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. 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	87
Patent Applications:	5,755
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
St. Jude Children's Research Hospital	Phase 2

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
Hungary	9401786
Norway	2020003
Portugal	619813
Japan	2004538303
Norway	305984

Supplementary Protection Certificates for MOZOBIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411918	C 2012 019	Romania		PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731
2371361	C02371361/01	Switzerland		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63139 15.08.2014
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	LUC00139	Luxembourg		PRODUCT NAME: PLERIXAFOR EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN COMPLEXE METALLIFERE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
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)

Last updated: July 27, 2025

Introduction

Mozobil, branded as Plerixafor, is a myelopoietic agent utilized primarily to enhance the mobilization of hematopoietic stem cells (HSCs) in patients undergoing autologous stem cell transplantation (ASCT). Developed by Genzyme Corporation, which was acquired by Sanofi in 2011, Mozobil has established a niche within the hematology market, driven by its unique mechanism of action and clinical utility in stem cell mobilization. This report analyzes the evolving market landscape, competitive dynamics, regulatory influences, and financial trajectory shaping Mozobil’s commercial future.

Market Overview and Therapeutic Context

Clinical Role and Therapeutic Indications

Mozobil’s primary indication is to increase the yield of CD34+ hematopoietic stem cells during mobilization for collection in patients with non-Hodgkin’s lymphoma (NHL), multiple myeloma, and other hematologic malignancies undergoing autologous transplantation (FDA approval in 2008). Its mechanism involves antagonism of the CXCR4 receptor, disrupting the SDF-1/CXCR4 axis and facilitating stem cell egress from the bone marrow into peripheral blood.

Market Size and Growth Drivers

The global hematopoietic stem cell transplantation market, valued at approximately USD 5 billion in 2022, is projected to grow at a CAGR of 8-10% through 2027, driven by expanding indications, increasing aging populations, and technological advancements in transplantation procedures [1]. Mozobil's segment, although relatively niche, benefits from an expanding patient base and growing reliance on mobilization agents due to rising transplant procedures.

Key Competitors

While Mozobil's unique mechanism confers a competitive advantage, other mobilizing agents such as granulocyte colony-stimulating factor (G-CSF) alone, plerixafor biosimilars, and emerging agents present competition. Biosimilars are expected to impact pricing and market share, especially as patent exclusivity diminishes.

Market Dynamics

Regulatory Landscape and Approvals

Since FDA approval in 2008, Mozobil has received additional regulatory clearances globally, including in Europe, Japan, and emerging markets. Regulatory agencies have emphasized the importance of combinatorial use of G-CSF and Plerixafor, reinforcing its position as part of combination therapy regimens rather than a standalone agent.

Pricing and Reimbursement Trends

Pricing strategies for Mozobil are influenced by healthcare policies, reimbursement frameworks, and hospital procurement negotiations. The high cost of Plerixafor (approximately USD 15,000–20,000 per course) impacts its accessibility; however, reimbursement policies generally support its use owing to improved mobilization efficiency and patient outcomes.

Access and Adoption Barriers

Barriers include high drug costs, clinician familiarity with traditional mobilization protocols, and the need for precise patient stratification. Pharmacoeconomic models demonstrate that despite premium pricing, Mozobil’s ability to reduce mobilization failure and collection sessions justifies its cost in eligible patient populations.

Emerging Trends and Innovations

Recent research explores combination strategies (e.g., G-CSF and Plerixafor), alternative dosing regimens, and biomarker-driven patient selection to optimize mobilization success. Additionally, the development pipeline includes biosimilars and next-generation CXCR4 inhibitors, which could influence market share and pricing strategies.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Sanofi’s financial disclosures show that Mozobil’s annual sales peaked around USD 350–400 million post-2015, driven by high demand in the U.S. and Europe. However, recent years experienced slight stagnation or decline attributable to biosimilar entry and market saturation.

Factors Influencing Future Revenues

1. Patent Expiry and Biosimilar Competition: The expiration of key patents around 2023-2025 opens the door for biosimilars, potentially exerting significant downward pressure on prices.

2. Market Expansion: Increasing adoption in emerging markets presents upside potential, contingent on affordability and healthcare infrastructure.

3. Label Extensions and New Indications: Expanding Plerixafor’s labeled uses—for example, in mobilization for allogeneic transplants or leukemia treatments—could diversify revenue streams.

4. Pricing Strategies and Reimbursement Policies: Negotiations and health technology assessments (HTAs) in key markets will influence sales volumes and margins.

Projected Financial Pathway

Analysts project moderate revenue decline over the next 3–5 years post-biosimilar launch, with sales stabilizing or modestly growing in emerging markets. Revenue is expected to range between USD 200–250 million by 2026, assuming no significant new indications or formulations arrive. Strategic initiatives such as combination therapies, clinician education, and tailored patient selection will be critical to maintaining market relevance.

Strategic Considerations

• Collaborations and Licensing: Partnering with regional distributors or biosimilar developers can facilitate market entry and price competitiveness.
• Portfolio Diversification: Leveraging Plerixafor’s CXCR4 antagonism for other therapeutic areas—such as oncology or inflammatory diseases—could diversify revenue.
• Cost-Effective Adoption: Demonstrating pharmacoeconomic benefits through real-world evidence may promote reimbursement and uptake.

Conclusion

Mozobil operates within a specialized yet competitive segment shaped by advances in hematopoietic stem cell transplantation and evolving healthcare policies. While its high-cost profile and imminent biosimilar competition present challenges, strategic positioning—via indications expansion, combination protocols, and geographic diversification—can sustain its financial trajectory. Stakeholders should focus on innovation, regulatory navigation, and cost-effective access to optimize long-term profitability.

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Key Takeaways

• Mozobil's market is driven by increasing transplantation procedures and reliance on stem cell mobilization agents, with ongoing expansion in emerging regions.
• Patent expiration and biosimilar entry between 2023-2025 are poised to impact pricing and market share significantly.
• Strategic utilization of combination therapies and new indications can sustain revenue streams amid competitive pressures.
• Cost considerations, reimbursement policies, and clinical advocacy are critical factors influencing market access and adoption.
• Future growth hinges on innovation, geographic expansion, and demonstrating added value in clinical outcomes.

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Frequently Asked Questions (FAQs)

Q1: What are the primary factors affecting Mozobil’s market share in the coming years?
A1: Patent expiry leading to biosimilar competition, evolving reimbursement policies, clinician adoption patterns, and emerging alternative mobilization agents will influence Mozobil's market share.

Q2: How does biosimilar entry impact Mozobil’s revenue and pricing?
A2: Biosimilars typically lead to price reductions due to increased competition, which can reduce overall revenue unless offset by increased volume or new indications.

Q3: Are there promising developments that could extend Mozobil’s lifecycle?
A3: Yes, potential new indications, combination therapy protocols, and formulations (e.g., subcutaneous delivery) could prolong its clinical and commercial relevance.

Q4: How significant is regional market expansion for Mozobil’s future?
A4: Regional expansion, particularly in Asia and Latin America, offers substantial growth potential, contingent upon pricing strategies, local approval, and healthcare infrastructure.

Q5: What role does pharmacoeconomics play in Mozobil’s adoption?
A5: Demonstrating cost-effectiveness and the downstream savings from fewer mobilization failures can bolster reimbursement and clinician confidence, influencing adoption rates.

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References

[1] MarketsandMarkets. Hematopoietic Stem Cell Transplantation Market Forecast. 2022.