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. Thirteen 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:	13
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	166
Patent Applications:	7,831
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
Zydus Pharms	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	208980-001	Jul 26, 2023		DISCN	No	No
Hetero Labs Ltd Vi	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	217560-001	Jun 16, 2025	AP	RX	No	No
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	AP	RX	Yes	Yes
Eugia Pharma	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	213672-001	Jul 24, 2023	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	7,897,590
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	RE42152
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	6,987,102

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

Plerixafor Market Dynamics and Financial Trajectory (Revenue, Growth Drivers, Exclusivity Timeline, and Competitive Risk)

Last updated: July 25, 2026

Plerixafor (trade name Mozobil; active ingredient plerixafor) targets mobilization of hematopoietic stem/progenitor cells in adults with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) undergoing autologous stem cell transplantation (ASCT). The commercial trajectory is constrained by a limited addressable population, formulation and method-of-use patent layering, and competitive pressure from mobilization regimens that rely on G-CSF alone. Financial outcomes are also sensitive to transplant volumes and payer design of mobilization pathways.

What is the commercial profile of PLERIXAFOR (Mozobil) and how has revenue evolved?

Plerixafor is marketed in the US under Mozobil by Genzyme/ Sanofi historical brand structure, with later commercialization economics shaped by transplant volumes, transplant-center protocols, and payer contracting.

Core demand driver

• Use-case is narrow: mobilization in ASCT settings for NHL and MM after inadequate response to G-CSF-based mobilization or as part of specified mobilization strategies consistent with labeling.

Primary commercial friction

• Limited patient pool: only a subset of ASCT candidates need or use plerixafor.
• Substitutability at the regimen level: many patients reach adequate mobilization with G-CSF alone, reducing plerixafor uptake.
• Site-of-care cost sensitivity: mobilization choices affect total per-transplant episode cost.

Featured-snippet answer

• Plerixafor behaves as an “add-on” mobilization product inside ASCT workflows rather than a broad oncology blockbuster. Revenue trajectory tracks transplant volumes and the share of patients classified as mobilization failures or high-risk for poor collection.

How do hematopoietic stem cell mobilization protocols drive PLERIXAFOR volume and uptake?

Plerixafor adoption is protocol-dependent. Most centers start with G-CSF. Plerixafor is then used to “rescue” or enhance collection when CD34+ yields underperform.

Protocol-based variables that move sales

• Baseline G-CSF mobilization success rate at the center
• Use of plerixafor as preemptive “front-loading” versus true rescue after early collection metrics
• Center thresholds for proceeding to apheresis and changing mobilization strategy
• Institutional payer formularies and step-therapy policies

Utilization channel dynamics

• Sales skew to large transplant centers and established ASCT programs with standardized mobilization pathways.
• Demand is more sensitive to apheresis scheduling and lab turnaround (CD34+ monitoring) than to patient-level persistence.

What is the payer and reimbursement logic for PLERIXAFOR in ASCT care pathways?

Payers tend to evaluate plerixafor as a high-cost supportive oncology medication. Coverage and reimbursement often hinge on:

• Documentation of inadequate response to prior mobilization (for rescue use).
• Eligibility consistent with the FDA label indications.
• Hospital or specialty pharmacy contracting and drug acquisition channel.

Economic mechanism

• Plerixafor may be reimbursed as part of the transplant episode cost model, which pressures centers to avoid rework and delays.
• If early mobilization failure increases downstream costs (repeat mobilization, failed harvest), plerixafor gains economic leverage.

Featured-snippet answer

• Plerixafor’s reimbursement is typically justified through a “collection success” economics model inside transplant pathway management, not through chronic use.

When does PLERIXAFOR lose exclusivity and what does that mean for generic or biosimilar risk?

Plerixafor is a small-molecule drug (chemically synthesized antagonist of CXCR4). That profile generally supports generic pathways under the Hatch-Waxman framework rather than biosimilar risk.

Exclusivity concepts relevant to a small molecule

• Composition patents: protect the active ingredient and/or specific solid forms
• Method-of-use patents: protect mobilization regimens and transplant-related indications
• Formulation patents: protect delivery forms and stability/processing

Impact of exclusivity expiry

• Once key Orange Book-listed patents expire, generic manufacturers can pursue ANDA.
• If unexpired method-of-use patents remain, Paragraph IV certifications must address them case-by-case, with litigation risk delaying launch.

Featured-snippet answer

• Generic entry risk is primarily driven by Orange Book patent expiry and litigation posture, not by biosimilar dynamics.

What patents protect PLERIXAFOR (Mozobil) and how dense is the estate?

A complete patent-strength and timeline analysis requires Orange Book listings tied to the specific FDA application reference listed drug. The market dynamics and litigation outcomes for plerixafor depend on:

• Number of Orange Book patents per category (drug substance, drug product, method)
• Staggered expirations for different claim sets
• Whether method-of-use patents survive composition or formulation expiry

Patent layering that typically matters for Mozobil

• Drug substance and solid-state/chemical composition coverage
• Drug product/formulation (tablet/solution and stability) claims
• Method-of-use claims tied to mobilization dosing, timing, or patient selection

Featured-snippet answer

• For plerixafor, method-of-use patent survival usually determines whether generics can enter for the same labeled mobilization strategy even after earlier composition expiry.

What is the Orange Book status of PLERIXAFOR (Mozobil) and which ANDA pathways are plausible?

Orange Book status governs the practical launch timeline for generic plerixafor because it lists patents that an ANDA filer must certify to. The key market question is:

• Which patents are still listed and active
• Whether any have been challenged through Paragraph IV

Generic pathway logic

• If an ANDA filer can certify to “not infringed” or “invalid” for at least one listed patent and succeeds or settles, it can launch at the relevant effective date.
• If patents remain active with strong infringement positions, launch can be deferred via litigation or settlement.

Featured-snippet answer

• ANDA launch timing is a function of Orange Book patent expiry date sequencing and any Paragraph IV challenge/settlement outcomes.

How does PLERIXAFOR compare with competing mobilization regimens for ASCT?

The main competitive set is not a single branded drug but mobilization strategies:

• G-CSF alone (cheaper, commonly successful for many patients)
• G-CSF plus different mobilization adjunct strategies used in practice
• Plerixafor rescue versus preemptive use
• Center-specific collection and processing workflows

Competitive advantage mechanisms for plerixafor

• Improves likelihood of adequate CD34+ cell collection in poor mobilizers
• Reduces risk of collection failure and repeat mobilizations
• Fits into time-sensitive apheresis schedules once decision thresholds are met

Featured-snippet answer

• Plerixafor competes against the share of transplant candidates who can achieve adequate mobilization without it.

What patent litigation or settlement activity affects PLERIXAFOR generic entry risk?

Generic launch risk in the US depends on:

• Whether ANDA filers have asserted Paragraph IV challenges
• Whether courts or settlement agreements resolve key patent disputes
• Whether settlements trigger “carve-outs” that delay generic availability

Featured-snippet answer

• The litigation record, not just patent expiry dates, determines real-world generic entry pacing.

How do dosing, administration, and patient selection influence market access and profitability?

Plerixafor is typically administered via injection in a transplant workflow tied to mobilization timing. Market profitability depends on:

• Dose frequency and duration in labeled pathways
• Patient selection criteria (poor mobilizers, high-risk collections)
• Operational ease for transplant centers (availability, cold-chain requirements, specialty pharmacy logistics)

Commercial leverage

• If centers can reduce failed harvests and repeat procedures, they adopt plerixafor more consistently.
• If payer authorization delays occur, uptake can slow even when clinical criteria are met.

What financial trajectory variables matter most for plerixafor beyond patent expiry?

Even with patent expiry, plerixafor’s financial trajectory can be shaped by:

• Transplant volume trends (ASCT demand correlates with hematologic cancer incidence and practice patterns)
• Adoption shifts in mobilization protocols (rescue versus preemptive)
• Channel dynamics (specialty pharmacy distribution share and hospital buy-sell agreements)
• Pricing pressure from payer contracting and competitive reference products at the regimen level

Featured-snippet answer

• Real revenue moves more on transplant demand and mobilization protocol share than on day-to-day competitive pricing within the plerixafor drug class.

What geographic and regulatory factors influence global commercialization and revenue?

Plerixafor’s market is primarily assessed by:

• US FDA label coverage (most important for US revenue trajectory)
• EU national reimbursement coverage and hospital formulary access
• Cross-border transplant practice heterogeneity

Regulatory pathway implications

• Tight indication definitions in the label can limit off-label expansion (and off-label adoption can be payer-restricted).
• Any label changes tied to patient subsets can shift volume.

Featured-snippet answer

• Global revenue depends on how reimbursement authorities define “inadequate mobilization” and whether they reimburse plerixafor as rescue or routinely for high-risk patients.

Key Takeaways

• Plerixafor (Mozobil) functions as an add-on mobilization product within ASCT workflows; its revenue trajectory tracks transplant volumes and the share of patients needing rescue-enhanced CD34+ collection.
• Market uptake is protocol-driven: center success rates with G-CSF alone materially affect plerixafor use.
• Generic entry risk is governed by Orange Book patent layering, especially method-of-use patents tied to mobilization dosing and patient selection; biosimilar risk is not applicable because plerixafor is a small molecule.
• Litigation and settlement events, not only patent expiry dates, determine US launch timing and the pace of pricing erosion.
• Financial trajectory is sensitive to payer authorization, specialty distribution dynamics, and collection-workflow economics that influence whether centers treat mobilization as a “preemptive” or “rescue” decision.

FAQs

1) How is plerixafor used in poor mobilizer rescue versus preemptive collection enhancement?
It is used to increase the probability of adequate CD34+ stem cell collection when initial mobilization with G-CSF is insufficient or when protocols identify high-risk collection outcomes.

2) Can generic plerixafor launch before all Orange Book patents expire?
Potentially, if an ANDA filer successfully challenges one or more listed patents through the statutory certification process and litigation or settlement permits entry at the relevant effective date.

3) What makes plerixafor different commercially from chronic oncology drugs?
Its use is episodic and tied to specific ASCT mobilization episodes rather than long-term continuous therapy.

4) What reimbursement features most affect plerixafor adoption at transplant centers?
Coverage criteria for rescue or mobilization-failure documentation, prior authorization processes, and how payers model per-transplant episode economics influence prescribing.

5) What are the main competitive threats to plerixafor revenue?
Competition comes from protocols that achieve adequate mobilization with G-CSF alone, from pathway redesign that reduces rescue rates, and from generic substitution after patent and litigation resolution.

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. FDA. Mozobil (plerixafor) prescribing information. US Food and Drug Administration, label document.