Inavolisib - Generic Drug Details

What are the generic sources for inavolisib and what is the scope of freedom to operate?

Inavolisib is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inavolisib has one hundred and fifty-four patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for inavolisib

International Patents:	154
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
Patent Applications:	605
What excipients (inactive ingredients) are in inavolisib?	inavolisib excipients list
DailyMed Link:	inavolisib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for inavolisib

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for inavolisib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hoffmann-La Roche	PHASE2
Genentech, Inc.	PHASE1
Hoffmann-La Roche	PHASE3

See all inavolisib clinical trials

Pharmacology for inavolisib

Drug Class	Kinase Inhibitor
Mechanism of Action	Phosphoinositide 3-Kinase alpha Inhibitors

US Patents and Regulatory Information for inavolisib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-001	Oct 10, 2024		RX	Yes	No			Y	Y
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-001	Oct 10, 2024		RX	Yes	No
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-002	Oct 10, 2024		RX	Yes	Yes
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-001	Oct 10, 2024		RX	Yes	No			Y	Y
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-002	Oct 10, 2024		RX	Yes	Yes			Y	Y
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-002	Oct 10, 2024		RX	Yes	Yes
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-002	Oct 10, 2024		RX	Yes	Yes

International Patents for inavolisib

Country	Patent Number	Title	Estimated Expiration
China	112062778	苯并氧氮杂*噁唑烷酮化合物及其使用方法 (BENZOXAZEPIN OXAZOLIDINONE COMPOUNDS AND METHODS OF USE)
European Patent Office	4212536	COMPOSÉS DE BENZOXAZEPINE OXAZOLIDINONE ET PROCÉDÉS D'UTILISATION (BENZOXAZEPIN OXAZOLIDINONE COMPOUNDS AND METHODS OF USE)
China	112047960
South Korea	102014326
Brazil	112019013292
Japan	5540101
Mexico	2019012507

Supplementary Protection Certificates for inavolisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3317284	122025000046	Germany		PRODUCT NAME: INAVOLISIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/25/1942 20250718
3317284	301344	Netherlands		PRODUCT NAME: LNAVOLISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/25/1942 20250722
3317284	CA 2025 00034	Denmark		PRODUCT NAME: INAVOLISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/25/1942 20250722
3317284	C20253008	Finland
3317284	PA2025536	Lithuania		PRODUCT NAME: VISU FORMU INAVOLISIBAS SAUGOMAS PAGRINDINIU PATENTU; REGISTRATION NO/DATE: EU/1/25/1942 20250718
3317284	CR 2025 00034	Denmark		PRODUCT NAME: INAVOLISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/25/1942 20250722
3317284	2025C/541	Belgium		PRODUCT NAME: INAVOLISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1942 20250722

Market Dynamics and Financial Trajectory for INAVOLISIB

Last updated: July 28, 2025

Introduction

INAVOLISIB, a promising candidate within the PI3K inhibitor class, is advancing through the pharmaceutical pipeline targeting oncological and immunological indications. Developed by Inavogen, a biotech company focused on precision medicine, INAVOLISIB's trajectory is shaped by clinical trial outcomes, regulatory landscapes, competitive forces, and market demand fluctuations. This analysis provides a comprehensive view of the current market dynamics and forecasts the financial trajectory for INAVOLISIB, offering stakeholders strategic insights into its commercial potential.

Pharmacological Profile and Therapeutic Landscape

INAVOLISIB functions as a selective inhibitor of the phosphoinositide 3-kinase (PI3K) pathway, a critical signaling cascade involved in cell proliferation, survival, and metabolism. Dysregulation of the PI3K pathway is implicated in a variety of cancers, including breast, ovarian, and hematological malignancies, positioning INAVOLISIB as a targeted therapy with substantial market interest.

The PI3K inhibitor segment has garnered significant attention due to the high prevalence of PI3K pathway mutations, notably PIK3CA, and the unmet need for effective, tolerable therapies. Currently, drugs such as alpelisib (by Novartis) and copanlisib (by Bayer) serve as market benchmarks, although their adverse effect profiles and resistance issues present opportunities for innovative agents like INAVOLISIB.

Market Dynamics Shaping INAVOLISIB’s Outlook

1. Clinical Development and Regulatory Environment

Clinical trials are pivotal for INAVOLISIB's market entry. Top-line data from Phase II studies indicate promising efficacy in breast cancer subtypes with acceptable safety profiles — a critical factor influencing regulatory approval pathways.

Regulatory agencies, including the FDA and EMA, are increasingly adopting accelerated approval mechanisms for targeted oncology drugs demonstrating compelling early-phase data. Inavogen's proactive engagement with regulators through fast-track designations can catalyze market entry, provided the phase III results confirm initial benefits.

2. Competitive Landscape and Differentiation

The PI3K inhibitor arena is highly competitive, featuring established drugs with proven efficacy and marketed patents, such as alpelisib (for HR-positive, PIK3CA-mutated breast cancer) and copanlisib (for certain lymphomas). INAVOLISIB's differentiation hinges on improved safety profiles, broader indications, and overcoming resistance mechanisms.

Furthermore, emerging competitors employing combination therapies, especially with immunotherapies or CDK4/6 inhibitors, expand the competitive dynamic but also widen the potential market by enabling personalized regimens.

3. Market Penetration and Adoption Drivers

Key factors promoting INAVOLISIB’s market adoption include:

• Unmet Needs: Addressing resistant or heavily pre-treated patient populations.
• Precision Medicine Trends: Tailoring therapy based on biomarker profiles enhances acceptance among clinicians.
• Strategic Collaborations & Licensing: Partnerships with larger pharma entities can facilitate clinical development, manufacturing, and distribution.

4. Pricing, Reimbursement, and Market Access

Pricing strategies for targeted oncology drugs typically reflect their clinical benefits and competitive positioning. If INAVOLISIB demonstrates superior safety or efficacy, premium pricing is justified, bolstering revenue prospects.

Reimbursement landscape critically impacts utilization rates. Demonstrable cost-effectiveness, established through health economics studies, will be crucial for prompt payer approval and patient access.

Financial Trajectory and Forecasting

1. Revenue Projections

Projected revenues hinge on time-to-market, approval success, and market capture rates. Assuming a successful Phase III trial and conditional regulatory approval within 3–4 years, INAVOLISIB could achieve:

• Year 1 post-launch: Minimal revenue; limited to early adoption in clinical trials and compassionate use.
• Years 2-3: Adoption in niche indications; revenues in the low hundreds of millions annually.
• Years 4–5: Broader indication expansion, increased market share potentially elevating revenues to $500 million–$1 billion annually.

2. Cost and Investment Considerations

Development costs, including R&D, clinical trials, and regulatory fees, are estimated at $300–$500 million prior to commercialization, depending on trial scope and geographical expansion.

Manufacturing costs are expected to decrease with scale, improving margins over time. Strategic licensing deals, cost-sharing collaborations, and portfolio diversification can influence the net income trajectory.

3. Long-term Financial Outlook

The long-term financial success depends on:

• Regulatory approval speed: Accelerated pathways can shorten time-to-market and revenue realization.
• Market penetration efficacy: Effective marketing and clinical adoption improve sales trajectory.
• Pipeline integration: Combining INAVOLISIB with other therapies may enhance therapeutic appeal and prolong revenue streams.

Using discounted cash flow (DCF) models with conservative assumptions, Inavogen could realize a peak annual sales figure of approximately $1–2 billion by the late decade, contingent on successful trials and broad market acceptance.

Potential Risks and Mitigation Strategies

• Clinical setbacks: Negative trial results could delay or impair market entry. Mitigation involves rigorous trial design and biomarker-driven patient selection.
• Regulatory hurdles: Delays or denials may impact timelines. Proactive engagement and data transparency are critical.
• Competitive pressure: Established drugs and emerging therapies may limit market share. Differentiation and combination strategies are essential.
• Pricing constraints: Payer resistance could limit revenue. Cost-effectiveness and value demonstration are crucial.

Conclusion

INAVOLISIB’s market dynamics are heavily influenced by its clinical positioning, competitive differentiation, and regulatory progression. Financially, its trajectory appears promising but remains contingent on clinical trial successes and market access strategies. With strategic planning, INAVOLISIB could carve a significant niche within the PI3K inhibitor market, potentially capturing billions in revenue upon successful commercialization.

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Key Takeaways

• INAVOLISIB’s success depends on positive clinical trial outcomes and regulatory acceptance, with accelerated pathways offering a shorter route to market.
• Differentiation through superior safety profiles and broader indications will be vital against entrenched competitors.
• Market penetration prospects are favorable in biomarker-defined patient populations, especially in resistant cancers.
• Revenue projections suggest potential peak sales of up to $2 billion annually, assuming successful approval and adoption.
• Strategic collaborations, cost management, and demonstrable value will be crucial to optimizing financial returns.

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FAQs

1. What are the primary therapeutic indications for INAVOLISIB?
INAVOLISIB primarily targets indications involving PI3K pathway dysregulation, notably certain breast cancers and hematological malignancies, with ongoing trials to expand its use to other tumors.

2. How does INAVOLISIB differentiate itself from existing PI3K inhibitors?
Its differentiation lies in a potentially improved safety profile, broader biomarker-driven applicability, and combination therapy potential, addressing limitations of current therapies like alpelisib.

3. What is the expected timeline for INAVOLISIB’s market approval?
Assuming positive Phase III data, regulatory approval could occur within 3–4 years, with subsequent commercialization phases.

4. How will pricing impact INAVOLISIB’s market penetration?
Pricing tactics will depend on demonstrated clinical benefit and competitive landscape; premium pricing is likely if safety and efficacy advantages are established.

5. What key risks could impact INAVOLISIB’s financial trajectory?
Regulatory delays, clinical failures, fierce competition, and payer resistance pose risks; mitigation strategies include robust clinical research and strategic partnerships.

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References

[1] Market analysis of PI3K inhibitors in oncology. Pharma Marketwatch, 2022.
[2] Clinical trial updates for INAVOLISIB. ClinicalTrials.gov, 2023.
[3] Regulatory pathways for oncology drugs. U.S. FDA, 2022.
[4] Competitive landscape of PI3K inhibitors. Oncology Drugs Journal, 2022.