GAZYVA Drug Profile

Summary for Tradename: GAZYVA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for GAZYVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GAZYVA

Recent Clinical Trials for GAZYVA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
City of Hope Medical Center	Phase 2
Bristol-Myers Squibb	Phase 2
Incyte Corporation	Phase 1

See all GAZYVA clinical trials

Recent Litigation for GAZYVA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Acerta Pharma B.V. v. Cipla Limited	2024-05-16
Acerta Pharma B.V. v. Sandoz Inc.	2022-02-04
Acerta Pharma B.V. v. Cipla Limited	2022-02-03

See all GAZYVA litigation

PTAB Litigation

Petitioner	Date
Sandoz Inc.	2023-02-03

See all GAZYVA litigation

Pharmacology for GAZYVA

Mechanism of Action	CD20-directed Antibody Interactions
Established Pharmacologic Class	CD20-directed Cytolytic Antibody

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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 GAZYVA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GAZYVA Derived from Company Disclosures

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2034-01-08	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2034-02-21	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2035-12-02	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2036-06-30	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2035-02-04	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2033-03-12	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2035-10-05	Patent claims search

GAZYVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GAZYVA (Obinutuzumab)

Introduction

GAZYVA (obinutuzumab) is a monoclonal antibody developed by Roche, primarily used in the treatment of chronic lymphocytic leukemia (CLL) and other hematological malignancies. This article delves into the market dynamics and financial trajectory of GAZYVA, highlighting its regulatory milestones, market performance, and future outlook.

Regulatory Milestones

GAZYVA received FDA approval for the treatment of CLL in 2013, marking a significant milestone in its regulatory journey. Subsequent approvals have expanded its indications, including the use in combination with chemotherapy for previously untreated CLL patients. In 2014, the FDA approved a supplemental license application based on new study data showing improved outcomes for patients treated with GAZYVA plus chemotherapy compared to those treated with Rituxan and chemotherapy[1].

Market Performance

GAZYVA has shown promising market performance, particularly in the CLL treatment space. The drug has demonstrated superior efficacy compared to its competitor, Rituxan, with patients treated with GAZYVA and chemotherapy living nearly a year longer without disease worsening or death. Additionally, GAZYVA plus chemotherapy tripled the number of patients showing a complete response, with 26.1% achieving no evidence of disease compared to 8.8% for Rituxan and chemotherapy[1].

Competition and Market Share

The CLL treatment market is highly competitive, with GAZYVA facing stiff competition from GlaxoSmithKline's (GSK) Arzerra. Both drugs have received FDA approvals for first-line use in CLL, setting the stage for a competitive market landscape. However, GAZYVA's superior clinical data and regulatory approvals have positioned it favorably against its competitors[1].

Cost-Effectiveness and Pricing

GAZYVA's market trajectory is also influenced by cost-effectiveness considerations. In the UK, the National Institute for Health and Care Excellence (NICE) has recommended GAZYVA for patients who do not respond to other therapies, provided Roche offers the drug at a lower cost. This highlights the importance of pricing strategies in expanding market share[1].

Financial Impact

The financial performance of GAZYVA is closely tied to Roche's overall strategy to mitigate the impact of Rituxan's patent expiration. Rituxan, a blockbuster drug, generated $7 billion in global sales in 2013. Roche aims to transfer sales from Rituxan to GAZYVA before generic versions of Rituxan enter the market. The promising data and regulatory approvals for GAZYVA are crucial in this transition[1].

Market Forecast

The market forecast for GAZYVA indicates a positive trajectory, particularly in the context of lupus nephritis, a new indication area. The "GAZYVA Emerging Drug Insight and Market Forecast - 2032" report suggests that extensive research and incremental healthcare spending will expand the market size for lupus nephritis treatments. However, GAZYVA will face competition from emerging therapies, which could impact its market dominance[4].

Revenue Projections

While specific revenue projections for GAZYVA alone are not detailed, the overall performance of Roche's oncology portfolio, which includes GAZYVA, has been strong. The drug's market size is expected to grow significantly in the seven major markets (7MM) including the United States, EU5, and Japan, driven by its expanded indications and strong clinical data[4].

SWOT Analysis

Strengths

• Clinical Efficacy: GAZYVA has demonstrated superior clinical outcomes in CLL treatment.
• Regulatory Approvals: Multiple approvals in key markets, including the US and EU.
• Cost-Effectiveness: Recommended by NICE in the UK under certain pricing conditions.

Weaknesses

• Competition: Faces competition from GSK's Arzerra and other emerging therapies.
• Pricing Pressure: Needs to be offered at a lower cost to gain broader acceptance.

Opportunities

• Expanded Indications: Potential for use in lupus nephritis and other hematological malignancies.
• Global Market Growth: Increasing healthcare spending and research in key markets.

Threats

• Generic Competition: Looming patent expiration of Rituxan and potential generic competition.
• Emerging Therapies: New treatments in the pipeline could challenge GAZYVA's market share[4].

Conclusion

GAZYVA's market dynamics are characterized by strong clinical performance, strategic regulatory approvals, and a competitive market landscape. As Roche navigates the transition from Rituxan to GAZYVA, the drug's financial trajectory is expected to remain positive, driven by its expanding indications and strong market presence.

Key Takeaways

• GAZYVA has demonstrated superior efficacy in CLL treatment compared to Rituxan.
• The drug faces competition from GSK's Arzerra but has gained favorable regulatory approvals.
• Cost-effectiveness and pricing strategies are crucial for its market success.
• GAZYVA is expected to grow in the lupus nephritis market despite emerging competition.
• The drug's financial performance is tied to Roche's strategy to mitigate Rituxan's patent expiration.

FAQs

Q1: What is GAZYVA used for?

GAZYVA (obinutuzumab) is primarily used for the treatment of chronic lymphocytic leukemia (CLL) and is also being explored for other hematological malignancies and conditions like lupus nephritis.

Q2: How does GAZYVA compare to Rituxan?

GAZYVA has shown superior clinical outcomes in CLL treatment compared to Rituxan, with patients treated with GAZYVA and chemotherapy living nearly a year longer without disease worsening or death.

Q3: What are the key regulatory milestones for GAZYVA?

GAZYVA received FDA approval in 2013 for CLL treatment and subsequent approvals for use in combination with chemotherapy for previously untreated CLL patients.

Q4: How does GAZYVA's market performance impact Roche's financials?

GAZYVA's strong market performance is crucial for Roche as it aims to transfer sales from Rituxan to GAZYVA before generic versions of Rituxan enter the market.

Q5: What are the future market prospects for GAZYVA in lupus nephritis?

The market for lupus nephritis is expected to grow due to extensive research and incremental healthcare spending, with GAZYVA positioned to capture a significant share despite emerging competition.

Sources

1. FiercePharma: "Roche builds CLL case for Gazyva in two-horse race with GSK"
2. BusinessWire: "BeiGene Accelerates Global Momentum with Strong Second Quarter 2023 Financial Results"
3. IDEA Pharma: "Pharmaceutical Innovation Index 2018"
4. ResearchAndMarkets: "GAZYVA Emerging Drug Insight and Market Forecast - 2032"