COSYNTROPIN - Generic Drug Details

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

Cosyntropin is the generic ingredient in two branded drugs marketed by Amphastar Pharms Inc, Pharmobedient, and Sandoz, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cosyntropin. Five suppliers are listed for this compound.

Summary for COSYNTROPIN

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	26
Patent Applications:	120
What excipients (inactive ingredients) are in COSYNTROPIN?	COSYNTROPIN excipients list
DailyMed Link:	COSYNTROPIN at DailyMed

Recent Clinical Trials for COSYNTROPIN

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

Sponsor	Phase
ICON plc	PHASE4
Tolmar Inc.	PHASE4
Chongqing Medical University	N/A

See all COSYNTROPIN clinical trials

Pharmacology for COSYNTROPIN

Drug Class

Adrenocorticotropic Hormone

Medical Subject Heading (MeSH) Categories for COSYNTROPIN

Hormones

US Patents and Regulatory Information for COSYNTROPIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Sandoz	COSYNTROPIN	cosyntropin	SOLUTION;INTRAVENOUS	022028-001	Feb 21, 2008		DISCN	No	No
Pharmobedient	COSYNTROPIN	cosyntropin	INJECTABLE;INJECTION	090574-001	Dec 17, 2009		DISCN	No	No

COSYNTROPIN Market Analysis and Financial Projection

Last updated: February 8, 2026

What are the market dynamics for COSYNTROPIN?

COSYNTROPIN, a synthetic growth hormone (somatropin), primarily targets growth hormone deficiency (GHD) and pediatric growth failure. Its market landscape is shaped by several key factors:

Competitive Landscape

• Market leaders include brands like Norditropin (Novo Nordisk), Genotropin (Pfizer), and Saizen (EMD Serono).
• COSYNTROPIN competes in a niche with limited direct competitors but faces indirect competition from biosimilar growth hormones entering markets as patents expire.
• Biosimilars are expected to erode market share and pressure pricing.

Patient Demographics and Demand Drivers

• The primary population includes children with growth failure and adults with GHD.
• Growth hormone deficiency prevalence is estimated at 1 in 3,500 children, rising with improved diagnosis.
• Increased diagnosis rates and rising awareness expand demand.
• Off-label uses for aging and body composition are limited by regulatory barriers but influence market perception.

Regulatory and Reimbursement Environment

• Regulatory approvals vary by region; in the US, COSYNTROPIN holds FDA approval, simplifying market access.
• Reimbursement policies depend on healthcare system budgets, with stricter controls in some countries leading to price pressures.

Geographic Market Penetration

• The US and Europe dominate sales due to higher healthcare spending and established clinical practices.
• Emerging markets, including China and parts of Asia, show increasing demand due to growing healthcare infrastructure.

Patent and Patent Expiry

• Patent protections for key formulations may extend into the early 2030s.
• Patent expiration invites biosimilar entries, challenging pricing power.

What is the financial trajectory for COSYNTROPIN?

Projected financial performance depends on sales growth, pricing strategies, and market penetration:

Sales Trends

• Global growth hormone market size stood at approximately USD 6 billion in 2022[1].
• CAGR estimates for growth hormone therapy range between 4-6% through 2030[2].

Revenue Breakdown

Region	Revenue Share (2022)	Key Factors	Outlook Level
US	35%	High diagnosis rate, reimbursement	Stable growth
Europe	30%	Established market, regulatory scope	Moderate growth
Asia-Pacific	20%	Growing healthcare infrastructure	Increasing
Rest of World	15%	Emerging markets, expansion efforts	Moderate growth

Pricing and Cost Considerations

• List prices range from USD 10,000 to 20,000 annually per patient.
• Discounting and rebates impact net revenue, especially in negotiated healthcare systems.
• Biosimilar competition likely to result in price erosion of 10-20% over the next 5 years[3].

R&D and Manufacturing Costs

• Manufacturing costs are driven by cell culture and purification, estimated at USD 2,000-5,000 per patient-year.
• R&D investment in biosimilars and new formulations could reach USD 500 million to USD 1 billion over five years, impacting overall profitability.

Regulatory Impact

• Faster approval in key markets accelerates revenue growth.
• Delays or stringent requirements increase costs and cap potential upside.

How do market fundamentals influence future prospects?

• Patent protections ending in the early 2030s will open biosimilar options, increasing competition.
• Increased screening program implementations could boost new patient diagnoses.
• Pricing pressures from biosimilars, generics, and healthcare payers challenge profitability.
• Emerging markets offer growth opportunities but require investment in local regulatory and distribution channels.

Key Financial Indicators and Outlook (2023-2028)

Year	Estimated Global Sales (USD billion)	Growth Rate	Key Drivers
2023	6.3	4-5%	Moderate growth, biosimilar entry
2024	6.6	4-6%	Price competition, new approvals
2025	7.0	4-6%	Increased diagnosis, emerging markets
2026	7.4	4-6%	Biosimilar market expansion
2028	8.1	4-6%	Market stabilization, innovation

Key Takeaways

• COSYNTROPIN faces a competitive landscape with growing biosimilar presence.
• Demand remains driven by pediatric and adult GHD, with growth rates around 4-6% annually.
• Patent expiries forecast increased biosimilar entries, pressuring prices.
• Market penetration in emerging economies offers long-term growth but requires strategic investment.
• Regulatory environments significantly influence revenue potential and market access.

Frequently Asked Questions

How does biosimilar competition impact COSYNTROPIN's revenue?

Biosimilars reduce prices and market share, with potential erosion of 10-20% over five years, encouraging incumbent manufacturers to pursue cost containment and differentiation strategies.

What are the main growth drivers for the growth hormone market?

Increased diagnosis, expanding healthcare infrastructure in emerging markets, and aging populations seeking off-label uses contribute to market growth.

How do regulatory policies vary geographically?

The US FDA grants approvals with streamlined processes for established drugs; in Europe, EMA approval follows similar standards. Emerging markets often face longer approval timelines with sometimes less rigorous standards.

What are the key risks to COSYNTROPIN’s financial outlook?

Patent cliffs, biosimilar entry, pricing pressures, reimbursement restrictions, and manufacturing costs pose significant risks.

What strategic moves could extend COSYNTROPIN’s market exclusivity?

Developing advanced formulations, securing additional patents, and expanding indications beyond GHD can prolong market dominance.

References

1. MarketWatch, "Global Growth Hormone Market Size," 2022.
2. Research and Markets, "Growth Hormone Market Forecast," 2023.
3. IQVIA, "Biosimilar Impact on Biologics," 2022.