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:	5,166
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	RE42152
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	6,987,102

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
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	C300537	Netherlands		PRODUCT NAME: PLERIXAFOR IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	CA 2012 00026	Denmark		PRODUCT NAME: PLERIXAFOR I ALLE FORMER SOM BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/01/09/537/001 20090804
1411918	PA2012011	Lithuania		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	92033	Luxembourg		92033, EXPIRES: 20240731
1411918	122012000044	Germany		PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER EIN METALLKOMPLEX DAVON; 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: June 17, 2026

Mozobil (plerixafor): Market dynamics, pricing trajectory, and financial performance

Mozobil (plerixafor injection) is a niche oncology-adjunct product in the stem cell mobilization setting. Commercial performance is structurally constrained by (i) a limited addressable population relative to large blockbuster markets, (ii) competitive alternatives within mobilization regimens, and (iii) tendering and reimbursement pressure in specialized transplant centers. Financial trajectory is also shaped by the product’s post-launch lifecycle position: patent and exclusivity windows determine the timing and aggressiveness of generic or biosimilar-adjacent competitive entry, while FDA labeling and REMS-free status influence payer adoption rather than safety-driven restrictions.

Core market mechanics (what drives monthly/annual revenue movement)

Mozobil revenue tracks patient volumes for autologous stem cell transplant (ASCT) mobilization plus how often it is added to G-CSF-based mobilization failure or insufficient-mobilization pathways. In practice, uptake is highest in centers that use Mozobil as a standardized “rescue” or “add-on” component rather than a first-line mobilization for all patients.

Key commercial levers:

• Transplant throughput and conditioning protocols: More ASCT procedures and more consistent mobilization algorithm adherence increase demand.
• Center preference and formulary access: Krankenhaus and US hospital pharmacy contracting can shift usage across G-CSF strategies, affecting plerixafor mix.
• Wholesale acquisition cost and net price compression: Specialty drug discounting, 340B effects in eligible providers, and group purchasing organization pricing can depress net revenue even if list price remains stable.
• Competitive substitution risk: If alternative mobilizers or regimen optimizations deliver comparable collection outcomes, prescribers reduce use of Mozobil in marginal cases.

Financial trajectory drivers (what moves income statements)

Financial outcomes depend less on broad market expansion and more on:

• Volume durability: Whether transplant programs maintain plerixafor use in their mobilization standard operating procedures.
• Price erosion: Net price declines from tendering and rebate structures.
• Manufacturing and supply continuity: Specialty injectable availability issues can cause short-term revenue discontinuities.
• Lifecycle risk: Patent-expiration calendar and generic entry scenarios drive step-function revenue changes around the exclusivity cliff.

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How does Mozobil (plerixafor) perform commercially in the stem cell mobilization market?

Short answer: Mozobil revenue is driven by the number of ASCT mobilization attempts where plerixafor is used, primarily as add-on therapy to improve collection yield. The market is specialized and tends to show slower growth than broad oncology drugs.

Where Mozobil fits in clinical practice

Mozobil is used for stem cell mobilization and is typically positioned in pathways that aim to improve CD34+ collection adequacy. Its commercial value concentrates in:

• Patients with suboptimal mobilization on G-CSF
• Programs adopting rescue mobilization protocols
• Centers seeking predictable collection performance to avoid delays in transplant schedules

Demand volatility patterns

Revenue is sensitive to:

• Quarterly transplant schedules
• Policy-driven mobilization algorithms (protocol updates can shift use rates quickly)
• Payer authorization and budget caps for high-cost injectables

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What pricing and net revenue trajectory has Mozobil followed since launch?

Short answer: Mozobil’s economic trajectory in mature markets generally reflects list price stability with net price pressure from contracting and payer discounts, rather than large periodic price jumps.

Typical specialty drug pricing structure (US)

Mozobil pricing outcomes are often determined by:

• WAC-to-net spreads governed by rebates and hospital purchasing discounts
• Specialty distribution terms through wholesalers, affecting fill-in timing
• Center-by-center formulary placement: even small changes in access can impact volume share

Market outcome expectation

In the absence of broad category growth, revenue movement typically comes from:

• mix shift between patient categories (rescues versus routine use),
• payer and contracting renegotiation cycles,
• and lifecycle competition that increases price pressure.

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When does Mozobil lose exclusivity, and how does that affect revenue risk?

Short answer: Revenue risk rises at the exclusivity cliff, when generic entry pressure can force margin compression. The timing depends on patent expiration and any applicable exclusivity protections tied to FDA approvals.

Exclusivity vs. patent expiration: what matters for revenue

For products like Mozobil, the key financial inflection points are:

• Patent expiration date(s) that permit generic manufacturing and FDA ANDA submission depending on the regulatory status.
• Any data exclusivity that blocks approvals even if patents have lapsed.
• Design-around and delayed generic launch outcomes, which can extend revenue beyond the first available entry date.

Generic launch scenario mechanics

If entry occurs:

• Net price compression usually starts before full erosion as payers renegotiate.
• Volume migration can be rapid in institutional formularies.
• Short-term revenue may hold if alternative products face supply constraints, but the longer-run pattern is downward.

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What patents protect plerixafor (Mozobil) and how strong is the patent estate?

Short answer: Mozobil’s patent estate governs entry timing and the pace of market erosion. The practical “strength” for financial planning is measured by (i) number of unexpired claims, (ii) coverage breadth (formulation, method of use, process), and (iii) litigation history.

Patent estate categories that affect market outcomes

• Composition and formulation patents: block identical product launch and sometimes cover manufacturing formulation details.
• Method-of-use patents: can affect label carve-outs and how generics can be marketed.
• Process/manufacturing patents: can delay supply if generic manufacturing must be redesigned.
• Device/delivery (if applicable): can affect ability to deliver identical product presentation.

Financial relevance of estate density

A dense estate across multiple jurisdictions increases:

• entry friction,
• settlement leverage,
• and the odds of “authorized generic” or delayed launches.

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Has Mozobil faced Paragraph IV challenges or patent litigation that changed its commercial outlook?

Short answer: Patent litigation can create step-function shifts in revenue expectations due to settlement-driven “launch calendars,” even when clinical demand remains stable.

What to track for revenue impact

• ANDA filing timing and whether it includes paragraph IV certifications.
• Injunction outcomes that can stop or delay launch.
• Settlement agreements that set specific launch dates or stipulate payment/royalty terms.

Litigation-driven market dynamics

Even without a definitive settlement:

• the presence of active litigation can deter aggressive procurement by some buyers until entry is clarified,
• and it can create interim pricing negotiations as players prepare for switching.

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What is the Orange Book status of Mozobil, and which listings matter for generic entry?

Short answer: Orange Book listings control whether an ANDA can rely on the reference listed drug and the unexpired patent landscape. Listings that expire later than others tend to dictate generic timelines.

What matters in Orange Book for business planning

• Drug substance and drug product patent expiration dates
• Method-of-use patent expiration (if the label includes protected instructions)
• Any exclusivity codes that can delay approval
• Submission dates and listed assignees that indicate who controls licensing and settlements

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What generic entry risks exist for Mozobil, and what launch scenarios should be modeled?

Short answer: The main financial risk is net price erosion after generic entry plus volume migration by transplant centers and hospital buyers.

Modelable entry scenarios

1. Early generic entry with narrow label
   Generic launches with restrictions that limit uptake, reducing volume share but still forcing price compression.
2. Full label substitution
   Faster uptake and larger revenue decline as formulary switches accelerate.
3. Authorized generic or pay-to-delay settlement
   Near-term price remains stabilized while competition is phased, but longer-run erosion still occurs.
4. Design-around that triggers slower uptake
   Clinical equivalence and payer acceptance determine whether switching is fast or incremental.

Financial indicators to monitor

• Wholesale inventory trends and discounting changes
• Hospital formulary updates
• Net-to-gross ratio shifts (rebates and discounts)
• Share-of-market trends in mobilization rescue populations

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How does Mozobil compare with alternative stem cell mobilization strategies?

Short answer: Mozobil’s competitive set is not only other drugs, but regimen strategies. Its value is collection performance, patient convenience, and avoiding transplant scheduling delays.

Competitive axes

• Clinical outcomes: CD34+ yield and days to collection
• Operational fit: infusion scheduling, monitoring, and mobilization workflow
• Payer coverage: prior authorization and budget impact in transplant centers
• Total cost of care: whether Mozobil reduces downstream costs from failed mobilization

Net effect on demand

If competing strategies reduce the proportion of patients requiring rescue, Mozobil’s addressable volume shrinks even if transplant numbers stay flat.

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What is the FDA regulatory status of Mozobil, and does it constrain commercialization?

Short answer: As a specialty injectable with an established regulatory footprint, Mozobil’s commercialization is more constrained by payer and lifecycle factors than by major regulatory operational barriers.

Commercial relevance of regulatory posture

• Label scope: determines clinical and reimbursement eligibility
• No procedural complexity beyond standard injectable handling: reduces adoption friction
• Manufacturing continuity: impacts fill rates and payer confidence

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Which companies market Mozobil, and how do ownership and manufacturing affect supply and pricing?

Short answer: The commercial trajectory reflects the manufacturer’s manufacturing scale, supply reliability, and contracting discipline.

What to examine for market dynamics

• Manufacturer and site capacity: supply disruptions create revenue volatility.
• Distribution agreements: can alter timing of shipments and recognized revenue.
• Contracting behavior: stronger payer relationships typically stabilize net price.

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Where does Mozobil sit in the transplant pipeline, and how do seasonal and protocol shifts change revenue?

Short answer: Demand aligns with transplant scheduling rather than a seasonal consumer pattern. Protocol changes can shift plerixafor use rates quickly.

Protocol drift factors

• Updated mobilization algorithms
• Evidence adoption from clinical studies and center experience
• Changes in G-CSF product usage and dosing practices
• Transplant volume cycles from broader oncology treatment patterns

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Key tables: what to model for revenue forecasting

Revenue driver map

Driver	Commercial effect	Forecast modeling impact
ASCT mobilization volume	Core demand	High weight
Rescue-add-on usage rate	Mix shift	High weight
Net price (rebates, tendering)	Margin and revenue	High weight
Contract access changes	Sudden volume shifts	Medium-high
Supply continuity	Shipment timing	Medium
Patent and exclusivity cliff	Step-function entry risk	Critical
Litigation/settlement timing	Entry calendar	Critical

Lifecycle timeline framework (template)

Event type	What to plug in	Revenue effect window
Patent expiration	First date of potential ANDA approval readiness	Lead-in to erosion
Exclusivity end	Data exclusivity loss	Approval readiness step
Litigation resolution	Settlement or final ruling	Jump in entry probability
Generic launch	First commercial sales	Rapid price and share shift
Post-launch share stabilization	6-18 months after launch	Gradual erosion

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Key Takeaways

• Mozobil is a specialized, transplant-linked injectable whose revenue is primarily driven by plerixafor add-on and rescue utilization in stem cell mobilization workflows.
• Mature-market economics are dominated by net price compression from contracting and payer discounts, with smaller contribution from list price changes.
• The largest downside risk is lifecycle-driven: patent/exclusivity events and generic entry calendars can trigger sharp revenue declines through both volume migration and price erosion.
• Competitive pressure comes as much from regimen optimization as from direct product substitution, since center protocols determine the proportion of patients needing rescue plerixafor.

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FAQs

1) What patient populations drive Mozobil demand?

Mozobil demand is driven by ASCT mobilization patients where plerixafor is used to improve collection adequacy, especially those with suboptimal mobilization response.

2) Why can Mozobil revenue change even when transplant volume is stable?

Net pricing, formulary access changes, and rescue-use protocol adjustments can shift utilization rates and discounting independent of overall ASCT volumes.

3) How should a forecast incorporate generic entry risk for Mozobil?

Model step-function probability of erosion around patent/exclusivity endpoints, then simulate post-launch net price compression and volume migration based on payer and center switching behavior.

4) Does Mozobil face supply-chain risks that affect revenue timing?

As a specialty injectable, Mozobil can show quarterly shipment volatility if manufacturing or distribution disruptions occur, even if underlying demand stays constant.

5) What commercial metric best signals whether plerixafor utilization is increasing or declining?

Tracking institutional utilization rates by mobilization program segment, alongside net price and net-to-gross ratio trends, gives the clearest early signal.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drug Approval Reports and related regulatory information for plerixafor. https://www.accessdata.fda.gov/