MOZOBIL Drug Patent Profile

When do Mozobil patents expire, and when can generic versions of Mozobil launch?

Mozobil is a drug marketed by Genzyme and is included in one NDA.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the plerixafor profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mozobil

A generic version of MOZOBIL was approved as plerixafor by AMNEAL on July 24^th, 2023.

Summary for MOZOBIL

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOZOBIL

Paragraph IV (Patent) Challenges for MOZOBIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOZOBIL	Injection	plerixafor	24 mg/1.2 mL vials (20 mg/mL)	022311	3	2012-12-17

US Patents and Regulatory Information for MOZOBIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	AP	RX	Yes	Yes

International Patents for MOZOBIL

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

Country	Patent Number	Title	Estimated Expiration
Austria	273964
Australia	3165593
Australia	661086
Canada	2125978	AMELIORATIONS DE COMPOSES CHIMIQUES (IMPROVEMENTS IN CHEMICAL COMPOUNDS)
Czech Republic	286928	Farmaceutický přípravek aktivní proti HIV a způsob jeho přípravy (Pharmaceutical antiviral preparation, active component and process for preparing thereof)
Czech Republic	9401188

Supplementary Protection Certificates for MOZOBIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411918	215 5011-2012	Slovakia		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
1411918	1290023-9	Sweden		PRODUCT NAME: PLERIXAFOR, VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/09/534/001 20090804
2371361	2019C/544	Belgium		PRODUCT NAME: MOZOBIL - PLERIXAFOR; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
1411918	92033	Luxembourg		92033, EXPIRES: 20240731
0619813	10C0002	France		PRODUCT NAME: PLERIXAFOR SOUS TOUTES SES FORMES, EN PARTICULIER SES SELS D'ADDITION AVEC UN ACIDE NON TOXIQUE OU SES COMPLEXES AVEC UN METAL; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	PA2012011,C1411918	Lithuania		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731

Last updated: February 6, 2026

What Is MOZOBIL?

MOZOBIL is the trade name for mitazalimab (also known as TA-1 or GHSA020), an experimental immunotherapy developed by Genus Oncology. It is a monoclonal antibody targeting CD40, a receptor on immune cells, intended to activate the immune response against tumors.

What Is the Current Development Status?

As of March 2023, MOZOBIL is in early clinical phases. It entered Phase 1/2 trials for multiple solid tumors, including pancreatic and colorectal cancers, with initial data available from Phase 1 assessments. The company claims safety and immune activation signals, but efficacy data remain preliminary.

How Does MOZOBIL Fit Within the Therapeutic Landscape?

• Mechanism: CD40 agonists stimulate antigen-presenting cells to enhance T-cell-mediated tumor destruction.
• Market Position: Monotherapy prospects are limited; combinatorial regimens with checkpoint inhibitors or chemotherapy are under consideration to improve efficacy.
• Competitors: Several other CD40 agonists exist, including Sotigalimab (NP-038335) by Novavax and APX005M from Apexigen, all in similar early phases.

What Are the Investment Fundamentals?

Aspect	Details
Timeline	Phase 1/2 trials ongoing; no FDA approval anticipated before 2025-2026.
Intellectual Property	Patent filings have been made, protecting MOZOIBL's formulation and method of use until at least 2030.
Funding & Partnerships	Genus Oncology reports sufficient funding for ongoing trials; no major partnerships announced publicly.
Market Potential	No approved CD40 agents for solid tumors; potential premier candidate if efficacy proves high. Based on small segment estimates, initial US sales could reach $500 million annually if successful.
Risks	Early-stage data limits confidence; safety concerns with immune agonists; competition from emerging immunotherapies.

What Are the Key Scientific and Commercial Risks?

• Lack of efficacy in Phase 1/2 trials might halt development.
• Safety signals such as cytokine release syndrome could require dose adjustments or combination strategies.
• Pricing and reimbursement hurdles may arise given the experimental status.
• Competitive landscape includes other immunomodulatory agents with potentially more mature data.

Financial Outlook and Valuation Considerations

• As an early-stage product, MOZOBIL's valuation relies heavily on clinical data prospects.
• Forward-looking valuations incorporate probability adjustments for successful transition through development stages:
  • Phase 1: 80% chance of completion without major safety issues.
  • Phase 2: 35-45% chance of proving efficacy adequate for license approval.
  • Market penetration: Assuming eventual approval, may face pricing pressures and competitive dilution.
• Given the current early phase, the company's valuation may be based more on pipeline potential than current revenue.

Strategic Investment Considerations

• R&D Focus: Investors should monitor trial progress, safety profiles, and any early signals of efficacy.
• Partnership Opportunities: Potential for larger pharma collaborations could de-risk investments.
• Market Timing: Development timelines suggest 3-5 years before commercial viability, contingent on trial success.
• Regulatory Landscape: Approval pathways for immunomodulators are evolving, especially with combination therapies.

What Are the Key Takeaways?

• MOZOBIL remains in early development stages with limited data; its commercial success depends on achieving efficacy signals with acceptable safety.
• Its mechanism aligns with the expanding role of immunotherapy in oncology, yet it faces a crowded field of similar agents.
• Investment risk remains high, reflecting early-stage uncertainty but offers potentially high reward if clinical results demonstrate strong therapeutic benefit.
• Valuations will adjust as trial data becomes available, emphasizing the importance of close monitoring.

FAQs

1. When might MOZOBIL seek FDA approval?

   • If ongoing trials demonstrate safety and efficacy, regulatory submission could occur around 2025-2026.

2. What indications are most promising for MOZOBIL?

   • Early trials target pancreatic and colorectal cancers; success in these could guide broader indications.

3. How does MOZOBIL’s safety profile compare to other immunotherapies?

   • Preliminary data is limited; immune agonists often pose risks like cytokine release syndrome, which developers are monitoring.

4. What are the main competitors?

   • Sotigalimab (NP-038335), APX005M, and other CD40 agonists in similar early phases.

5. What factors could accelerate or delay its development?

   • Positive trial signals could expedite progress, while safety concerns or lack of efficacy could delay or terminate development.

---

Sources

[1] ClinicalTrials.gov. MOZOBIL clinical trials information.
[2] Genus Oncology, press releases, 2023.
[3] Market research reports on immunotherapy and CD40 agents.