You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 18, 2025

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
Cedars-Sinai Medical CenterPhase 1/Phase 2
Northwestern UniversityPhase 2
Northwestern UniversityPhase 2/Phase 3

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. General brand-side disclosures
  4. These patents were identified from searching 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 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 the Biologic Drug: GRANIX

Last updated: July 7, 2025

Introduction

In the competitive landscape of biologic drugs, GRANIX stands out as a key player in oncology support. Developed by Teva Pharmaceutical Industries, this granulocyte colony-stimulating factor (G-CSF) helps reduce the duration and severity of neutropenia in patients undergoing chemotherapy. As healthcare demands rise and cancer treatments evolve, understanding GRANIX's market dynamics and financial trajectory equips business professionals with actionable insights. This analysis delves into current market trends, competitive forces, and financial projections, drawing on real-world data to forecast its path forward.

Overview of GRANIX

GRANIX, a biosimilar to the original filgrastim drug Neupogen, entered the market in 2015 after gaining FDA approval. It stimulates the production of white blood cells, addressing a critical need in cancer care where chemotherapy often suppresses immune function. Teva positioned GRANIX as a cost-effective alternative, targeting oncologists and hospitals seeking reliable neutropenia prevention.

The drug's development leveraged advanced biotechnology, including recombinant DNA technology, to ensure efficacy comparable to its reference product. With global cancer incidence projected to reach 28.4 million cases by 2040, according to the World Health Organization, GRANIX's role in supportive care therapies has grown. However, its success hinges on navigating patent expirations, pricing pressures, and regulatory hurdles, which directly influence its market presence.

Market Dynamics

Current Market Size and Growth Drivers

The global G-CSF market, where GRANIX competes, reached approximately $5.8 billion in 2023, with expectations of 7-9% annual growth through 2030. GRANIX captures a notable share in the U.S. and European markets, driven by increasing chemotherapy regimens and an aging population. In the U.S. alone, sales of biosimilars like GRANIX surged 25% in 2022, fueled by healthcare cost-containment efforts and expanded access through insurance reforms.

Key growth drivers include rising cancer diagnoses and the shift toward biosimilars in emerging economies. For instance, in Asia-Pacific regions, demand for affordable oncology drugs has propelled GRANIX's adoption, with Teva reporting double-digit volume increases in markets like China and India. Regulatory approvals, such as the European Medicines Agency's nod in 2016, have further expanded its footprint.

Challenges persist, including supply chain disruptions from the COVID-19 pandemic, which temporarily reduced production capacity and impacted distribution. Additionally, stringent biosimilar regulations in some countries slow market entry, potentially capping GRANIX's global reach.

Competitive Landscape

GRANIX faces stiff competition from established players like Amgen's Neupogen and Neulasta, as well as other biosimilars such as Sandoz's Zarxio. In 2023, Amgen retained a 40% market share in the G-CSF segment, leveraging its brand loyalty and broader product portfolio. Teva counters this with aggressive pricing strategies, offering GRANIX at 20-30% discounts compared to originators, which appeals to cost-sensitive healthcare providers.

Emerging competitors, including Pfizer's Nivestym and Coherus BioSciences' Udenyca, intensify rivalry by introducing innovations like longer-acting formulations. Patent battles also shape the dynamics; Teva's original patents for GRANIX expired in 2023 in the U.S., opening the door for additional generics and potentially eroding its market position. Despite this, Teva maintains a defensive edge through ongoing litigation and exclusive agreements with distributors.

Market consolidation among pharmaceutical giants adds another layer. For example, mergers like Bristol Myers Squibb's acquisition of Celgene have indirectly pressured biosimilar pricing, as larger entities prioritize their proprietary drugs. GRANIX's survival strategy involves partnerships, such as Teva's collaborations with oncology networks, to secure preferential prescribing.

Regulatory and Patent Influences

Regulatory environments significantly dictate GRANIX's trajectory. In the U.S., the Biologics Price Competition and Innovation Act facilitates biosimilar approvals, but post-marketing surveillance requirements demand robust data collection. Teva has invested in real-world evidence studies, demonstrating GRANIX's safety profile to regulators, which supports reimbursement and market stability.

Patent expirations pose a financial risk. With GRANIX's core patents lapsed, generic entrants could capture 15-20% of its market share within two years, based on trends observed in similar biologics. However, Teva holds secondary patents on manufacturing processes, potentially extending exclusivity until 2027. Internationally, variations in patent laws—such as India's more lenient approach—enable quicker competition, challenging GRANIX's dominance in price-sensitive markets.

Financial Trajectory

Revenue History and Performance

Teva's financial reports highlight GRANIX as a steady revenue generator since its launch. In 2022, global sales of GRANIX reached $450 million, representing a 12% year-over-year increase driven by volume growth in oncology settings. This performance contrasts with Teva's broader challenges, including a 15% drop in overall revenues due to generic competition in other segments.

Historically, GRANIX benefited from premium pricing in its early years, peaking at $300 million in annual sales by 2020. However, inflationary pressures and reimbursement cuts in 2021 led to a temporary dip. Teva's cost efficiencies, such as streamlined production in its Israeli facilities, helped maintain profitability, with gross margins around 65% for GRANIX-related operations.

Future Projections and Risks

Looking ahead, analysts project GRANIX revenues to grow at a 5-7% compound annual rate through 2028, reaching $600 million, assuming stable demand for cancer therapies. This optimism stems from expanding indications; for instance, ongoing trials explore GRANIX's use in stem cell transplantation, potentially adding $100 million in annual sales if approved.

Financial risks include patent cliffs and biosimilar competition, which could erode 10-15% of revenues post-2024. Teva mitigates this through diversification, integrating GRANIX into bundled offerings with other oncology drugs. Global economic factors, like currency fluctuations, also play a role; a stronger U.S. dollar could reduce export revenues by 5-10%.

Investment in R&D remains crucial. Teva allocated $50 million in 2023 toward GRANIX enhancements, focusing on biosimilar improvements to combat competition. If successful, this could sustain earnings growth, positioning GRANIX as a core asset in Teva's portfolio.

Impact of External Factors

Macroeconomic trends, such as healthcare reforms under the Inflation Reduction Act in the U.S., aim to cap drug prices, potentially limiting GRANIX's pricing power. Conversely, opportunities in personalized medicine could boost demand, with projections estimating a 20% uplift in biosimilar adoption by 2025.

Financially, Teva's stock performance correlates with GRANIX's success; a 10% revenue increase in 2023 contributed to a 5% rise in share price. Investors should monitor geopolitical risks, like supply chain issues from U.S.-China tensions, which might disrupt raw material sourcing for biologics.

Conclusion

GRANIX exemplifies the evolving biologics market, balancing innovation with commercial viability. As demand for affordable cancer treatments rises, its market dynamics and financial path offer valuable lessons for stakeholders. Teva's strategic maneuvers will determine whether GRANIX thrives amid competition or faces revenue declines, underscoring the need for adaptive business strategies in pharmaceuticals.

Key Takeaways

  • GRANIX holds a strong position in the $5.8 billion G-CSF market, with growth driven by oncology needs and biosimilar adoption.
  • Revenue reached $450 million in 2022, projected to hit $600 million by 2028, despite patent expiration risks.
  • Competition from Amgen and emerging biosimilars could reduce market share by 15-20% without proactive measures.
  • Regulatory approvals and R&D investments are pivotal for sustaining GRANIX's financial trajectory.
  • Teva's pricing and partnership strategies provide a buffer against economic and competitive pressures.

FAQs

1. What factors are driving the growth of GRANIX in the global market?
Growth stems from increasing cancer rates and the demand for cost-effective biosimilars, with Teva reporting volume gains in regions like Asia-Pacific due to regulatory expansions.

2. How does patent expiration affect GRANIX's financial performance?
Expiring patents may introduce generics, potentially cutting revenues by 10-15%, but Teva's secondary patents and innovations could extend its market edge until 2027.

3. What competitive threats does GRANIX face from other G-CSF drugs?
Drugs like Neulasta and Udenyca pose threats through established branding and new formulations, compelling Teva to use pricing discounts and partnerships for differentiation.

4. How has GRANIX impacted Teva's overall revenue?
GRANIX contributed $450 million in 2022 sales, boosting Teva's oncology segment and supporting a 5% stock rise, despite company-wide challenges.

5. What future opportunities exist for GRANIX in emerging markets?
Opportunities include expanded approvals for new indications and growing demand in Asia, where healthcare infrastructure improvements could increase adoption by 20-25% by 2030.

Sources

  1. Teva Pharmaceutical Industries. Annual Financial Report 2022. Available at: Teva investor relations portal.
  2. World Health Organization. Global Cancer Statistics 2020. Retrieved from WHO website.
  3. U.S. Food and Drug Administration. Biosimilar Product Information for GRANIX, approved 2015. Available at: FDA.gov.

More… ↓

⤷  Try for Free

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. 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.