BAXDELA Drug Patent Profile

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

Baxdela is a drug marketed by Melinta and is included in two NDAs. There are thirteen patents protecting this drug.

This drug has one hundred and seventy-two patent family members in forty-two countries.

The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.

DrugPatentWatch^® Generic Entry Outlook for Baxdela

Baxdela was eligible for patent challenges on June 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2031. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BAXDELA

International Patents:	172
US Patents:	13
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BAXDELA

US Patents and Regulatory Information for BAXDELA

BAXDELA is protected by thirteen US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,728,143.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	8,252,813		Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	8,273,892			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	7,635,773		Y

International Patents for BAXDELA

When does loss-of-exclusivity occur for BAXDELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BAXDELA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2346855
Japan	2018052991
Brazil	PI0921705

Supplementary Protection Certificates for BAXDELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	21C1006	France		PRODUCT NAME: DELAFLOXACINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219
3214083	C20210002 00366	Estonia		PRODUCT NAME: DELAFLOKSATSIIN;REG NO/DATE: EU/1/19/1393 19.12.2019
3214083	2021/002	Ireland		PRODUCT NAME: DELAFLOXACIN OR A SALT OR ESTER THEREOF, INCLUDING DELAFLOXACIN MEGLUMINE; NAT REGISTRATION NO/DATE: EU/1/19/1393 20191216; FIRST REGISTRATION NO/DATE: EU/1/19/1393 16/12/2019 (12/10/2022) JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2474)

Investment Scenario and Fundamentals Analysis for BAXDELA (Qtrypta)

Last updated: February 19, 2026

What is BAXDELA and Its Market Position?

BAXDELA is the brand name for moxetumomab pasudotox-tdfk, a recombinant immunotoxin developed by Affimed and MedImmune/AstraZeneca. Approved by the FDA in September 2020 for relapsed or refractory hairy cell leukemia (HCL), this drug targets CD22-positive B-cells. Its market entrance addresses a niche in hematologic oncology, with limited competition and high unmet needs in refractory HCL cases.

Clinical and Regulatory Fundamentals

Indication:

• Adult patients with relapsed or refractory hairy cell leukemia (HCL)
• Approved based on durable complete remission in clinical trials

Efficacy:

• Demonstrated overall response rate (ORR): 87%
• Complete remission (CR) rate: 36%
• Median duration of response: over 9 months

Safety Profile:

• Common adverse events include fatigue, nausea, and infusion-related reactions
• No new safety signals reported post-approval

Regulatory Status:

• FDA approval obtained in 2020
• Fast-tracked due to limited treatment options in refractory HCL
• Pending some regulatory review in Europe, but no formal approval announced

Market and Competitive Landscape

Market Size:

• HCL prevalence: roughly 1,000 new cases annually in the U.S.
• Market potential estimates: $200-300 million in North America annually

Key Competitors:

• Cladribine (Leustatin) and Pentostatin (Nipent), which have broader hematologic indications but are less effective in refractory cases
• Limited alternative options for refractory patients; no direct biologic competitors approved specific for relapsed/refractory HCL akin to BAXDELA

Pricing and Reimbursement:

• List price (approximate): $60,000 per treatment course
• Reimbursement strategies focus on insurance and Medicare for refractory cases

Commercial and Market Access Outlook

Market Penetration:

• Controlled by disease rarity and clinician awareness
• Initial launch driven by specialized hematology-oncology clinics
• Expansion depends on clinical data, reimbursement, and physician adoption

Pharmacoeconomic Considerations:

• Cost-effectiveness linked to durability of response
• Comparatively higher efficacy in refractory HCL drives value claims

Development and Commercial Risks

Pipeline:

• No major indications broader than HCL are in late-stage development
• Expanding label to other B-cell malignancies remains unlikely soon

Regulatory and Market Risks:

• Off-label use restrictions, given narrow approved indication
• Limited market size constrains revenue potential
• Competition from emerging biologics or biosimilars remains minimal but could impact long-term pricing

Manufacturing:

• Complex biologic production increases risk of supply chain disruptions
• AML and other hematologic therapies could introduce alternate treatments

Financial and Investment Considerations

Revenue Potential:

• Limited by disease prevalence and market penetration
• Peak sales estimate: $200-300 million annually, assuming rapid uptake in specialty centers

Cost Structure:

• High manufacturing costs typical of biologics
• R&D investments mainly in clinical trials and regulatory processes

Investment Risks:

• Market access challenges
• Clinical failure in expanding indications
• Regulatory delays or restrictions

Key Takeaways

1. Market niche: BAXDELA's primary market is relapsed/refractory HCL, with limited competition.
2. Regulatory success: The 2020 FDA approval confirms a validated therapeutic approach but restricts use to specific patient populations.
3. Revenue outlook: Potential peaks at ~$200 million annual sales, constrained by rarity and market access.
4. Long-term prospects: Limited pipeline expansion reduces growth potential; high manufacturing costs increase profitability risks.
5. Competitive dynamics: Currently limited; future threats could arise from personalized biologics or biosimilars.

FAQs

1. What are the main factors driving BAXDELA's adoption?
   Clinical efficacy in refractory HCL, physician familiarity with biologic therapies, and lack of effective alternatives.

2. How significant is the market for BAXDELA?
   The total addressable market in the U.S. is approximately 1,000 new HCL cases annually, with potential revenue of $200-300 million.

3. What are the major hurdles for BAXDELA's growth?
   Limited indication scope, high production costs, regulatory restrictions, and the small patient population.

4. Could BAXDELA expand to broader indications?
   Expansion appears unlikely in the near term without additional clinical data; targeting other B-cell malignancies faces significant hurdles.

5. What is the outlook for competitors?
   No current direct biologic competitors for refractory HCL; emerging treatments could alter this landscape but are not imminent.

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References

1. Food and Drug Administration. (2020). FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia. https://www.fda.gov/
2. MarketWatch. (2022). Hematologic cancer therapeutics market analysis.
3. ClinicalTrials.gov. (2022). BAXDELA clinical trials and efficacy data.
4. IQVIA. (2021). Hematology-oncology drug sales analysis.
5. European Medicines Agency. (2022). Pending review updates for BAXDELA.