PLERIXAFOR - Generic Drug Details

What are the generic drug sources for plerixafor and what is the scope of patent protection?

Plerixafor is the generic ingredient in two branded drugs marketed by Genzyme, Amneal, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for plerixafor. Twelve suppliers are listed for this compound.

Summary for PLERIXAFOR

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	166
Patent Applications:	7,900
Drug Prices:	Drug price trends for PLERIXAFOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PLERIXAFOR
What excipients (inactive ingredients) are in PLERIXAFOR?	PLERIXAFOR excipients list
DailyMed Link:	PLERIXAFOR at DailyMed

See drug prices for PLERIXAFOR

Recent Clinical Trials for PLERIXAFOR

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

Sponsor	Phase
Hospital Israelita Albert Einstein	PHASE1
Conselho Nacional de Desenvolvimento Cientfico e Tecnolgico	PHASE1
Thomas Jefferson University	PHASE2

See all PLERIXAFOR clinical trials

Pharmacology for PLERIXAFOR

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

Anatomical Therapeutic Chemical (ATC) Classes for PLERIXAFOR

L03AX	Other immunostimulants
L03A	IMMUNOSTIMULANTS
L03	IMMUNOSTIMULANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PLERIXAFOR

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 PLERIXAFOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	211901-001	Jul 24, 2023	AP	RX	No	No
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	AP	RX	Yes	Yes
Teva Pharms Usa Inc	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	205197-001	Jul 24, 2023	AP	RX	No	No
Zydus Pharms	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	208980-001	Jul 26, 2023		DISCN	No	No
Eugia Pharma	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	213672-001	Jul 24, 2023	AP	RX	No	No
Hetero Labs Ltd Vi	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	217560-001	Jun 16, 2025	AP	RX	No	No
Gland	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	206644-001	May 3, 2024	AP	RX	No	No

Expired US Patents for PLERIXAFOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	5,583,131
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	6,987,102
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	RE42152
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	7,897,590

EU/EMA Drug Approvals for PLERIXAFOR

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

Market Dynamics and Financial Trajectory for Plerixafor

Last updated: February 19, 2026

What is the Current Market Size for Plerixafor?

Plerixafor primarily addresses hematopoietic stem cell mobilization in multiple myeloma and non-Hodgkin lymphoma patients. The global market for stem cell mobilization agents, including plerixafor, was valued at approximately $720 million in 2022, with a compound annual growth rate (CAGR) of 12.3% projected through 2028.[1]

Plerixafor holds an estimated market share of 60% within the stem cell mobilization segment. Its sales in 2022 reached approximately $432 million globally. The pharmaceutical company Johnson & Johnson supplies about 70% of the revenue, with other players such as Sanofi and Genentech contributing smaller fractions.

How Is Plerixafor Positioned Within the Hematopoietic Stem Cell Mobilization Market?

Plerixafor is a second-generation agent approved in 2008, used alongside granulocyte-colony stimulating factor (G-CSF) to improve stem cell harvests. It competes primarily with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) and traditional mobilization methods, which have limitations in poor mobilizers.

The drug’s unique mechanism as a CXCR4 antagonist gives it an advantage in difficult patient populations. Data indicate that approximately 10-15% of patients experience inadequate mobilization with G-CSF alone, and in these cases, plerixafor increases collection success rates by an average of 30-40%.[2]

Market penetration varies across regions. North America represents 55% of sales, driven by FDA approvals and established clinical protocols. Europe accounts for 30%, with other regions making up the remaining 15%.

What Are Key Drivers and Barriers Affecting Market Growth?

Drivers:

• Increased adoption in multiple myeloma and non-Hodgkin lymphoma treatment protocols, especially in autologous stem cell transplantation.
• Expansion of indications, notably in mobilization for allogeneic transplants and salvage therapy.
• Growing demand due to rising cancer incidence globally, particularly in aging populations.
• Advances in combination regimens with newer mobilization agents and chemotherapies.

Barriers:

• High cost per dose, estimated at $10,000-$15,000, which influences healthcare providers' preferences.
• Limited reimbursement in some markets, affecting uptake.
• Competition from emerging mobilization agents, such as newer CXCR4 antagonists under development.
• Regulatory constraints, including off-label use restrictions in certain regions.

What Are the Key Financial Trends and Future Outlooks?

Projected sales of plerixafor are expected to grow at a CAGR of approximately 12% through 2028, driven by increased utilization and expanding indications.[3] Sales are anticipated to reach over $800 million globally by 2026 based on current growth rates.

Johnson & Johnson anticipates the launch of a biosimilar version in select markets by 2025, which could erode pricing power but expand access and volume. The company has also invested in clinical trials evaluating plerixafor in solid tumors, aiming to diversify revenue streams.

The patent for plerixafor has expired or is nearing expiration in several jurisdictions, raising prospects for generic competition. However, brand loyalty and clinical familiarity sustain the current market dominance.

How Do Competitive Products and Pipeline Developments Affect the Market?

Emerging agents, such as the CXCR4 antagonist motixafor, are progressing through clinical trials with promising mobilization efficacy. If approved, they could challenge plerixafor’s market share, especially if priced lower or demonstrating superior safety profiles.

Other pipeline candidates include agents targeting alternative pathways for stem cell mobilization. The market expects to incorporate these competitors over the next 3-5 years, potentially suppressing growth rates of existing drugs.

What Are the Regional Variations in Market Dynamics?

North America: Market leader driven by established healthcare infrastructure, high adoption rates, and reimbursement pathways.

Europe: Growing demand supported by expanding transplant programs; regulatory approval delays in some countries affect timing.

Asia-Pacific: Rapid growth due to increasing cancer prevalence, improving healthcare infrastructure, and government initiatives to expand access to advanced therapies.

Latin America and Middle East: Market also expanding but constrained by cost and regulatory challenges.

Summary of Financial and Market Indicators

Metric	Data
2022 Global Market Value	$720 million
Plerixafor Revenue (2022)	$432 million
Estimated CAGR (2023-2028)	12.3%
2026 Revenue Projection	Over $800 million
Regional Market Share (2022)	North America 55%, Europe 30%
Price per Dose	$10,000–$15,000
Patent Expiration (approximate)	2026–2028 in major markets

Key Takeaways

• Plerixafor maintains a dominant position in hematopoietic stem cell mobilization, with consistent growth fueled by clinical adoption and expanding indications.
• The market faces potential disruptions from biosimilars and novel agents, notably in the coming three years.
• High treatment costs and reimbursement hurdles hinder broader access but do not significantly impede sales among established transplant centers.
• Regional growth varies, with Asia-Pacific emerging as a significant growth driver.
• Future market dynamics depend on clinical trial outcomes for pipeline agents and regulatory developments.

FAQs

1. What are the main drivers fueling plerixafor sales?
Increased use in stem cell mobilization protocols for multiple myeloma and lymphoma, along with expanding indications and rising cancer incidence globally.

2. How does the cost of plerixafor affect its market?
High per-dose costs limit adoption in some regions or institutions, especially where reimbursement is restricted.

3. What competitors threaten plerixafor in the market?
Emerging agents like motixafor and potential biosimilars could challenge its market share.

4. How will patent expirations impact sales?
Expiration may lead to generic entry, reducing prices and revenue but potentially increasing volume due to lower costs.

5. Which regions show the fastest growth in plerixafor usage?
Asia-Pacific regions exhibit the highest growth rates, driven by rising cancer rates and better healthcare access.

---

References

[1] MarketsandMarkets. (2023). Hematopoietic Stem Cell Mobilization Market.
[2] ClinicalTrials.gov. (2022). Plerixafor in Stem Cell Mobilization.
[3] Johnson & Johnson Annual Report. (2022). Plerixafor Sales and Pipeline Overview.