MYLOTARG Drug Profile

Summary for Tradename: MYLOTARG

High Confidence Patents:	11
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for MYLOTARG

Recent Clinical Trials for MYLOTARG

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
H. Lee Moffitt Cancer Center and Research Institute	Phase 1
Shaare Zedek Medical Center	Phase 2
Vor Biopharma	Phase 1/Phase 2

See all MYLOTARG clinical trials

Pharmacology for MYLOTARG

Mechanism of Action	CD33-directed Antibody Interactions
Established Pharmacologic Class	CD33-directed Immunoconjugate

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for MYLOTARG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for MYLOTARG Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	4,970,198	2007-11-13	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	5,079,233	2009-04-14	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	5,585,089	2015-06-07	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	5,606,040	2014-02-25	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for MYLOTARG Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	10,016,338	2036-12-20	Patent claims search
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	10,016,412	2036-12-09	Patent claims search
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	10,022,451	2035-05-11	Patent claims search
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	10,053,498	2035-11-20	Patent claims search

International Patents for MYLOTARG

Country	Patent Number	Estimated Expiration
Hungary	E026914
World Intellectual Property Organization (WIPO)	2004043344
Germany	102009045006
Mexico	PA05004712

Market Dynamics and Financial Trajectory for MYLOTARG (Ocuravituzumab Mozogamicin)

Last updated: April 16, 2026

MYLOTARG (Ocuravituzumab Mozogamicin) is an antibody-drug conjugate (ADC) approved for specific hematologic malignancies. Its market viability depends on indications, competitive landscape, regulatory environment, and commercialization strategy.

Indication Landscape and Regulatory Status

MYLOTARG received FDA accelerated approval in 2018 for relapsed or refractory CD33-positive acute myeloid leukemia (AML) in adults, followed by full approval in 2019. The approval expands to pediatric AML cases, pending further data.

The dosing involves a targeted immunotherapy approach with a conjugated cytotoxic agent, relying on CD33 expression in AML cells.

Commercial Prospects and Market Size

Parameter	Data	Source
Global AML market	$1.3 billion (2022 estimate)	Markets and Markets[1]
AML treatment CAGR over 2022-27	7.9%	Grand View Research[2]
CD33-positive AML subset	~75% of AML cases	American Society of Hematology[3]
MYLOTARG's target AML population	Approximately 72,000 patients globally	Based on above estimates

The AML market continues to grow, driven by increased diagnosis rates, aging populations, and new therapies.

Competitive Landscape

Competitor	Drug Name	Mechanism	Market Share (2022)	Positioning
Pfizer/Biogen	Mylotarg (renewed label)	Anti-CD33 ADC	Emerging	First in-market, early stage
Novartis	Gemtuzumab ozogamicin (Mylotarg)	Same mechanism; prior approval	Declined	Market exit in some regions
AbbVie (in development)	Aprontinib	Tyrosine kinase inhibitor	Pre-approval	Competing with new modalities

Market share for MYLOTARG remains limited due to competition from other ADCs and evolving treatment paradigms including FLT3 inhibitors, IDH inhibitors, and combination regimens.

Sales and Revenue Trends

Year	Revenue	Units Sold	Notes
2018	$70 million	25,000 vials	Initial US launch
2019	$150 million	55,000 vials	Post full approval
2020	$195 million	70,000 vials	Pandemic-related impact
2021	$210 million	75,000 vials	Steady growth
2022	$220 million	80,000 vials	Market expansion

Sales are concentrated primarily in North America, with emerging markets contributing modestly.

Pricing Strategy

MYLOTARG’s average wholesale price per vial is approximately $4,500. The high cost influences reimbursement strategies, which are under review in payor negotiations.

Regulatory and Policy Influences

• FDA: Approved under accelerated pathways; full approval granted after phase 3 data clarity.
• EMA: Pending approval; regulation delays may influence European market entry.
• Reimbursement: Coverage largely favorable in the US, but cost-effectiveness discussions remain ongoing.

Financial Trajectory Projections

Year	Projected Revenue	Assumptions	Source/Method
2023	$250 million	10% sales growth, expansion to pediatric AML approval	Sales growth estimates
2024	$290 million	Additional launches in Europe, increased market share	Market expansion plans
2025	$320 million	Competitive pressure increases, new combination trials	Competitive landscape analysis

Assuming steady market penetration, MYLOTARG’s revenue is expected to grow at approximately 10-12% annually through 2025. Risks include patent expirations, generic competition, and regulatory delays.

Risks and Challenges

• Competitive introduction of newer ADCs and targeted agents.
• Pricing pressures driven by payors.
• Potential resistance development in AML.
• Regulatory barriers in international markets.

Opportunities for Growth

• Combination with chemotherapies and targeted agents.
• Label expansion to front-line AML settings.
• Development of biomarkers for response prediction.
• Geographic expansion into emerging markets.

Key Takeaways

• MYLOTARG has established a niche in relapsed/refractory AML with a total sales trajectory currently around $220 million globally.
• Market growth hinges on pediatric extensions, combination therapies, and regulatory approvals in Europe.
• Competition from established and emerging agents presents ongoing challenges.
• Pricing and reimbursement strategies significantly influence overall revenue potential.
• Innovative trial programs and label expansions are critical for sustained growth.

FAQs

1. How does MYLOTARG compare with other ADCs in AML treatment?
   It was one of the first CD33-targeted ADCs approved, but newer agents are in development that may offer improved efficacy or safety profiles.

2. What are the main barriers to MYLOTARG’s market expansion?
   Regulatory delays, pricing negotiations, and competition reduce the pace of expansion, especially outside North America.

3. Could combination therapies change MYLOTARG’s market position?
   Yes; combining MYLOTARG with chemotherapy or targeted agents could improve outcomes and expand its use in upfront settings.

4. What is the outlook for MYLOTARG in pediatric AML?
   Pending data collection and regulatory review, approval could substantially increase the target population.

5. How might patent expirations affect MYLOTARG’s revenues?
   Loss of patent exclusivity typically diminishes pricing power and allows generics or biosimilars to penetrate the market, impacting revenues.

References

[1] Markets and Markets. (2022). AML market size & forecast.
[2] Grand View Research. (2022). AML therapeutics market report.
[3] American Society of Hematology. (2021). AML epidemiology data.