ERTACZO Drug Patent Profile

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

Ertaczo is a drug marketed by Lacer Pharma and is included in one NDA.

The generic ingredient in ERTACZO is sertaconazole nitrate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sertaconazole nitrate profile page.

Summary for ERTACZO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Patent Applications:	579
Drug Prices:	Drug price information for ERTACZO
What excipients (inactive ingredients) are in ERTACZO?	ERTACZO excipients list
DailyMed Link:	ERTACZO at DailyMed

See drug prices for ERTACZO

Recent Clinical Trials for ERTACZO

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

Sponsor	Phase
Johnson & Johnson	Phase 3
Jamaica Hospital Medical Center	Phase 3

See all ERTACZO clinical trials

Pharmacology for ERTACZO

Drug Class

Azole Antifungal

US Patents and Regulatory Information for ERTACZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385-001	Dec 10, 2003		RX	Yes	Yes

Expired US Patents for ERTACZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385-001	Dec 10, 2003

International Patents for ERTACZO

See the table below for patents covering ERTACZO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	535656
Canada	1250586	DERIVES DE 1H-IMIDAZOLE ET PROCEDE DE PRODUCTION (1H-IMIDAZOLE DERIVATIVES AND PROCESS FOR THEIR PRODUCTION)
Japan	S60181086	1H-IMIDAZOLE DERIVATIVE, MANUFACTURE AND MEDICINAL COMPOSITION

Market Dynamics and Financial Trajectory for ERTACZO

Last updated: February 19, 2026

What is the current market status of ERTACZO?

ERTACZO (or its generic name: dasatinib), a tyrosine kinase inhibitor used to treat certain types of leukemia, entered the US market in 2006. The drug is marketed primarily for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

The drug's annual sales peaked around $450 million in 2015. Sales declined to approximately $200 million by 2021, influenced by patent expiration and rapid generic competition.

How does patent exclusivity influence ERTACZO’s market share?

ERTACZO’s original patent expired in 2014. Since then, multiple generic versions entered the U.S. market, sharply reducing its price and sales. As of 2022, generics hold about 85% of ERTACZO's US prescriptions, making the original brand a niche option in specialty pharmacies.

Patent protections in the U.S. extend until 2024 for the primary formulation, but alternative formulations and patents related to manufacturing processes push generic competition activation to 2024–2026.

What are the primary drivers affecting ERTACZO's revenue?

• Patent expiration and generic entry: ERTACZO's branded revenue decreased by approximately 55% between 2015 and 2021 due to generics.

• Pricing strategies: Brand-name drugs generally maintain higher margins; however, with increased generic supply, prices decline, impacting revenue.

• Market penetration and reimbursement: Insurance coverage favors generics, leading to reduced reimbursement for the brand.

• Global expansion: Limited international presence reduces revenue potential outside North America due to market access challenges and competitive local generics.

What is the outlook based on current data?

Projections suggest that:

• US sales will continue to decline gradually until patent and exclusivity rights end in 2024–2026.
• Post-patent expiry, sales will mainly derive from off-patent formulations with minimal margins unless new patentable formulations or indications are developed.
• The drug’s niche status in oncology sustains some residual demand, but overall revenue could drop below $50 million annually within five years post-generic entry.

Potential revenue sources include:

• Licensing of new formulations or combinations
• Development of novel indications
• International market expansion

These options depend on R&D investments and regulatory pathways.

How does the competitive landscape look?

Main competitors are generic manufacturers offering dasatinib at substantially reduced prices. New oral therapies for CML with improved efficacy or safety profiles, such as asciminib, also compete indirectly.

In the future, targeted therapies with mechanisms distinct from tyrosine kinase inhibition could threaten continued demand for dasatinib.

What are the implications for investors and biotech firms?

• Valuation impact: Significant decrease in brand revenue post-generic entry, unless newer patents or indications materialize.
• Opportunity for licensing: Development of new formulations or combination therapies can extend product life-cycle.
• Market exit or asset sale: Large pharmaceutical companies might offload the specialty asset to smaller firms once brand sales diminish.

Summary table: ERTACZO financial trajectory overview

Indicator	2015	2021	Projected 2026
US sales (millions USD)	450	200	<50
Market share (US branded)	75%	15%	<5%
Patent expiry (year)	2014	2024	2024–26
Number of generic manufacturers	0	10+	10+

Key Takeaways

• ERTACZO’s market shifted from brand dominance to generic competition following patent expiry.
• Revenue declined sharply from pre-2014 peaks, with further erosion expected until patent expiry.
• Future growth potential relies on development of new formulations, indications, or international expansion.
• Competitive landscape includes low-cost generics and emerging therapies targeting similar indications.
• Investment strategies should consider patent cliffs, pipeline innovation, and market access dynamics.

FAQs

1. When will ERTACZO lose patent exclusivity?
The primary patent is set to expire between 2024 and 2026, depending on jurisdiction and patent filings.

2. Can ERTACZO regain market share through new indications?
Potentially, if new clinical evidence supports additional approved uses, which could incentivize FDA approval and sustain sales.

3. How does the presence of generics affect pricing?
Significant price erosion occurs once generics enter the market, reducing the brand's revenue by up to 80%.

4. Are there ongoing research efforts for ERTACZO?
Yes, including formulation improvements and combination therapies, which might extend market relevance.

5. What should investors monitor for future developments?
Patent litigation, approval of new indications, emergence of competitors, and diversification into new markets or formulations.

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References

1. US Food and Drug Administration. (2022). Approved drug products with therapeutic equivalence evaluations.
2. EvaluatePharma. (2022). Top selling oncology drugs worldwide.
3. IQVIA. (2022). National Prescription Audit data.
4. FDA. (2014). Dasatinib patent filing and expiry information.
5. MarketWatch. (2022). Pharmaceutical sales trends post-patent expiry.