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Last Updated: March 19, 2026

PLERIXAFOR Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Plerixafor

A generic version of PLERIXAFOR was approved as plerixafor by AMNEAL on July 24th, 2023.

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Summary for PLERIXAFOR
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
Amneal PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 215334-001 Jul 24, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Msn PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 211901-001 Jul 24, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Gland PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 206644-001 May 3, 2024 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Pharms Usa Inc PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 205197-001 Jul 24, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Dr Reddys PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 205182-001 Jul 24, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Eugia Pharma PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 213672-001 Jul 24, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PLERIXAFOR Market Analysis and Financial Projection

Last updated: February 9, 2026

What Is the Market and Investment Potential for Plerixafor?

Plerixafor, marketed as Mozobil, is a CXCR4 receptor antagonist developed and commercialized primarily for hematopoietic stem cell mobilization in patients undergoing autologous stem cell transplantation. The drug generated revenue through partnerships and licensing agreements. The global market for stem cell mobilization agents was valued at approximately $2.8 billion in 2022. Plerixafor's commercial success is contingent on its therapeutic positioning, competition, and pipeline developments.

How Does Plerixafor Fit Within the Hematopoietic Stem Cell Mobilization Market?

Plerixafor addresses a niche in mobilization agents, competing mainly with granulocyte-colony stimulating factor (G-CSF) and other mobilizers under investigation like AMD3100 (the same molecule marketed as Mozobil). The drug is recommended for multiple myeloma and non-Hodgkin lymphoma patients who have inadequate mobilization with G-CSF alone.

The drug's sales peaked in 2020 at roughly $166 million globally, primarily in the U.S., with growth driven by approvals in expanded indications and increasing adoption. Sales declined afterward due to patent expirations and increased generic competition.

What Are the Core Fundamentals and Risks for Plerixafor?

Revenue Drivers

  • Indication Expansion: Plerixafor expanded into multiple myeloma and lymphoma indications, boosting market penetration.
  • Market Penetration: Adoption depends on clinicians' preference for mobilization protocols, with ongoing education influencing uptake.
  • Pricing and Reimbursement: High-cost pricing coupled with insurance coverage influences revenue; reimbursement issues can limit sales in certain markets.

Patent and Competition Landscape

  • Patent Status: The original patents expired in key markets by 2017, leading to generic competition that reduced revenue.
  • Pipeline & Competitors: New mobilization agents, including experimental drugs targeting alternative pathways, threaten market share. Biotech firms are exploring agents like motixafortide (POL6326), with Phase 2 data indicating potent mobilization capabilities.

Regulatory Environment

  • Approvals: Plerixafor was approved by FDA (2008) and EMA (2009). Future approvals for new uses could expand sales.
  • Orphan Drug Designation: No current orphan status, limiting exclusivity incentives.

Manufacturing & Supply Chain

  • Production Complexity: The drug's synthesis involves complex chemistry, influencing manufacturing costs.
  • Supply Stability: Limited suppliers pose risk to supply chain stability.

Financial Considerations

  • Revenue decline post-2020 due to patent loss. Revenue from earlier licensing deals (e.g., with Genzyme) contributed to early-stage cash flow.
  • Investment in pipeline compounds and new formulations can influence long-term value.

What Are the Future Growth Opportunities and Challenges?

Opportunities

  • Developing next-generation mobilization agents with better efficacy or fewer side effects.
  • Expanding indications into other transplant-related or hematological conditions.
  • Improving manufacturing efficiencies and reducing costs.

Challenges

  • Entry of low-cost generics undermines price control.
  • Competition from novel mobilization agents that demonstrate superior efficacy.
  • Slow adoption in certain clinical practices and geographical markets.

How Do the Fundamentals Compare with Alternative Therapies?

Factor Plerixafor G-CSF New Agents (e.g., motixafortide)
Market Size (2022) ~$2.8 billion Larger, estimated at $5 billion Still emerging
Patent Duration Expired by 2017 Patent protected until late 2020s Early-stage development
Efficacy in Mobilization High for difficult mobilizers Standard for many patients Potentially higher or faster
Cost High, driven by brand status Lower due to generics Yet to be fully commercialized

Summary & Investment Outlook

Plerixafor faces declining revenue due to patent expiry and competition from generics. However, ongoing development of second-generation agents and pipeline expansion in hematological indications can offer a long-term lift. Current valuation may be undervalued given its established clinical role and potential future approvals.

Investors should monitor pipeline progress, new competitor entry, and evolving reimbursement policies. Strategic licensing arrangements and alliances remain key for accessing broader markets.

Key Takeaways

  • Plerixafor's revenue peaked pre-2020, with decline following patent expiration.
  • Market growth hinges on indication expansion and adoption of new, more effective mobilizers.
  • Competition from generics and emerging agents pressures pricing and margins.
  • Future value depends on pipeline success, including new mobilization agents and expanded indications.
  • Manufacturing complexities and supply risks influence supply chain stability.

FAQs

Q1: What are the primary indications for plerixafor?
Hematopoietic stem cell mobilization in patients with multiple myeloma or non-Hodgkin lymphoma, mainly as an adjunct in cases of poor mobilization with G-CSF alone.

Q2: How significant is patent expiry for plerixafor?
Major patents expired in markets like the U.S. in 2017, leading to increased generic competition and a decline in brand revenue.

Q3: What are the main competitive threats?
Emerging mobilization agents such as motixafortide, and biosimilar G-CSF products, threaten market share and pricing power.

Q4: Are there regulatory opportunities for plerixafor?
Yes. Expanding indications or obtaining orphan drug status for niche hematologic disorders could extend market exclusivity or open new revenue streams.

Q5: What is the outlook for pipeline products targeting stem cell mobilization?
Multiple agents are in development stages, with some demonstrating superior efficacy in early trials, suggesting potential for market disruption.


Sources:
[1] Global Hematopoietic Stem Cell Mobilization Market Reports, 2022
[2] FDA & EMA Approval Announcements for Plerixafor
[3] Industry Patent Databases, 2023
[4] Competitive Landscape Analyses, 2023

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