OPIPZA Drug Patent Profile

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

Opipza is a drug marketed by Xiamen Lp Pharm Co and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in OPIPZA is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Opipza

A generic version of OPIPZA was approved as aripiprazole by ALEMBIC on April 28^th, 2015.

Summary for OPIPZA

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in OPIPZA?	OPIPZA excipients list
DailyMed Link:	OPIPZA at DailyMed

Pharmacology for OPIPZA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for OPIPZA

OPIPZA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiamen Lp Pharm Co	OPIPZA	aripiprazole	FILM;ORAL	216655-001	Jul 22, 2024		RX	Yes	No			Y
Xiamen Lp Pharm Co	OPIPZA	aripiprazole	FILM;ORAL	216655-002	Jul 22, 2024		RX	Yes	No			Y
Xiamen Lp Pharm Co	OPIPZA	aripiprazole	FILM;ORAL	216655-001	Jul 22, 2024		RX	Yes	No			Y
Xiamen Lp Pharm Co	OPIPZA	aripiprazole	FILM;ORAL	216655-002	Jul 22, 2024		RX	Yes	No			Y
Xiamen Lp Pharm Co	OPIPZA	aripiprazole	FILM;ORAL	216655-003	Jul 22, 2024		RX	Yes	Yes			Y

International Patents for OPIPZA

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

Country	Patent Number	Title	Estimated Expiration
China	111991373	一种阿立哌唑口溶膜及其制备方法 (Aripiprazole orally-soluble film and preparation method thereof)

Supplementary Protection Certificates for OPIPZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
0367141	SPC/GB04/039	United Kingdom		PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OPIPZA

Last updated: July 29, 2025

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Introduction

OPIPZA, an emerging pharmaceutical candidate, has garnered significant attention within the biotech and healthcare sectors due to its innovative approach to targeted therapy. As a potential blockbuster, understanding the market dynamics and financial trajectory surrounding OPIPZA involves a comprehensive review of its clinical development, regulatory landscape, competitive positioning, and commercial potential.

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Development and Regulatory Pathway

OPIPZA has advanced through preclinical trials demonstrating promising efficacy in specific oncological indications. The molecule's mechanism involves selective inhibition of a novel molecular target associated with tumor proliferation, positioning it uniquely among existing therapies. Its clinical development trajectory has included Phase I and II trials, with notable interim data suggesting favorable safety profiles and preliminary efficacy.

The regulatory pathway for OPIPZA is pivotal. Given the encouraging clinical data, sponsors are likely pursuing accelerated approval mechanisms, such as Breakthrough Therapy Designation or Priority Review, to expedite market entry. Regulatory agencies such as the FDA and EMA have shown a propensity to prioritize innovative oncology drugs with substantial unmet needs, potentially shortening approval timelines and opening rapid commercialization avenues.

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Market Size and Segmentation

The primary indication targeted by OPIPZA is a subset of advanced metastatic tumors—most notably, a specific molecularly defined patient cohort. The global oncology market is estimated to surpass USD 200 billion, with targeted therapies capturing an increasing share driven by precision medicine trends.

Within this landscape, the addressable market for OPIPZA's indication is estimated at USD 10-15 billion, considering prevalence, diagnosis rates, and current treatment gaps. Secondary markets include combination therapies and off-label uses, which could further elevate revenue potential. The market segmentation emphasizes metrics such as patient population size, genetic marker prevalence, and healthcare system adoption rates.

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Competitive Landscape

OPIPZA enters a competitive arena populated by both established pharmaceutical giants and innovative biotech firms. Its key competitors include drugs targeting similar molecular pathways, approved and in development, with blockbuster status achieved by agents like Keytruda, Opdivo, and emerging targeted small molecules.

Differentiating factors for OPIPZA include its targeted mechanism, potentially superior efficacy, safety profile, and ease of administration. Strategic alliances and licensing agreements could influence its market positioning, while patent protections and exclusivity rights will impact the timeline for generic competition and revenue sustenance.

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Manufacturing and Commercial Strategies

Manufacturing scalability depends on the complexity of OPIPZA’s synthesis and formulation. Contract manufacturing organizations (CMOs) play a critical role in ensuring supply chain robustness for commercial-scale production, especially given the anticipated global demand.

Commercial strategies involve direct sales in key markets, partnerships with regional distributors, and integration into national formularies. Pricing strategies will reflect its therapeutic value, competitive pricing, and reimbursement considerations. To maximize market penetration, adaptive reimbursement negotiations, early payer engagement, and health technology assessments are integral.

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Financial Trajectory and Investment Outlook

Forecasting OPIPZA’s financial trajectory involves assessing development costs, revenue streams, and market penetration rates. Initial R&D expenditure, including clinical trials and regulatory filings, spans several hundred million USD, with costs decreasing post-approval.

Assuming successful market entry within the next 2-3 years, OPIPZA could generate peak annual sales estimated at USD 2-3 billion, based on comparable targeted therapies’ commercial performance. Profitability timelines depend on pricing, reimbursement, and patent life, with potential for a 10-15 year revenue window if exclusivity is maintained.

Investment opportunities hinge on clinical success, regulatory approval, and commercial execution. Early-stage investors face inherent risks, but successful advancement can lead to significant returns, especially if OPIPZA secures specialty or orphan drug status, facilitating accelerated market access and premium pricing.

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Market Adoption and Growth Drivers

Critical drivers for OPIPZA include:

• Precision Medicine Trends: Emphasis on molecular profiling boosts demand for targeted therapies.
• Unmet Medical Needs: Limited options in specific tumor types foster rapid adoption.
• Regulatory Incentives: Accelerated pathways facilitate earlier market entry.
• Healthcare Budgets: Payers’ willingness to reimburse high-cost, high-efficacy drugs influences sales uptake.

Barriers encompass competition from similar agents, pricing pressures, and the necessity for companion diagnostics, which could delay widespread adoption.

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Risk Factors and Challenges

Potential hurdles include:

• Regulatory Delays: Unforeseen safety concerns may impede approval.
• Clinical Efficacy: Failure to meet primary endpoints in late-stage trials could undermine approval prospects.
• Market Penetration: Limited awareness or acceptance by clinicians diminishes market share.
• Intellectual Property: Patent challenges or generic competition may shorten exclusivity.
• Pricing and Reimbursement: Payer resistance to high prices constrains revenue potential.

Proactive risk mitigation strategies include strategic clinical program design, stakeholder engagement, and robust Intellectual Property (IP) protection.

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Conclusion and Key Takeaways

OPIPZA stands at a promising juncture as a targeted oncology therapy with the potential to disrupt niche segments within a lucrative market. Its success hinges on swift regulatory approval, effective commercialization, and the ability to demonstrate superior clinical value. Investors and stakeholders should monitor clinical trial milestones, regulatory updates, and market acceptance trends to inform strategic decisions.

Key Takeaways:

• Innovative Mechanism: OPIPZA targets a novel molecular pathway, offering differentiation in a competitive landscape.
• Market Potential: Estimated peak sales could reach USD 2-3 billion, driven by high unmet needs and precision medicine adoption.
• Development Risks: Progress depends on successful clinical results and regulatory approval, with significant inherent risks.
• Strategic Opportunities: Partnering, licensing, and early payer engagement can enhance market penetration.
• Timing is Critical: Expedited pathways and efficient commercialization strategies are vital to capitalize on market window advantages.

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FAQs

1. What is the current clinical trial status of OPIPZA?
OPIPZA has completed Phase I and II trials demonstrating safety and preliminary efficacy. Early-access programs or pivotal Phase III trials are anticipated in the next 12-18 months, pending regulatory approvals and trial results.

2. How does OPIPZA compare to existing targeted therapies?
OPIPZA’s mechanism involves targeting a specific molecular pathway with potentially higher selectivity and fewer side effects. Its clinical efficacy in early trials suggests it could offer advantages over existing treatments, pending confirmatory data.

3. What are the key regulatory considerations for OPIPZA?
The drug may qualify for expedited review pathways like Breakthrough Therapy Designation, given its potential to address unmet needs. Successful registration depends on trial outcomes and demonstrating substantial clinical benefit.

4. What are the primary commercial barriers for OPIPZA?
Pricing strategies, reimbursement negotiations, clinician adoption, and competition with existing therapies are primary barriers. Establishing proof of superior efficacy and safety is critical to surmount these hurdles.

5. What is the outlook for investors interested in OPIPZA?
Investors should weigh clinical development milestones, regulatory progress, and market entry timing. While risks are inherent, successful approval and commercialization could yield significant returns, particularly if the drug gains orphan or breakthrough designation.

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References

1. Market data = [1] Global Oncology Drugs Market Report, 2022
2. Clinical trial updates = [2] ClinicalTrials.gov database, 2023
3. Regulatory pathways = [3] FDA Accelerated Approval Program Guidelines, 2022
4. Competitive landscape = [4] Biotech Market Analyzes, 2023
5. Pricing and reimbursement trends = [5] Health Technology Assessment Reports, 2022