Last Updated: June 23, 2026

GRANIX Drug Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Tradename: GRANIX
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for GRANIX
Recent Clinical Trials for GRANIX

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Massachusetts General HospitalPHASE2
Cedars-Sinai Medical CenterPhase 1/Phase 2
Northwestern UniversityPhase 2

See all GRANIX clinical trials

Pharmacology for GRANIX
Physiological EffectIncreased Myeloid Cell Production
Established Pharmacologic ClassLeukocyte Growth Factor
Chemical StructureGranulocyte Colony-Stimulating Factor
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for GRANIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GRANIX Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for GRANIX Derived from Patent Text Search

No patents found based on company disclosures

Market dynamics and financial trajectory for GRANIX (tbo-filgrastim)

Last updated: April 24, 2026

What is GRANIX’s market position and how has demand moved?

GRANIX (tbo-filgrastim), a biosimilar-in-class biologic (filgrastim/pegfilgrastim portfolio competitor), is used to reduce the incidence of chemotherapy-induced neutropenia. Market dynamics for this class are dominated by (1) oncology treatment volumes, (2) adoption of preferred growth-factor strategies in guidelines and payor formularies, (3) shifts between daily filgrastim-like regimens and longer-acting options, and (4) biosimilar and follow-on competition pressure.

Key demand drivers

  • Chemotherapy mix: Demand tracks active oncology drug usage, particularly regimens that trigger neutropenia risk categories.
  • Guideline and practice patterns: Growth factor use rises when prophylaxis is recommended by risk threshold and falls when practice shifts to dose modifications.
  • Duration economics: Daily short-acting products compete against longer-acting pegfilgrastim and biosimilars; payors steer to lower-cost-per-cycle options.
  • Institutional purchasing: Hospital group purchasing organizations and payer step edits shape channel velocity and contract terms.

What the market has done to branded economics The branded filgrastim segment has faced compression as follow-on products gained share and payors leaned on competitive pricing. For GRANIX specifically, the commercial profile shows a product that persists in the market, but under continued pricing pressure typical of mature supportive oncology biologics.

How has GRANIX performed financially in the public disclosures available?

Public financial reporting for tbo-filgrastim is constrained by how the owning company reports biosimilar-like supportive-care assets. In practice, performance is assessed through:

  • product-level revenue disclosures when available,
  • segment reporting where GRANIX is material,
  • and market trajectory inferred from contract dynamics and class-level competition.

Bottom-line trajectory pattern

  • GRANIX has remained commercially relevant, but its growth has generally been capped by class saturation and competitive substitution.
  • The product’s revenue performance has been shaped more by share and contracting than by category expansion, consistent with a mature supportive-care market.

What financial levers explain revenue stability or decline?

For daily G-CSF products like GRANIX, the revenue path typically depends on four levers:

  1. Net price and rebates

    • Biosimilar and follow-on entrants push list prices down and increase rebate intensity.
    • Institutional contracts can drive step-downs even when patient volumes hold steady.
  2. Dose and cycle utilization

    • Growth factor use follows clinical protocols (dose number per cycle, timing rules, and outpatient versus inpatient administration).
    • Tightening of prophylaxis indications reduces cycle-level utilization.
  3. Switching between agents

    • Providers may switch to longer-acting alternatives when logistics and payer coverage favor them.
    • Switching can occur even without clinical superiority if the formulary and administration burden tip.
  4. Geography and payer mix

    • Markets with competitive tendering show faster price erosion.
    • Payer mix changes can shift the reimbursement economics quickly.

How does competitive pressure shape GRANIX’s trading and forecast posture?

GRANIX competes within the G-CSF family that includes filgrastim products and longer-acting pegfilgrastim (and their biosimilars). This competitive set matters because payors manage to the “lowest acquisition cost per appropriately treated patient/cycle,” often favoring:

  • longer-acting agents to reduce administration visits (site-of-care cost),
  • biosimilars when available,
  • and contract-specific preferred agents.

Implication for financial trajectory A product like GRANIX tends to show:

  • stable baseline utilization in patients/care settings where daily dosing is operationally preferred or covered,
  • but headwinds as payor formularies rationalize across G-CSF alternatives.

What regulatory and lifecycle facts matter to market dynamics?

GRANIX is a biologic that has completed initial development and is now in mature lifecycle. Market dynamics remain influenced by:

  • label breadth and oncology indications already established,
  • manufacturing supply stability (important for biologics),
  • and the pace of competitive entrants within the same class.

Clinical and safety relevance The product is positioned for prevention/reduction of chemotherapy-induced neutropenia, meaning adoption ties to chemotherapy schedules and guideline prophylaxis thresholds rather than to new clinical paradigms.

How does biosimilar and follow-on competition typically impact the category’s price curve?

In supportive oncology biologics, the pricing curve usually follows:

  • early market uptake with relatively higher net pricing,
  • then a period of net price compression as alternatives enter,
  • followed by margin pressure due to tendering and rebate pressure.

For daily G-CSF offerings, this often results in:

  • slower revenue growth or net revenue decline after peak,
  • lower willingness among payors to pay premium pricing for non-preferred daily regimens when preferred agents exist.

What is the likely financial trajectory shape for GRANIX under current dynamics?

Given category maturity and typical competitive dynamics for daily G-CSF products, the expected trajectory is:

  • Revenue plateau with gradual erosion driven by net price pressure,
  • Volatility tied to contract renewals and formulary status at large institutions and payors,
  • Share changes primarily due to procurement rules rather than clinical repositioning.

Key takeaways

  • GRANIX’s market dynamics are dominated by chemotherapy volumes, guideline prophylaxis patterns, and payer/institution procurement across the G-CSF class.
  • The financial trajectory for a mature daily filgrastim-like biologic is typically revenue stabilization with pricing-driven erosion, shaped by contracting, rebates, and substitution to preferred agents.
  • Competitive pressure from filgrastim and pegfilgrastim biosimilar/follow-on options is the main economic driver for GRANIX’s net revenue outlook.

FAQs

1) What drives GRANIX demand the most?
Chemotherapy cycles that meet prophylaxis thresholds under oncology guidelines, combined with payor and hospital coverage of the daily G-CSF regimen.

2) Why does daily dosing matter economically?
Daily dosing impacts site workflow and treatment logistics. Payors often favor longer-acting options when total cost per treated cycle is lower.

3) How do formulary decisions affect GRANIX revenue?
Preferred-agent placement and contract pricing drive patient routing and outpatient/inpatient administration patterns, shifting share without requiring new clinical entrants.

4) What kind of revenue trend does this category usually show?
A plateauing baseline with net price compression over time as competition and biosimilar substitution increase.

5) What is the biggest commercial risk to GRANIX?
Losing preferred status in payer and institutional contracts to longer-acting or lower net-cost alternatives in the G-CSF portfolio.


References

[1] U.S. Food and Drug Administration. “GRANIX (tbo-filgrastim) Prescribing Information.” FDA label.
[2] World Health Organization. “Neutropenia and G-CSF use in chemotherapy supportive care” (general supportive care guidance).
[3] National Comprehensive Cancer Network (NCCN). “Management of Myeloid Growth Factors” (guideline section covering G-CSF prophylaxis use).

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.