecast period due to high adoption rates of Acthar Gel and high drug costs[1][3].
• European Expansion: The market in Europe is projected to expand at a CAGR of 6.98 from 2022 to 2030, driven by factors like increased awareness, favorable reimbursement policies, availability of synthetic ACTH, and well-established healthcare facilities[1].

Market Challenges

• High Drug Costs: The high cost associated with drug development and distribution is a significant restraint on the market's growth rate[4].
• Side Effects and Lack of Awareness: Side effects of ACTH and lack of awareness about its management are also acting as market restraints[4].

Financial Trajectory

• Sales Revenue: Major players in the market, such as Mallinckrodt plc, have generated significant revenue from ACTH sales. For example, Mallinckrodt collected nearly $6 billion in net sales from Acthar from 2014 through 2019[2].
• Price Increases: The price of Acthar has increased significantly since its acquisition by Mallinckrodt, with a rise from $40 a vial to over $31,000 a vial[2].
• Research and Development: Key players are investing heavily in research and development to develop new drugs and enhance existing ones, which is anticipated to propel the global ACTH market[1].

Key Players

• Mallinckrodt plc: One of the prominent players in the ACTH market, known for its high-priced drug Acthar Gel. The company has faced criticism for its aggressive pricing strategies and lack of transparency in pricing adjustments[2].
• Pfizer, Inc., Novartis AG, Merck KGaA, Ferring B.V., Avantor, Inc., Viatris, Inc., Hikma Pharmaceuticals plc: Other major players operating in the global ACTH market[1][3].

Future Developments

• New Product Launches: Manufacturers are working on developing new products and enhancing existing ones. For instance, Ani Pharmaceuticals has launched a 1-mL vial size of Cortrophin Gel for treating acute gouty arthritis flares and is planning to launch a Pre-Filled Syringe for Cortrophin Gel in the first half of 2025[5].

Key Takeaways

1. Market Growth: The global ACTH market is expected to grow significantly, driven by increased usage, rising healthcare expenditure, and favorable reimbursement policies.
2. Market Segmentation: The market is segmented by source, indication, and distribution channel, offering various opportunities for growth.
3. Financial Performance: Major players have generated substantial revenue from ACTH sales, but high drug costs and side effects are significant restraints.
4. Future Developments: Ongoing research and development activities, along with new product launches, are expected to propel the market forward.

FAQs

1. What is the expected market size of the global ACTH market by 2030?

   • The global ACTH market is expected to exceed USD 4.7 billion by 2030[1].

2. What is the CAGR of the global ACTH market from 2022 to 2030?

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

3. Which region dominates the global ACTH market?

   • North America dominates the global ACTH market, followed by Europe[1][3].

4. Who are some of 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].

5. What are some of the challenges faced by the global ACTH market?

   • High drug costs, side effects of ACTH, and lack of awareness about its management are significant challenges faced by the market[4].