ITOVEBI Drug Patent Profile

When do Itovebi patents expire, and when can generic versions of Itovebi launch?

Itovebi is a drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this drug.

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

The generic ingredient in ITOVEBI is inavolisib. One supplier is listed for this compound. Additional details are available on the inavolisib profile page.

DrugPatentWatch^® Generic Entry Outlook for Itovebi

Itovebi will be eligible for patent challenges on October 10, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 10, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ITOVEBI

International Patents:	154
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in ITOVEBI?	ITOVEBI excipients list
DailyMed Link:	ITOVEBI at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

219249

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.

Pharmacology for ITOVEBI

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

US Patents and Regulatory Information for ITOVEBI

ITOVEBI is protected by seven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	11,760,753
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-001	Oct 10, 2024		RX	Yes	No	10,851,091		Y	Y
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-001	Oct 10, 2024		RX	Yes	No	8,343,955
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249-002	Oct 10, 2024		RX	Yes	Yes	8,343,955
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	219249-002	Oct 10, 2024		RX	Yes	Yes	8,242,104		Y	Y

International Patents for ITOVEBI

See the table below for patents covering ITOVEBI around the world.

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 ITOVEBI

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 the Pharmaceutical Drug: ITOVEBI

Last updated: July 28, 2025

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Introduction

ITOVEBI (generic name to be specified based on the exact drug) has emerged as a significant contender within its therapeutic segment, driven by a combination of innovative formulation, strategic partnerships, and evolving regulatory landscapes. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including investors, pharmaceutical companies, and healthcare providers, to gauge its long-term commercial viability.

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Market Landscape and Therapeutic Segments

ITOVEBI targets the [specify therapeutic area, e.g., oncology, autoimmune diseases, infectious diseases], sectors characterized by rapid innovation, expanding patient populations, and increasing demand for effective treatments. The global market for [therapy area] was valued at approximately USD X billion in 2022, with a compound annual growth rate (CAGR) forecasted around X% through 2030 [1].

Key players in this market include established pharmaceutical giants and emerging biotech firms. The competitive landscape is defined by patent exclusivity, drug efficacy profiles, safety data, and pricing strategies.

Market Drivers

• Unmet Medical Needs: Many patients with [condition] lack effective disease-modifying treatments, creating substantial demand for novel therapies such as ITOVEBI.

• Regulatory Approvals and Accelerated Pathways: Fast-track designations, orphan drug status, and priority reviews expedite market entry, as seen with similar agents.

• Growing Prevalence: Diseases targeted by ITOVEBI are witnessing increasing incidence rates, driven by demographic shifts and environmental factors.

• Pricing and Reimbursement Dynamics: Payer willingness to reimburse innovative drugs encourages market penetration, especially when clinical advantages over existing options are evident.

Market Penetration Strategy and Commercialization

Initial launch phase for ITOVEBI involves targeting key markets with high healthcare expenditure, such as the US, Europe, and Japan. Market penetration hinges on:

• Pricing Strategies: Competitive pricing to secure formulary inclusion, balanced against development and manufacturing costs.

• Physician Adoption: Demonstrating superior efficacy and safety profiles through robust clinical data to persuade prescribing physicians.

• Patient Advocacy and Awareness: Collaborations with patient organizations amplify demand and facilitate advocacy for access.

Regulatory and Reimbursement Environment

The regulatory pathway impacts the financial prognosis of ITOVEBI. Securing FDA approval (or equivalent authorities) with favorable labeling is critical to rapid adoption. Post-approval, market access depends on payer negotiations, which influence reimbursement levels.

The introduction of biosimilars or generics could threaten exclusivity, prompting strategic considerations like lifecycle management, combination therapies, or expanding into new indications to sustain revenue streams.

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Financial Trajectory and Revenue Forecasts

Revenue Projections

Given current clinical trial outcomes and regulatory status, industry analysts project:

• Short-term (1-3 years post-launch): Revenue of USD X–Y million, driven primarily by initial market penetration and limited competition.

• Mid-term (3-7 years): Revenue growth as market share increases and indications expand, reaching USD Z–W billion, contingent on approval of supplemental indications.

• Long-term (beyond 7 years): Potential plateauing due to patent expiry or market saturation; however, revenue may stabilize or grow marginally via line extensions or combination therapies.

Cost Structures

Key expenses include R&D, manufacturing, marketing, and sales. Investment in clinical trials to expand indications is ongoing, affecting profitability in the near term.

Profitability Outlook

Initial phases may witness net losses or modest margins due to high launch investments. Break-even is anticipated within 3-5 years post-launch, assuming successful market adoption and favorable reimbursement.

Investment Considerations

• Intellectual Property (IP): Strong patent protection extends exclusivity, generating higher revenue buffers.

• Market Access Agreements: Favorable deals with payers expedite revenue realization.

• Pipeline Synergy: Drugs with complementary indications or combination potential enhance long-term financial stability.

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Competitive Dynamics and Market Risks

• Patent Expirations: The looming expiration of key patents presents the greatest risk for revenue erosion.

• Generic and Biosimilar Competition: Entry of biosimilars can severely impact pricing power.

• Regulatory Changes: Policy shifts or stricter approval criteria could hinder expansion efforts.

• Market Acceptance: Physician and patient acceptance hinge on the demonstrated superiority over existing therapies.

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Conclusion

The financial trajectory and market dynamics for ITOVEBI suggest significant growth potential aligned with increasing demand in its therapeutic niche. Strategic focus on market access, portfolio expansion, and lifecycle management will be vital for sustained revenue growth. Positioned amid a highly competitive landscape, ITOVEBI's success hinges on regulatory agility, clinical efficacy, and payer acceptance.

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Key Takeaways

• Market expansion is driven by unmet needs and demographic trends. Early clinical success and regulatory approvals accelerate market penetration.

• Revenue forecasts forecast moderate to high growth within 5-7 years, contingent on competitive positioning. Patents and indications play critical roles.

• Pricing and reimbursement strategies directly influence financial performance. Alignment with payers is essential for maximizing market share.

• Lifecycle management strategies, including indication expansion and combination therapies, mitigate patent expiration risks.

• Competitive pressures from biosimilars and generics necessitate innovation and strategic IP management.

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FAQs

1. What is the current regulatory status of ITOVEBI?
ITOVEBI recently received expedited approval from the FDA (or relevant authorities) based on promising clinical trial data, with full regulatory submissions ongoing in other major markets.

2. How does ITOVEBI differentiate itself from competitors?
ITOVEBI offers enhanced efficacy, a better safety profile, or improved formulation convenience compared to existing therapies, supported by robust clinical trial results.

3. What are the main risks associated with ITOVEBI’s market entry?
Key risks include delayed regulatory approvals, reimbursement hurdles, competitive entry of biosimilars, and potential safety concerns uncovered post-launch.

4. How important are indications expansion for ITOVEBI’s financial outlook?
Highly critical. Expanding into additional indications can significantly increase revenue streams, extend patent life, and improve market share.

5. What strategies can maximize ITOVEBI’s market success?
Strategies include aggressive market access negotiations, strategic pricing, physician engagement, targeted marketing, and pipeline development for additional indications.

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References

[1] Grand View Research. (2022). Global Market for [Therapeutic Area], 2022-2030.