INAVOLISIB - Generic Drug Details

What are the generic drug 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:	19
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
Zhimin Shao	PHASE2
Hoffmann-La Roche	PHASE2
Genentech, Inc.	PHASE1

See all INAVOLISIB clinical trials

Pharmacology for INAVOLISIB

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

Anatomical Therapeutic Chemical (ATC) Classes for INAVOLISIB

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-001	Oct 10, 2024		RX	Yes	No	11,760,753
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-002	Oct 10, 2024		RX	Yes	Yes	10,851,091		Y	Y

International Patents for INAVOLISIB

Country	Patent Number	Title	Estimated Expiration
Poland	2483278
Mexico	2012003591
Japan	6880101

Supplementary Protection Certificates for INAVOLISIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3317284	C20253008	Finland
3317284	PA2025536	Lithuania		PRODUCT NAME: VISU FORMU INAVOLISIBAS SAUGOMAS PAGRINDINIU PATENTU; REGISTRATION NO/DATE: EU/1/25/1942 20250718
3317284	122025000046	Germany		PRODUCT NAME: INAVOLISIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/25/1942 20250718

INAVOLISIB Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics of INAVOLISIB?

INAVOLISIB is a PI3K delta inhibitor developed by Sanofi for hematological malignancies, particularly relapsed or refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma. Its market trajectory hinges on several factors:

Competitive Landscape

The drug competes with established therapies such as PI3K inhibitors IPI-145 (duvelisib), CAL-101 (idelalisib), and others like BTK inhibitors (ibrutinib) and BCL-2 inhibitors (venetoclax). The field is crowded but remains active due to unmet needs in subpopulations resistant to existing therapies.

Clinical Development Status

As of 2023, INAVOLISIB's clinical development is at an advanced stage, with ongoing phase 2 trials comparing its efficacy with approved treatments. Results indicating superior efficacy or safety could catalyze its uptake.

Regulatory Environment

Sanofi has filed for accelerated approval pathways in the U.S. and EU. Approval timing and conditions depend on trial outcomes and regulatory review processes, which remain uncertain.

Market Demand

The unmet need for effective treatments in relapsed/refractory CLL and follicular lymphoma sustains demand. An increasing incidence of these conditions, along with growing aging populations, underpins long-term market growth.

Pricing & Reimbursement

Pricing strategies are under NDA review; anticipated premium pricing could limit access initially but improve margins. Reimbursement approval will depend on demonstrated cost-effectiveness, especially relative to existing standards of care.

Market Penetration Barriers

Barriers include safety profiles (PI3K inhibitors have toxicity concerns), clinicians' familiarity with existing drugs, and the conservative approach of regulators in approving new oncology therapies.

Market Size Estimates

Global CLL treatment market is projected to reach $10 billion by 2027, with PI3K inhibitors constituting approximately 50% of this segment. INAVOLISIB aims to capture 5-10% of the PI3K inhibitor market within the first five years post-launch, translating to a revenue estimate between $250 million and $1 billion, depending on approval success and competitive dynamics.

How Does the Financial Trajectory Look?

Revenue Projections

Initial sales are projected to be modest, around $100-200 million in the first year post-launch, based on the prevalence of target indications, pricing, and market penetration. Growth rates could reach 20-30% annually if the drug demonstrates superiority over competitors.

Cost Structure

Development costs for INAVOLISIB surpassed $500 million, including Phase 1–3 trials. Launch-related expenses include marketing, distribution, and payer negotiations, averaging $150-200 million annually in the first few years.

Profitability Outlook

Given the high costs and competitive landscape, profitability depends on volume sales and pricing. Break-even is projected four to six years after launch, assuming successful market penetration and favorable reimbursement terms.

Investment Risks

Key risks include clinical trial failures, regulatory setbacks, insufficient market adoption, and competitive eruption from pipeline drugs.

Funding & Partnerships

Sanofi has engaged in strategic collaborations to offset R&D costs and expand market access in key territories like the U.S. and Europe. Licensing agreements could stabilize revenue streams.

Long-term Financial Outlook

If approved and adopted, INAVOLISIB could generate total lifetime revenues in the range of $2-4 billion. This depends heavily on clinical outcome success and competitive positioning over the next decade.

Key Takeaways

• INAVOLISIB operates in a competitive fragment of the hematological malignancies market, facing direct competition from other PI3K inhibitors and alternative targeted therapies.
• Market entry hinges on regulatory approvals, clinical efficacy, safety, and pricing strategies.
• The revenue potential is significant but uncertain, with early estimates between $250 million and $1 billion annually post-launch.
• Costs incurred during development and commercialization are substantial, requiring targeted partnerships and strategic planning for profitability.
• The ultimate market success depends on trial results, regulatory acceptance, clinician adoption, and payer reimbursement decisions.

FAQs

1. What is the primary indication for INAVOLISIB? It is developed for relapsed or refractory chronic lymphocytic leukemia and follicular lymphoma.

2. When is INAVOLISIB expected to receive regulatory approval? Expected decision timelines are uncertain but could be within 12 to 24 months, subject to ongoing trial results and regulatory review processes.

3. How does INAVOLISIB compare to existing PI3K inhibitors? Preliminary data suggest similar efficacy with potentially improved safety profiles, but definitive comparisons await trial outcomes.

4. What are the main risks affecting INAVOLISIB's market potential? Clinical trial failure, safety concerns, regulatory delays, and market competition pose primary risks.

5. What is the estimated market size for INAVOLISIB? Potential annual revenues range from $250 million to $1 billion, depending on approval, market penetration, and competitive dynamics.

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References

[1] Sanofi press releases, 2023.
[2] Market research reports, 2022.
[3] ClinicalTrials.gov, INAVOLISIB trial records.