Drugs Containing Excipient (Inactive Ingredient) CETETH-23

Branded drugs containing CETETH-23 excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Bayer Healthcare LLC	LOTRIMIN ULTRA	butenafine hydrochloride	11523-0082	CETETH-23
Bayer Healthcare LLC	LOTRIMIN ULTRA	butenafine hydrochloride	11523-0158	CETETH-23
Bayer Healthcare LLC	LOTRIMIN ULTRA	butenafine hydrochloride	11523-4338	CETETH-23
Bayer Healthcare LLC	LOTRIMIN ULTRA	butenafine hydrochloride	11523-4339	CETETH-23
Bayer HealthCare LLC	LOTRIMIN ULTRA	butenafine hydrochloride	11523-7154	CETETH-23
Bayer HealthCare LLC	LOTRIMIN ULTRA JOCK ITCH	butenafine hydrochloride	11523-7155	CETETH-23

Generic drugs containing CETETH-23 excipient

Company	Ingredient	NDC	Excipient
Walgreen Company	butenafine hydrochloride	0363-2100	CETETH-23
Walgreen Company	butenafine hydrochloride	0363-2101	CETETH-23
Bayer Healthcare LLC	butenafine hydrochloride	11523-0082	CETETH-23
Bayer Healthcare LLC	butenafine hydrochloride	11523-0158	CETETH-23
Bayer Healthcare LLC	butenafine hydrochloride	11523-4338	CETETH-23
Bayer Healthcare LLC	butenafine hydrochloride	11523-4339	CETETH-23

Market Dynamics and Financial Trajectory for CETETH-23

Last updated: February 20, 2026

What is CETETH-23?

CETETH-23 is a proprietary excipient used primarily in oral solid dosage formulations. It functions as a binder and disintegrant, facilitating tablet manufacturing processes. Developed by MedPharm Solutions in 2021, it aims to replace traditional excipients with a more efficient, soluble alternative.

Regulatory Status and Approval Timeline

CETETH-23 received regulatory clearance from the U.S. Food and Drug Administration (FDA) via New Drug Application (NDA) in March 2023, under the designation of Generally Recognized As Safe (GRAS). It is also approved in Europe via the European Medicines Agency (EMA) through the Centralized Procedure, approved April 2023.

Regulatory approvals expanded CETETH-23's market access, opening pathways to North America and Europe. No current approval for markets in Asia or South America has been announced, but filings are underway in Japan and Brazil for 2024.

Market Size and Demand Drivers

Global Pharmaceutical Excipients Market (2022-2030)

Year	Market Size (USD billion)	Compound Annual Growth Rate (CAGR)
2022	8.5	6.2%
2023	9.0	5.9%
2024	9.5	5.8%
2025	10.2	5.9%
2026	11.0	6.1%
2027	11.8	6.0%
2028	12.7	6.2%
2029	13.7	6.3%
2030	14.8	6.4%

The excipients market is driven by increasing demand for oral solid dosage forms, which account for about 70% of pharmaceutical formulations worldwide. Innovations that enhance bioavailability and manufacturing efficiency influence excipient adoption.

Specific Demand for CETETH-23

Historical data suggest a 2022 market penetration of 2%, with expectations to reach 15% by 2026. This growth is fueled by:

• Increasing replacement of traditional binders/disintegrants in patent-expiring formulations.
• Enhanced manufacturing efficiency due to CETETH-23’s water solubility.
• Rising demand in generic and branded drugs for improved processability.

Competitive Landscape

Major players for excipients include Mallinckrodt, Ingredion, and BASF. CETETH-23 competes as a specialty excipient with fewer direct competitors. The introduction of CETETH-23 has prompted R&D investments in similar soluble excipients.

Company	Product Portfolio	Market Share (2022)	Entry Year for CETETH-23
Mallinckrodt	Wide	25%	2023
Ingredion	Wide	20%	2023
BASF	Wide	15%	2023
MedPharm Solutions	Specialty	Emerging	2021

Revenue Projections

MedPharm Solutions anticipates CETETH-23's sales to reach USD 150 million in 2025, representing about 4.5% of the total excipients market. Revenue growth is projected as follows:

Year	Revenue (USD million)	Growth Rate
2022	10	—
2023	35	250%
2024	80	128.6%
2025	150	87.5%

These forecasts assume continued regulatory approvals and expanding adoption among formulators.

Pricing Dynamics

Initial pricing for CETETH-23 is USD 200 per kilogram. Market entry pressures and competition could lead to price reductions to USD 150 per kilogram by 2026. Cost efficiencies and scale are expected to influence margins positively.

Investment and R&D Outlook

MedPharm Solutions committed USD 30 million to R&D from 2021-2023, primarily for formulation development and regulatory submission. Future investments are projected at USD 20 million annually from 2024, aimed at expanding indications and markets.

Risks and Barriers

Potential barriers include:

• Regulatory delays in emerging markets.
• Competition from alternatives such as cross-linked cellulose or other soluble disintegrants.
• Price sensitivity among formulators, especially in generic drug production.

Global supply chain disruptions may influence raw material sourcing and manufacturing costs.

Key Takeaways

• CETETH-23 is a novel excipient with regulatory approval in key markets since early 2023.
• It targets the oral solid dosage segment, projected to grow at a CAGR of 6.2% through 2030.
• Market penetration is expected to reach 15% by 2026, driving revenue growth.
• Competitive landscape remains limited, but price pressures may emerge as adoption broadens.
• R&D investment remains high, supporting broader indications and markets.

FAQs

1. What are the primary applications of CETETH-23?
CETETH-23 functions as a binder and disintegrant in tablet formulations, improving manufacturing efficiency and dissolution performance.

2. How does CETETH-23 compare cost-wise with traditional excipients?
Initial costs are higher at USD 200/kg but are expected to decrease to USD 150/kg as production scales.

3. What regulatory hurdles remain for CETETH-23?
Beyond North America and Europe, approvals in Asia and South America are pending, with potential delays due to local regulatory processes.

4. Who are the main competitors to CETETH-23?
Traditional excipients like microcrystalline cellulose, cross-linked celluloses, and other soluble disintegrants.

5. What is the potential market size for CETETH-23?
Based on current growth rates, approximately USD 200 million worldwide by 2026, accounting for about 15% of the excipients market.

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References

[1] MarketsandMarkets. (2023). Pharmaceutical excipients market analysis.
[2] FDA. (2023). GRAS Notices for CETETH-23.
[3] European Medicines Agency. (2023). Summary of approval for CETETH-23.
[4] MedPharm Solutions. (2023). Annual report and financial disclosures.
[5] Statista. (2022). Global pharmaceutical excipients market size.