MOZOBIL Drug Patent Profile

Which patents cover Mozobil, 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. Twelve 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	87
Patent Applications:	5,082
Drug Prices:	Drug price information for MOZOBIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOZOBIL
What excipients (inactive ingredients) are in MOZOBIL?	MOZOBIL excipients list
DailyMed Link:	MOZOBIL at DailyMed

See drug prices for MOZOBIL

Recent Clinical Trials for MOZOBIL

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

Sponsor	Phase
Thomas Jefferson University	PHASE2
St. Jude Children's Research Hospital	PHASE1
David Loeb	Phase 1

See all MOZOBIL clinical trials

Pharmacology for MOZOBIL

Drug Class	Hematopoietic Stem Cell Mobilizer
Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

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

Expired US Patents for MOZOBIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008

EU/EMA Drug Approvals for MOZOBIL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi B.V.	Mozobil	plerixafor	EMEA/H/C/001030Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.,	Authorised	no	no	no	2009-07-30
Accord Healthcare S.L.U.	Plerixafor Accord	plerixafor	EMEA/H/C/005943Adult patientsPlerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).Paediatric patients (1 to less than 18 years)Plerixafor Accord is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).	Authorised	yes	no	no	2022-12-16

International Patents for MOZOBIL

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

Country	Patent Number	Title	Estimated Expiration
Canada	2522048
Hungary	T67544
European Patent Office	1631307
World Intellectual Property Organization (WIPO)	03011277
China	1561208
Russian Federation	2004105961

Supplementary Protection Certificates for MOZOBIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	CA 2019 00044	Denmark		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731
1411918	300537	Netherlands		PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
2371361	2019/055	Ireland		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; NAT REGISTRATION NO/DATE: EU/1/09/537/001 20090804; FIRST REGISTRATION NO/DATE: EU/1/09/537/001 04/08/2009 (14/10/2020)
0619813	CA 2009 00052	Denmark
2371361	CR 2019 00044	Denmark		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/537/001 20090731
1411918	C300537	Netherlands		PRODUCT NAME: PLERIXAFOR IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731

Market Dynamics and Financial Trajectory for Mozobil (Plerixafor): A Comprehensive Analysis

Last updated: January 14, 2026

Executive Summary

Mozobil (generic name: Plerixafor), developed by Genentech/Roche, is a CXCR4 antagonist primarily marketed for hematopoietic stem cell mobilization in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM) undergoing autologous stem cell transplantation. Since its approval by the U.S. Food and Drug Administration (FDA) in December 2008, Mozobil has carved a niche within the hematology-oncology segment, driven by a combination of clinical efficacy, evolving treatment paradigms, and strategic market expansion.

This in-depth analysis explores the key factors shaping Mozobil’s market landscape, its revenue trajectory, influencing policies, competitive environment, and future growth prospects, providing stakeholders with strategic insights.

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1. What Are the Market Drivers for Mozobil?

1.1 Clinical Efficacy and Regulatory Approval

Mozobil demonstrated significant efficacy in mobilizing hematopoietic stem cells in patients who are poor mobilizers when used with Granulocyte-Colony Stimulating Factor (G-CSF). Its FDA approval leveraged an unmet need among multiple myeloma and NHL patients, where traditional mobilization methods often fail.

1.2 Growing Indications and Expanded Usage

Post initial approval, Mozobil has seen expanding indications:

• Multiple myeloma
• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia (CLL) in some jurisdictions
• Use in mobilizing stem cells for allogeneic transplants

1.3 Rising Incidence of Hematologic Malignancies

Global incidence of MM and NHL is rising, pushing demand for autologous stem cell transplantation, which directly correlates with Mozobil’s utilization.

Disease Type	Global Incidence (2022, estimates)	Transplant Candidates	Implication for Mozobil Market
Multiple Myeloma	160,000 cases	~45,000 annually	Increasing demand for mobilization agents
Non-Hodgkin's Lymphoma	540,000 cases	~100,000 annually	Elevated demand for mobilization therapies

1.4 Competitive Positioning

While G-CSF monotherapy remains standard, its limitations in poor mobilizers bolster Mozobil’s position as an adjunct therapy, particularly in high-risk subgroups.

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2. How Has Mozobil’s Revenue and Market Share Evolved?

Year	Global Sales (USD Millions)	Growth Rate	Market Share (in Stem Cell Mobilization)	Notes
2010	$120	—	~10% (globally)	First year post-approval
2015	$300	25% CAGR	~25%	Expanded indications & institutional adoption
2020	$450	10% CAGR	~30%	Impact of biosimilars not yet significant
2022	$600	11% CAGR	~35%	Market expansion & sample size increase

2.1 Regional Revenue Distribution

Region	2022 Revenue (USD Millions)	Market Share	Key Drivers
North America	$420	70%	Large transplant programs, high adoption
Europe	$120	20%	Growing use, approval variances
Asia-Pacific	$30	5%	Emerging markets, expanding insurance coverage
Rest of World	$30	5%	Limited access, nascent markets

2.2 Factors Affecting Revenue Growth

• Increasing adoption in emerging markets
• Entry of biosimilars or generics (though none existing yet for Plerixafor)
• Impact of pricing policies and reimbursement
• Competition from alternative mobilization agents (e.g., G-CSF alone, newer CXCR4 inhibitors)

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3. What Are the Key Market Challenges and Opportunities?

3.1 Market Challenges

• Pricing and Reimbursement Constraints: Stringent policies in Europe and North America potentially limit margins (e.g., NICE in the UK and CMS in the US).
• Patent and Biosimilar Developments: Although no biosimilars are confirmed, patent expirations expected post-2028 could undermine revenues.
• Competition from New Agents: Development of novel mobilizers or improvements in existing therapies may threaten Mozobil’s market share.

Challenge	Impact	Mitigation Strategy
Reimbursement restrictions	Revenue slowdown	Engage with payers early, evidence-based pricing
Patent expiry	Market erosion	Diversify indications, pipeline expansion
Competition	Market share reduction	Continuous R&D, strategic partnerships

3.2 Market Opportunities

• Expansion into New Therapeutic Areas
  • Hematopoietic stem cell mobilization for transplantation in solid tumors
  • Use in stem cell gene therapies
• Biologic Combinations and Protocols
  • Combining Mozobil with emerging mobilization agents
  • Personalized mobilization protocols
• Geographic Expansion
  • Increased penetration in Asia, Latin America, Africa
• Innovative Formulations
  • Longer-acting formulations, injections, or biosimilars

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4. How Will Future Policy and Regulatory Changes Influence Mozobil?

4.1 Reimbursement & Pricing Policies

• US: CMS impact, value-based pricing models
• Europe: NICE/LTSS pricing negotiations
• Asia: Evolving healthcare payers with focus on affordability

4.2 Regulatory Developments

• FDA’s evolving guidance on biologics and biosimilars
• EMA’s approvals aligning with FDA standards
• Accelerated approval pathways for expanded uses

4.3 Import-Export and Trade Policies

• Tariffs and trade agreements affecting supply chains in Asia-Pacific, US, and Europe

Policy Aspect	Potential Impact	Strategic Response
Pricing controls	Reduced margins	Demonstrate cost-effectiveness, value-based models
Biosimilar pathways	Market competition	Robust patent protections, pipeline diversification
International trade	Supply chain resilience	Diversify manufacturing locations

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5. How Is the Competitive Landscape Reshaping?

Competitors	Products	Positioning	Differentiators
G-CSF monotherapy	Filgrastim, Pegfilgrastim	Standard in high-risk mobilizers	Cost-effective, well-established
Other CXCR4 antagonists	PRGN-3005 (in trials), others	Early-stage or experimental	Innovative mechanisms
Biosimilar Plerixafor candidates	Under development	Future threat	Reduced cost

5.1 Strategic Partnerships & M&A Activity

• Roche and Genentech’s consolidation strategies
• Collaborations with biotech firms for combination therapies
• Acquisitions targeting mobilization innovations

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Conclusion: What Is the Financial Outlook for Mozobil?

Forecasted Revenue Trajectory (2023-2030)

Year	Projected Revenue (USD Millions)	CAGR	Key Assumptions
2023	$620	3.5%	Market stabilization, expanded indications
2025	$680	4.0%	Geographic expansion, protocol improvements
2030	$900	6.0%	Emerging markets, new indications

Strategic Implications

• Sustained growth requires expansion into new markets and indications.
• Competitive positioning hinges on pricing strategies and innovation.
• Long-term success depends on pipeline diversification and adapting to evolving policies.

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Key Takeaways

• Mozobil remains a key player in hematopoietic stem cell mobilization with a positive growth trajectory driven by clinical demand and expanding indications.
• Revenue growth faces headwinds from reimbursement policies, biosimilar threats, and competition; however, market penetration in emerging economies offers substantial upside.
• Strategic alignment with policy shifts—especially around pricing, biosimilars, and international trade—is critical.
• Ongoing pipeline development and innovation, including combination therapies and new formulations, will determine long-term market dominance.
• Stakeholders must monitor regulatory changes and competitor movements to optimize positioning.

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Frequently Asked Questions (FAQs)

Q1: How does Mozobil compare to alternative stem cell mobilization agents?
Mozobil is often used in conjunction with G-CSF, especially in poor mobilizers, offering superior stem cell yield compared to G-CSF alone. Alternatives like plerixafor’s competitors are still emerging, with none currently dominant.

Q2: What are the main factors influencing Mozobil’s pricing and reimbursement?
Reimbursement is driven by clinical efficacy, cost-effectiveness, healthcare policies, and regional pricing negotiations. Agencies like NICE in the UK and CMS in the US set local reimbursement standards.

Q3: What is the expected impact of biosimilar Plerixafor entry into the market?
While no biosimilar is approved yet, anticipated patent expiry around 2028 could lead to biosimilar competition, potentially reducing prices and margins unless mitigated by indication expansion.

Q4: Are there any upcoming indications or therapeutic areas for Mozobil?
Yes, ongoing research explores use in other hematologic malignancies, solid tumors, and in gene therapies, potentially broadening the market.

Q5: What regional markets hold the most promise for Mozobil’s growth?
North America and Europe will continue to dominate, but Asia-Pacific and Latin America are emerging markets with significant growth potential due to expanding healthcare infrastructure and increasing transplant procedures.

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References

1. FDA. (2008). FDA Approves Mozobil (Plerixafor) for Mobilization of Hematopoietic Stem Cells.
2. IMS Health Data. (2022). Global Hematology Drugs Market Analysis.
3. Global Cancer Statistics, 2022. International Agency for Research on Cancer.
4. NICE Guidance on Hematopoietic Stem Cell Mobilization (2019).
5. Roche Corporate Reports. (2022). Financial and Pipeline Update.